This is for the first time that a booster dose that is different from the one used for primary vaccination against Covid has been allowed in the country.
The sources told PTI that the Union Health Ministry's approval is based on the recommendations made recently by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI).
"Corbevax will be considered as a precaution dose after completion of six months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines for those aged above 18 years enabling use of Corbevax as a heterologous COVID-19 vaccine for precaution dose administration in this age group," the sources said.
This will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccine, the sources added.
All necessary changes in regard to the administration of precaution dose of Corbevax vaccine are being made on the Co-WIN portal.
India's first indigenously developed RBD protein subunit vaccine Corbevax is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunisation programme.
The COVID-19 Working Group (CWG), in its July 20 meeting, reviewed data of the double-blind randomised phase-3 clinical study which evaluated the immunogenicity and safety of booster dose of Corbevax vaccine when administered to COVID-19-negative adult volunteers of age 18-80 years previously vaccinated with two doses of either Covishield or Covaxin. `
"Following the examination of the data, the CWG observed that Corbevax vaccine can induce a significant increase in antibody titers when given to those who have received either Covaxin or Covishield, which is likely to be protective as per the neutralisation data also," the sources said.
The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above.
India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.
The country began inoculating children aged 12-14 from March 16 and also removed the comorbidity clause making all people aged above 60 eligible for the precaution dose of Covid vaccine.
India on April 10 began administering precaution doses of COVID-19 vaccines to all aged above 18 years.
The protective efficacy of Covaxin following the second and third dose immunisations were compared against the Delta variant and also studied the efficacy of Covaxin against Omicron variants in a Syrian hamster model in the study. The ICMR scientists also studied the antibody response, clinical observations, viral load reduction and lung disease severity after virus challenge.
"Protective response in terms of the reduction in lung viral load and lung lesions were observed in both the 2 doses as well as 3 doses Covaxin immunised group when compared to placebo group following the Delta variant challenge," the ICMR study said.
The study said that in spite of the comparable neutralising antibody response against the homologous vaccine strain in both second dose and third dose immunised groups, considerable reduction in the lung disease severity was observed in the third dose immunised group post Delta variant challenge indicating the involvement of cell mediated immune response also in protection.
"In the vaccine efficacy study against the Omicron variants i.e., BA.1 and BA.2, lesser virus shedding, lung viral load and lung disease severity were observed in the immunised groups in comparison to the placebo groups," the study underlined.
It said that the present study shows that administering of Covaxin booster dose will enhance the vaccine effectiveness against the Delta variant infection and give protection against the Omicron variants BA.1.1 and BA.2.
However, the findings of the study are a preprint and have not been certified by peer review.
The Drugs Controller General of India (DCGI) has also granted emergency use authorisation (EUA) to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 years.
भारत की कोविड से लड़ाई अब और अधिक मज़बूत @CDSCO_INDIA_INF ने
— Dr Mansukh Mandaviya (@mansukhmandviya) April 26, 2022
>6 से <12 आयुवर्ग के लिए 'Covaxin'
>5 से <12 आयुवर्ग के लिए 'Corbevax'
12 से ऊपर के आयुवर्ग के लिए 'ZyCoV-D' की 2 डोज को
'Restricted Use in Emergency Situations' की मंज़ूरी दी है।
ZyCoV-D is, currently, approved for a 2mg three-dose vaccination schedule.
The approval by the Drugs Controller General of India (DCGI) comes following recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation(CDSCO).
The SEC had last week reviewed the application of Biological E and Bharat Biotech seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group, respectively. It also reviewed Cadila's application.
Biological E's Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021.
India began inoculating children aged 12-14 on March 16.
The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year.
The next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.
India launched vaccination for all people aged more than 45 years from April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last year.
The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 years.
India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.
Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10.
Covaxin, one of the main vaccines administered to adults, is currently being administered to children in the age group of 15-18 years.
On Thursday, the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) had reviewed Bharat Biotech's application seeking grant of marketing authorisation for additional indication for Covid-19 vaccine for restricted use in emergency situations in the age group 6-12 years.
India’s COVID-19 vaccination coverage exceeded 187.95 Cr (1,87,95,76,423) as per provisional reports till 7 am today. This has been achieved through 2,30,89,167 sessions.
It is pertinent to mention here that COVID-19 vaccination for the age group 12-14 years started on March 16, 2022 . So far, more than 2.70 Cr (2,70,96,975) adolescents have been administered with the first dose of COVID-19 vaccine.
Similarly, the COVID-19 precaution dose administration for age group 18-59 years also started from April 10, 2022 onwards. 4,68,211 precaution doses have been administered in age group 18-59 years so far.
Individuals who recovered from Covid also showed significant immunity boost post-vaccination with Covaxin but lower than the breakthrough cases.
However, those who had taken two doses of Covaxin had very low neutralizing titres demonstrating the waning immunity after three months of the second dose of Covaxin, the study showed.
"The study highlights the significance of administering a booster dose or precaution dose of Covid vaccine as it provides better protection against the disease," Dr Pragya Yadav, a senior scientist at NIV Pune and the lead investigator of the study, told PTI.
The findings of the study, conducted in February this year after isolating the Omicron variant, have been published in the Journal of Infection on April 5.
"The impact of the third wave of the pandemic in India, caused by Omicron, triggered us to study the effectiveness of Covaxin against this variant.
"We assessed the sera of na ve, recovered and breakthrough cases vaccinated with Covaxin for its neutralising ability against Omicron and other variants," she stated.
As part of the study, participants were categorised into three groups -- 52 COVID-19 na ve individuals vaccinated with two doses of Covaxin with an average age of 41.7 years, 31 COVID-19 recovered cases vaccinated with two doses of Covaxin with average age of 41.7 years and 40 breakthrough cases after two-dose vaccination with Covaxin with an average age of 43.7 years.
The sera samples of na ve, recovered and breakthrough cases, were collected on average 97, 99 and 110 days, respectively.
The breakthrough infection was found to occur on average 43 days after the second vaccination.
A majority of the breakthrough cases had mild disease (95%) and two were asymptomatic, while 32.5% had co-morbidities like diabetes, hypothyroidism, hypertension, cardiac arrhythmias and allergic asthma.
"Breakthrough cases had the highest neutralising activity against all variants demonstrating a significant increase in the immune response post-infection. Recovered cases also showed significant immunity boost post-vaccination, but were lower than breakthrough cases.
"Apparently, the na ve cases had very low neutralizing titres against all the variants compared to the recovered and breakthrough cases," Dr Yadav stated.
The Omicron variant has shown a pronounced resistance to neutralization with the sera of all the three groups compared to B.1, Beta and Delta variants, she said.
Dr Yadav noted that Omicron was less effectively neutralized with the sera of na ve cases (12.9 fold) than recovered (7.98 fold) and breakthrough (8.84 fold) compared to B.1.
Although the immune response was less against the Omicron, it would still protect individuals from developing severe disease, hospitalization and mortality, she added.
The WHO said in a statement late on on Saturday that the Covaxin suspension was in response to the outcomes of its post EUL (emergency use authorisation) inspection, held between March 14-22, and the need to conduct process and facility upgrades to address recently identified GMP (good manufacturing practice) deficiencies.
"The World Health Organisation (WHO) is today confirming the suspension of supply of Covaxin produced by Bharat (Biotech) through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate," the global health agency said.
Bharat Biotech on Sunday said it had nothing else to add to an earlier statement where it said it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.
"During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical," it had said in a statement on April 1.
Hyderabad-based vaccine manufacturer Bharat Biotech then announced the temporary slowing down of its Covid vaccine Covaxin's production across its manufacturing facilities.
"Bharat Biotech announces the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand," it said.
The company will focus on pending facility maintenance, process and facility optimisation activities for the coming period, it said.
A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
There will be interruption of supply of Covaxin due to suspension of production for export, WHO said. The risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said.
Company officials could not be reached immediately for a response.
Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
During the recent WHO inspection, Bharat Biotech agreed with the former's team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO.
In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
As per Pfizer CEO Albert Bourla, the pharma czar is bringing soon a new Covid-19 vaccine that will include protection against Omicron.
"Here the situation has been deteriorated because of Omicron which had a very quick ramp-up. And we know that the two doses of the vaccine (Pfizer) offer very limited protection if any. The three doses, with the booster, they offer reasonable protection against hospitalization and deaths-- and, again, that's, I think, very good," he said in an interview to Yahoo Finance.
The pfizer CEO then declared, "Now, we are working on a new version of our vaccine-- the 1.1, let me put it that way-- that will cover Omicron as well. And, of course, we are waiting to have the final results. The vaccine will be ready in March. And the vaccine, we'll be able to produce it massively."
The above statements by Pfizer CEO seem very significant. Technologically developed mRNA vaccines proved not very efficient in stopping the spread of Omicron in USA.
For which, in a section of the US population, there is a growing chorus for introducing the 'Made In India' vaccine Covaxin in USA as showcased in a number of television interviews.
In an interview session by US TV Media NewsNation Now with Dr. Anthony Fauci, Chief Medical Advisor to the President of United States Joe Biden, the interviewer Adrienne Bankert had put a question on Covaxin and Omicron to Dr Fauci.
Here is the excerpt from the interview.
Bankert: One more question from a viewer Mike Doyle from Grand ledge Michigan, says, Why are traditional vaccines like the World Health Organization approved Covaxin, which is proven to be safe and effective in India, and which appears to have the potential to be effective against new variants being delayed for approval in the U.S.? We had so many people ask about Covaxin.
Fauci: We have enough vaccines, the best vaccines available in the United States. I’m puzzled by that question. We have more vaccines than we need right now. We just need people to get vaccinated with the vaccines that we have. The mRNA vaccines are desired by everyone else in the world. So we have what we need; we need to use it.
Bankert: Are you opposed to alternative treatments?
Fauci: What do you mean alternative? It’s not an alternative. It’s another vaccine. We don’t need another vaccine; we have plenty of vaccines, they have not applied to get approved. When you try to get approved, the FDA looks at the data, and if the data are in order and give you a good scientific rationale to approve it, the FDA will approve it. There are no interventions that are not being approved for reasons other than they’ve either not been submitted for approval or the data are not strong enough to warrant approval.
(Editor’s note – Covaxin was submitted for FDA emergency authorization this fall (October 2021). After the interview, Dr. Fauci offered this statement: Bharat Biotech, the company that has developed Covaxin, has applied to the FDA for an emergency use authorization (EUA) for their vaccine. The FDA is currently evaluating the data and no decision has been made).
Why The Chorus?
As per the data available with John Hopkins University, in the last 28 days, the new Covid-19 cases in USA had been over 76 lakh. And the death toll during the period in the country stood at 66,137.
In contrast, the cases in India during the last 28 days had been put at 32.95 lakh, and the count of Covid-19 fatalities during the same period in India had been 22, 261, the JHU data reveals.
Moreover, owing to high hospitalisation and deaths, though less than Delta wave in USA, the vaccine hesitancy in the country has been measured conspicuously.
Consider the following.
As per JHU data, in the last 28-day period, the USA had administered over 1.4 crore vaccines. But the total vaccine doses administered in India during the same period has been massive over 12.1 crore.
The above data shows the Omicron led wave in India has been well controlled by 'Made In India' vaccines like Covishield and Covaxin, unlike in the USA with m-RNA vaccines.
Come March, USA will release an Omicron-specific vaccine to shoot down the mutant-led wave in the country.
Covaxin is India's indigenous Covid-19 vaccine manufactured by Bharat Biotech, which has been developed in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
"Covaxin will be evaluated as a Covid-19 vaccine candidate in the United States. US biotech company Ocugen announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the company's Investigational New Drug Application (IND) to evaluate the Covid-19 vaccine candidate, BBV152, known as Covaxin outside the United States," the Hyderabad-based vaccine manufacturer said in a statement.
Ocugen is co-developing Bharat Biotech's Covaxin vaccine candidate for Covid-19 in the US and Canada.
Covaxin is one of the two vaccines which is being administered mainly in India.
Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries so far, according to the World Health Organization.
It was given emergency use approval by the Drugs Controller General of India (DCGI) for the 12-18 age group on December 24, 2021.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield.
The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.
"Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine," he had said.
In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
An expert panel of Central Drugs Standard Control Organisation (CDSCO) -- India's regulatory body for pharmaceuticals, medical devices and cosmetics -- on Wednesday recommended granting regular market approval to Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions.
"CDSCO has recommended for upgrade of Covishield and Covaxin's status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. The DCGI (Drugs Controller General of India) will evaluate the recommendations and give its decision," CDSCO said in a tweet.
Indian vaccines manufacturer Serum Institute of India and Bharat Biotech had submitted applications to the DCGI seeking regular market authorisation for their respective Covid vaccines.
Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute, had submitted an application to the DCGI on October 25 last year on this matter.
The DCGI had sought more data and documents from the Pune-based company following which Singh recently submitted a response along with more data and information.
Hyderabad-based Bharat Biotech had submitted complete information on chemistry, manufacturing, and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
The study conducted at Emory University demonstrated that subjects who received a booster dose of Covaxin (BBV152) six months after getting a primary two-dose series have witnessed neutralising of the SARS-CoV-2 Omicron and Delta variants, the vaccine major said in a statement.
Earlier studies had demonstrated the neutralising potential of Covaxin against other SARS-CoV-2 variants -- Alpha, Beta, Delta, Zeta and Kappa, it added.
Citing the study results, Bharat Biotech noted that more than 90 per cent of all individuals boosted with Covaxin showed neutralising antibodies.
"As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern. Data from this preliminary analysis show individuals receiving a booster dose of Covaxin have a significant immune response to both the Omicron and Delta variants.
"These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations," Emory Vaccine Center Assistant Professor Mehul Suthar, who led the laboratory analysis, noted.
Bharat Biotech Chairman and Managing Director Krishna Ella said the vaccine major is in a continuous state of innovation and product development for Covaxin.
"The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi-epitope vaccine generating both humoral and cell mediated immune responses.
"Our goals of developing a global vaccine against COVID-19 have been achieved with the use of Covaxin as a universal vaccine for adults and children," he added.
The study conducted at Emory Vaccine Center in Atlanta was sponsored by Ocugen, Inc. Bharat Biotech provided the sera of the subjects from the Phase 2 study.
Because, in as many as 9 districts, only around one-third of the population is fully vaccinated (means received 2 doses), and in 15 others, not even half of the population is fully vaccinated. In the remaining 6, more than half are fully immunised, with Khordha district inoculating 70 percent of the population.
Significantly, it's Khordha district that is topping the daily caseload Covid Chart in the State. Here is a big food for thought for those who abdicate social vaccine post taking Covaxin or Covishield.
As per the University of Glasgow Centre for Virus Research, the combined inference of laboratory experiments and real-world infection data had been the following.
Explaining Point Number 3
As per scientist Joe Grove at Glasgow Centre For Virus Research, SARS-CoV-2 can enter cells via two routes, both routes require spike activation by proteases ( are enzymes in the host that break down the protein). He further elaborated it.
Route 1: Cell surface fusion, triggered by TMPRRS2
What is TMPRRS2?
TMPRSS2 is an endothelial cell (means the cell layer that lines the cavities of heart, blood and lymph vessels to thoracic (lung region)) surface protein that is involved in the viral entry and spread of coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the virus that causes COVID19. Blocking TMPRSS2 could potentially be an effective clinical therapy for COVID-19.
Route 2: endosomal fusion, triggered by cathepsins (are also enzymes that degrades or dissolves the protein). (Omicron is taking this route)
As per scientist Grove, "Protection against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) associated disease (COVID-19) is currently reliant on a range of vaccine technologies that induce immunity to the spike protein of the virus."
He further added, "Delta (B.1.617.2) was responsible for significant waves of infections associated with an increase in reproduction number (R0). The secret behind the increased R0 is the variant harboured mutations at position 681, which is associated with enhanced cell entry."
But Omicron has undertaken such mutations that not only increased its cell-binding affinity vis-a-vis Delta but has also developed immune evasive capability.
The Glasgow Centre for Virus Research, therefore, concluded that the Omicron variant evades neutralisation by sera obtained from people vaccinated with 1 or 2 doses of vaccine, especially when antibody titres are waning.
It then added that Indicative studies have shown that 3 doses of Wuhan-strain based vaccines may provide only partial protection from infection with this variant.
Here Lies The Big Catch - Are Covishield, Covaxin booster dose efficient against Omicron?
If one goes by the Glasgow Centre for Virus Research study findings, then both the AstraZeneca (or its Indian equivalent Covishield) and desi vaccine Covaxin contain the Wuhan strain.
Covishield: As per SII data, developed by the University of Oxford and AstraZeneca. The vaccine works by delivering the genetic code of the SARS-CoV-2 (Wuhan Virus) spike protein to the body’s cell.
But in Omicron, the spike protein code stands changed. And as a consequence, the vaccine failed to detect the new mutant, the CVR study claimed.
Covaxin: As per Bharat Biotech data, the ingredients of COVAXIN contains 6µg (microgram) of whole-virion inactivated SARS-CoV-2 (Wuhan virus) antigen.
And as per CVR findings, since the Omicron has undergone mutations in the Spike protein, it can evade the vaccine-induced immune response from the host.
Last week, Prime Minister Narendra Modi had announced that Covid-19 vaccination for children between 15-18 years of age will be rolled out from January 3. According to official estimates, there are approximately 10 crore children in this age group.
On January 1, Union Health Minister Mansukh Mandaviya had requested people to register eligible children in their families.
Taking to Twitter, he said: "On the occasion of New Year, registration is being started on the CoWIN portal for immunisation of children against Covid-19 in the age group of 15 to 18 years from today. I request the family members to register the eligible children for vaccination."
Over 8,00,000 children have already registered for their dose in the past few days.
According to the guidelines, children can self-register online through an existing account on CoWIN or can also register by creating a new account through a unique mobile number or using their parent's accounts. Children can also get registered onsite by verifier or vaccinator; and they can walk in to take their shots.
Out of the 10 crore children eligible for the Covid vaccination, over 4.5 lakh teenagers have already received their first shots.
The vaccine used for inoculating children is Bharat Biotech's Covaxin, according to a set of new guidelines issued by the Union health ministry.
On December 24, the Drugs Controller General of India (DGCI), granted emergency use authorisation to the indigenously-developed Covaxin for children above 12 years of age.
Most of the schools and other educational institutions are being used as inoculation centres as well.
To avoid mixing-up of Covid vaccines for children and adults during administration, Mandaviya has also advised states and Union territories to make separate Covid vaccination centres (CVCs), separate session sites, separate queue (if adult vaccination is going on at the same centre) and separate immunisation team (if at same session site) for adults and children.
The vaccine manufacturer had conducted phase II/III, open-label, and multicentre studies to evaluate the safety, reactogenicity, and immunogenicity in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "Covaxin's clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically."
In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within one day. Pain at the injection site was the most commonly reported adverse event, claimed Bharat Biotech in the statement.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner. Group I consisted of children of age 12-18 years (n175), group II consisted of children of age 6-12 years (n175), and group III consisted of children of age 2-6 years (n175). Seroconversion was documented at 95-98%, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias, said vaccine manufacturer.
"On behalf of the frontline and healthcare workers, we hail the announcement of the Prime Minister for the precautionary booster dose for healthcare and frontline workers. It is the right step as the imminent third wave by the new variant is a matter of concern.
"Omicron is at our doorstep and we need to protect our healthcare and frontline workers in all possible ways", the IMA said in a statement.
On the ongoing RDA strike which has hit all the medical services in the national capital, the IMA said that the issue of expediting PG counselling is the need of the hour to increase manpower ahead of the looming third wave threat.
The infrastructure without manpower is a futile measure, it added.
The association has also welcomed the government's decision to inoculate children between 15-18 years of age.
J.A. Jayalal, National President of the IMA, said: "The IMA also welcomes the much-awaited decision of vaccination for children from January 3. At this moment of reopening of schools, this will be the welcome step to bring additional safety to children. The vaccination process for children must be handled with much more care and constant monitoring and surveillance must be ensured."
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
"The recommendations of the SEC were evaluated by another experts committee after which DCGI had sought additional data from the firm," a source said.
The DCGI gave its approval Friday, the source said.
The results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and present no serious safety concerns.
The latest study assessed 2,714 hospital workers at the All India Institute of Medical Sciences (AIIMS) in Delhi, from April 15 May 15, who were symptomatic and underwent RT-PCR test for COVID-19 detection.
Researchers noted that the Delta variant was the dominant strain in India during the study period, accounting for approximately 80 per cent of all confirmed COVID-19 cases.
Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the National Institute of Virology, Indian Council of Medical Research (NIV-ICMR), Pune, is an inactivated whole virus vaccine administered in a two-dose regimen, 28 days apart.
In January this year, Covaxin was approved for emergency use in India for people aged 18 and above. The World Health Organization (WHO) added the vaccine to its list of approved emergency use COVID-19 vaccines earlier this month.
The latest study was conducted during India's second COVID-19 surge and in healthcare workers who were primarily offered Covaxin.
"Our study offers a more complete picture of how BBV152 (Covaxin) performs in the field and should be considered in the context of COVID-19 surge conditions in India, combined with the possible immune evasive potential of the Delta variant," said Manish Soneja, Additional Professor of Medicine at AIIMS New Delhi.
"Our findings add to the growing body of evidence that rapid vaccine rollout programmes remain the most promising path to pandemic control while public health policies must continue to include additional protective measures, such as mask-wearing and social distancing," Soneja said in a statement.
The COVID-19 vaccination centre at AIIMS New Delhi exclusively offered Covaxin beginning January 16 this year to all of its 23,000 employees.
Researchers evaluated the effectiveness of the vaccine against symptomatic RT-PCR confirmed SARS-CoV-2 infection.
Of the 2,714 employees in the study population, 1,617 people tested positive for SARS-CoV-2, the virus that causes COVID-19, and 1,097 tested negative.
Positive cases were matched to negative RT-PCR tests (controls).
The odds of vaccination with Covaxin were compared between cases and controls and adjusted for occupational exposure to COVID-19, previous SARS-CoV-2 infection, and infection dates.
The study found that the vaccine effectiveness against symptomatic COVID-19 after two doses of Covaxin with the second dose administered 14 or more days before undergoing RT-PCR testing was 50 per cent.
The effectiveness of two vaccine doses remained stable over the seven-week follow-up period, the researchers said.
The adjusted vaccine effectiveness of the first dose, estimated after seven and 21 days, was low, which is consistent with the performance of other preventives against the Delta variant, they said.
"Findings from the study confirm previous research indicating that two doses of BBV152 are required to achieve maximum protection and that all vaccine roll-out plans must follow the recommended dosing schedule," said Parul Kodan, Assistant Professor of Medicine at AIIMS New Delhi.
"More research is needed to better understand how these findings translate to BBV152's effectiveness against delta and other variants of concern, especially related to severe COVID-19 infection, hospitalisation, and deaths," Kodan said.
The authors acknowledge that the vaccine effectiveness of Covaxin estimated in this study is lower than the efficacy reported by the recently published phase 3 trial. They noted that several factors may be responsible for the lower vaccine effectiveness in the latest study.
The researchers said this study population only included hospital employees who may have a higher risk of exposure to COVID-19 infection than the general population.
The research was conducted during the peak of India's second wave of COVID-19 with high test positivity rates for both hospital employees and residents of Delhi, they said.
Prevalence of circulating variants of concern, especially Delta, may have also contributed to the vaccine's lower effectiveness, according to the researchers.
The authors acknowledge several limitations to their study.
The study does not estimate the vaccine effectiveness against hospitalisation, severe disease, and death, which require further assessment, they noted.
Also, the study was not designed to estimate vaccine effectiveness for different time intervals after vaccination or to determine if vaccine effectiveness changed over time, the researchers added.
A source with the Ministry said that at present, 110 countries have agreed to mutual recognition of vaccination certificates and those who recognise Indian vaccination certificates of travellers fully vaccinated with Covishield or World Health Organisation(WHO)-approved Covid vaccines.
As per the new travel guidelines issued by the Union Health Ministry, if a fully vaccinated traveller is coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines, they will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival.
If partially or not vaccinated travellers visit India, they will have to submit their sample for post-arrival Covid-19 test at the point of arrival after which they will be allowed to leave the airport. They will have to be undergo home quarantine for seven days and undertake re-test on the eighth day of arrival in India and if found negative, further self-monitor their health for next seven days.
"Travellers artiving from countries excluding those at risk, will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival. This is applicable to travellers from all countries, including with which reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines also exist," said the new international arrival guidelines.
Of eight WHO-approved vaccines against Covid-19 in emergency use listing, two vaccines -- Covaxin and Covishield -- are from India.
The efficacy data which was peer reviewed also said the vaccine demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent safety against the Delta variant besides showing 70.8 per cent guard against all variants of SARS-CoV-2 virus.
The efficacy analysis demonstrated that Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19.
"The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals."
"The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen," Bharat Biotech Chairman Krishna Ella said in a statement.
The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India's largest ever clinical trial conducted for a Covid-19 vaccine.
Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said, following successful isolation of the SARS-CoV-2 virus at NIV, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnerships to develop the virus isolate into an effective COVID-19 vaccine.
"I am delighted to see that the phase III efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines," Bhargava said.
The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of "Atmanirbhar Bharat" along with the Indian academia and industry in fighting against the odds and carving a niche in the global community, he added.
Recently, the World Health Organisation granted emergency use listing to Covaxin, enabling countries to expedite their regulatory approval to import and administer doses.
The jab has also received emergency use authorisations in several countries with applications in process in more than 50 countries worldwide.
Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.
With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the COVID-19 pandemic, the statement said.
Covaxin is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021.
Bharat Biotech is poised to achieve its goal of an annualised capacity of about 1.0 billion doses of the jab by the end of 2021.
Covishield, the India-manufactured Oxford-AstraZeneca COVID-19 vaccine, was added to the UK's approved list last month.
"More good news for Indian travellers to the UK. From 22 November travellers fully vaccinated with a COVID19 vaccine recognised by WHO for Emergency Use Listing, including Covaxin, will not have to self-isolate; so joining those fully vaccinated with Covishield," Alex Ellis, British High Commissioner to India, said on Twitter on Monday.
The changes will come into effect at 4 am on November 22.
Besides Covaxin, China's Sinovac and Sinopharm, both on the WHO Emergency Use Listing, will be recognised by the UK government as approved vaccines for inbound travel, benefitting fully vaccinated people from the United Arab Emirates and Malaysia. These fully vaccinated passengers will not be required to take a pre-departure test, day-8 test or self-isolate upon arrival.
"As we continue to recover from the pandemic and expand our recognition of international vaccines, today's announcements mark the next step in our restart of international travel," said UK Transport Secretary Grant Shapps.
"The red list and quarantine system remain vital in protecting our borders and as we've said, we will not hesitate to take action by adding countries to the red list if necessary," UK Health Secretary Sajid Javid said.
The UK government has also simplified the travel rules for all under-18s coming to England. They will now be treated as fully vaccinated at the border and will be exempt from self-isolation requirements on arrival, day-8 testing and pre-departure testing. They will only be required to take one post-arrival test and a confirmatory free PCR test if they test positive.
"The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children two-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India," it said in a statement.
Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.
A Phase 2/3, open-label, multicentre study was conducted in India from May 2021 to July 2021, to evaluate the safety, reactogenicity and immunogenicity, of the whole-virion inactivated SARS-CoV-2 Vaccine in healthy volunteers in the above mentioned age group.
Covaxin was evaluated in three age groups: two-six years, six-12 years and 12-18 years. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart, added the statement from Ocugen.
The neutralising antibody responses against wild-type strain in the paediatric age group of two-18 years were equivalent to those seen in adults, aged 18 and above, in Bharat Biotech's large Phase 3 efficacy and safety trial.
"Filing for EUA in the US for pediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen.
Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalisations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study, the statement added.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.
Australia has already recognised Covishield.
"Today, the Therapeutic Goods Administration (TGA) determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status, Australia's medicines and medical devices regulator TGA said in a tweet.
This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV.
In recent weeks, the TGA has obtained additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19.
The supporting information has been provided to the TGA from the vaccine sponsor and/or the World Health Organisation.
Today, the @TGAgovau determined that Covaxin (manufactured by @BharatBiotech,) vaccine would be 'recognised' for the purpose of establishing a traveller's vaccination status, Australia's High Commissioner to India Barry O'Farrell AO said on Twitter,
Importantly, recognition of #Covaxin, along with the previously announced recognition of #Covishield (manufactured by @AstraZenecaIn), means many citizens, as well as other countries, will now be considered fully vaccinated on entry to Australia, he said in another tweet.
The WHO's Technical Advisory Group in a meeting on Tuesday agreed upon to conduct the final risk assessment after receiving additional data from manufacturer.
Hyderabad based Bharat Biotech is expected to submit the data by this weekend. The Technical Advisory Group may meet for the final risk-benefit assessment on November 3. The company also submitted additional info at WHO's request on September 27.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL) provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
"If all is in place and all goes well and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so," Margaret Harris, a spokeswoman for WHO, was quoted as saying at a UN press briefing.
The Hyderabad-based Bharat Biotech had applied to the WHO on April 19 for Covaxin's Emergency Use Listing (EUL).
The WHO had earlier said that it will carry out the risk and benefit assessments before granting the EUL to determine if a manufactured vaccine is quality-assured, safe and effective.
The company also submitted additional info at WHO's request on September 27.
Last week, a top official of the WHO said that while the process of "thoroughly evaluating a vaccine for use" can take a long time, it's necessary to give the right advice.
"The World Health Organisation is very clear that we want all countries to recognise vaccines that have been given an Emergency Use Listing (EUL) by the WHO advisory process. But it's also very important that WHO, when it makes a recommendation like that, is making that globally," WHO Health Emergencies Programme Executive Director Dr Mike Ryan had said.
The WHO approval is key for millions of Indians, who have taken Covaxin, to travel abroad. Without a WHO nod, the two-dose Covaxin is unlikely to be accepted as a valid vaccine by countries across the world.
The WHO has so far included only six Covid vaccines in its EUL list that includes the Oxford-AstraZeneca vaccine, manufactured as Covishield by the Serum Institute of India.
Refusing to interfere in the matter, a bench comprising Justices D.Y. Chandrachud and B.V. Nagarathna told the petitioner's counsel, "We do not want this matter to be argued at all. Let us not cast doubt on the vaccination".
The Counsel appearing for petitioner Mathew Thomas urged the bench to hear his arguments in the matter in detail. However, the bench responded that it was not keen on entertaining the plea.
The top court told the petitioner's counsel that it finds no error with the high court decision in the matter, and it will not entertain the petition.
The top court was hearing a plea challenging the Karnataka High Court order, which dismissed a PIL seeking directives to stop mass vaccination of Covishield and Covaxin. The court had also imposed a cost of Rs 50,000 on the petitioners for wasting precious time of the court.
In May this year, the high court, dismissing the plea, had said it was not filed in public interest and it was a fit case to impose exemplary costs as it is consumed 45 minutes, which could have been devoted to deal with important issues arising out of Covid-19.
In the high court, the petitioner's counsel had argued that it is not clear under what authority of law the Centre permitted vaccination without completing clinical trials.
Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for its vaccine.Swaminathan, the WHO's Chief Scientist, said on Twitter on Sunday that the technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) for Covaxin.
@WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere," she said in the tweet.
Earlier this month, the WHO said that Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the WHO's request on September 27. The WHO experts are currently reviewing this information and if it addresses all questions raised, the WHO assessment will be finalised next week."
The Geneva-based WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in to accelerate the overall review process.
According to the WHO, submissions for pre-qualification or listing under the emergency use procedure are confidential.
If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.
Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on the data meeting the WHO's criteria, according to the agency.
The indigenously-developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator Drugs Controller General of India (DGCI) and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.
Bharat Biotech recently said it has submitted all data pertaining to Covaxin to the WHO for the EUL and is awaiting feedback from the global health watchdog.
"#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback," Bharat Biotech had tweeted last month.
"We are diligently working with the WHO to obtain EUL at the earliest, the company had said on Tuesday.
India, the world's largest producer of vaccines overall, suspended exports of COVID-19 vaccines in April to focus on inoculating its own population following a sudden spike in infections.
Last month, Union Health Minister Mansukh Mandaviya announced that India will resume the supplies abroad.
According to Johns Hopkins University, the coronavirus has claimed 4,897,386 lives along with 240,559,605 confirmed cases across the world so far.
According to news agency ANI, the Subject Expert Committee (SEC) has given the necessary approval for the administration of the anti-Covid vaccine to children.
"Subject Expert Committee (SEC) has given a recommendation to DCGI (Drugs Controller General of India) for the use of BharatBiotech's Covaxin for 2-18 year olds," the news agency tweeted.
Subject Expert Committee (SEC) has given a recommendation to DCGI (Drugs Controller General of India) for the use of BharatBiotech's Covaxin for 2-18 year olds: Official sources
— ANI (@ANI) October 12, 2021
The phase-2 and phase-3 trial of the vaccine on children have been completed. Earlier this month, Bharat Biotech had submitted the trial data on Covaxin for children in the 2-18 years age group to the DCGI.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
"After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions," a source quoted SEC as having stated in its recommendations.
The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.
Speaking on the development, Dr E Venkata Rao, chief of clinical trial of Covaxin said, "In the phase-2 trial, it was confirmed that Covaxin can be administered to children above the age of 12 years. When the vaccine was rolled out, testing was conducted on the children between 2 and 18 years and it was found that the vaccine is safe and effective."
"Even before the approval of the DCGI, we were of the view that Covaxin will be safe and effective on children, given the fact that it is being administered to pregnant women and breastfeeding women," he added.
(With PTI Inputs)
Bijay Mohapatra revealed these facts while speaking about the sero-survey conducted in the state recently by the Indian Council of Medical Research (ICMR). Mohapatra stated that the sero-survey report provided positive information regarding the presence of antibodies among people of Odisha.
The Health Services Director also asserted that the condition of vaccinated people has also improved as compared to earlier, which is a positive sign.
Video Editor: Surendra Pradhan
Producer: Diptyranjita Patra
(IANS)
"Vaccination is the most important thing to strengthen the country's fight against coronavirus. Released the first commercial batch of #COVAXIN from Bharat Biotech's plant at Ankleshwar, Gujarat today. This will increase the supply of vaccine in the country and will help the vaccine reach every Indian," Mandaviya said on social media.
In May, Bharat Biotech had announced that it planned to produce an additional 200 million doses of Covaxin at its subsidiary Ankleshwar-based facility.
India's vaccination coverage against coronavirus under the mass vaccination drive has crossed the landmark of 63 crore. Over 73 lakh doses have been administered in the last 24 hours.
However, India reported a total of 45,083 new Covid-19 cases and 460 deaths in the last 24 hours, according to the health ministry's data. The active caseload in the country stands at 3,68,558. The surge in daily Covid cases has been driven by a recent spike in Kerala, which accounts for more than half of all the active Covid-19 cases in the country, followed closely by Maharashtra.
The ICMR in its recent study has found that the people already infected with Covid-19 while taking a dose of Covaxin have the same or increased antibody response as unaffected people taking two doses of Covaxin.
The pilot study was undertaken to examine SARS-CoV-2 specific antibody responses after day 0 (baseline before vaccination), day 28A2 days post-first dose (month 1) and day 56A2 days post-first dose (month 2) of BBV152 in a group of healthcare professionals as well as frontline workers.
The antibody responses of individuals with confirmed pre-vaccination SARS-CoV-2 infection were compared with those individuals without prior evidence of infection.
The blood specimens were collected from healthcare professionals and frontline workers who received BBV152 vaccine at vaccination centres in Chennai, India, during February to May 2021.
Blood samples were collected before receiving the first dose of BBV152. Prior infection with SARS-CoV-2 was determined by SARS-CoV-2 IgG positivity at baseline. The study was approved by the Ethics Committee of ICMR-NIRT.
Antibody levels were measured at three time points: on the day of vaccination (baseline), at month one following the first dose and at month two following the first dose.
The results were determined via a calibration curve, which is an instrument specifically generated by two-point calibration and a master curve provided via the reagent QR code.
Almost all participants with prior Covid-19 infection except two had detectable antibodies at the time of vaccination. This study offers evidence in support of public health-oriented and immunologically sustained vaccine strategies.
Lokesh Sharma, Scientist and Media Coordinator, ICMR, says, "This is a pilot study. If such findings are confirmed in large population studies, a single dose of BBV152 vaccine may be recommended to previously confirmed Covid patients so that the naA-ve individuals could attain the larger benefit of a limited vaccine supply."
(IANS)
The study also found that immunisation with a combination of Covishield and Covaxin was safe and the adverse effects were also found to be similar when compared to the same dose regimen.
The study titled Serendipitous COVID-19 Vaccine-Mix in Uttar Pradesh, India: Safety and Immunogenicity Assessment of a Heterologous Regime' has been uploaded on medRxiv, a preprint server and is yet to be peer-reviewed.
"To the best of our knowledge, this is the first study which reports the effects of heterologous prime-boost vaccination with an adenovirus vectored vaccine followed by an inactivated whole virus vaccine," the researchers said.
The immunisation program against COVID-19 in India started with two vaccines--adenovirus vector platform-based vaccine Covishield and inactivated whole virion BBV152 -Covaxin--and homologous prime-boost approach was followed. However, 18 individuals, under the national program, in Siddarthnagar, Uttar Pradesh inadvertently received Covishield as the first jab and Covaxin as the second.
The nationwide vaccination program at this time had entered in its fourth month of its existence and the event of mixed dosing raised considerable anxiety in the public domain with a potential to contributing to vaccine hesitancy.
The study was conducted against this backdrop.
So, including these 18 individuals who had received one dose of Covishield and second dose of Covaxin, 40 recipients of two doses of Covishield and 40 recipients of two doses of Covaxin, were recruited in the study. The study duration was from May to June 2021.
"We compared the safety and immunogenicity profile of them (18 individuals) against that of those receiving either Covishield or Covaxin. Lower and similar adverse events following immunisation in all three groups underlined the safety of the combination vaccine regime.
"Immunogenicity profile against Alpha, Beta and Delta variants in the heterologous group was superior and IgG antibody and neutralising antibody response of the participants was also significantly higher compared to that in the homologous groups," the study stated.
"The findings suggest that immunisation with a combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine was not only safe but also elicited better immunogenicity," it said.
The reactogenicity analysis was carried out based on solicited local and systemic AEFIs reported in the three groups within seven days of immunisation. None of the participants enrolled in the study had any serious AEFI within 30 minutes of immunisation with the first or second dose.
The most common local AEFI reported after first and second dose was pain at injection site.
No other local AEFI such as erythema, induration, pruritis or pustule formation was recorded by any of the participants. Most commonly reported systemic AEFI were pyrexia and malaise.
No other systemic AEFIs like urticaria, nausea, vomiting, arthralgia or cough was reported. The pyrexia was of low to moderate grade and was managed by administration of paracetamol and subsided in all participants within three to four days post-vaccination, according to the study.
"Despite the high median age of the participants of the heterologous group (62 years) in our study, the reactogenicity profile demonstrated that mixing of the two vaccines based on different platforms is safe," the study said.
The study demonstrates that immunisation with a heterologous combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine is safe and elicits better immunogenicity than two doses of homologous vaccination, using the same vaccines.
These findings have an important implication for the COVID-19 vaccination program wherein heterologous immunisation will pave the way for induction of improved and better protection against the variant strains of SARS-CoV-2.
Such mixed regimens will also help to overcome the challenges of shortfall of particular vaccines and remove hesitancy around vaccines in people's mind that could have genesis in programmatic 'errors' especially in settings where multiple COVID-19 vaccines are being used, the study highlighted.
However, to conclusively prove these findings a multicentre RCT needs to be carried out, the study underlined.
Union Health Minister Mansukh Mandaviya was responding to a question on the current capacity to manufacture Covaxin and Covishield in the country, and the expected capacity going forward from August to December 2021.
"As communicated by the manufacturers, the monthly vaccine production capacity of Covishield is projected to be increased from 110 million doses per month to more than 120 million doses per month and the production capacity of Covaxin is projected to be increased from 25 million doses per month to around 58 million doses per month," the minister said in a written reply.
Further, the Department of Biotechnology under the Ministry of Science and Technology has launched 'Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission'.
The Mission is being implemented by Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking (PSU) of the Department of Biotechnology, the reply stated.
Under the Mission, facility augmentation of Bharat Biotech and one state public sector enterprise and 2 central public sector enterprises (PSEs) -- Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited (IIL), Hyderabad and Bharat Immunologicals Biologicals Limited (BIBCOL), Bulandshahr -- for production of Covaxin have been supported.
In addition, technology transfer of Covaxin production to Gujarat COVID Vaccine Consortium (GCVC), including Hester Biosciences and OmniBRx Biotechnologies Pvt Ltd, led by Gujarat Biotechnology Research Centre (GBRC) of Department of Science and Technology, Government of Gujarat, has also been facilitated, the reply said.
Further, the Centre has also extended financial assistance to one of the domestic manufacturers for 'At-risk manufacturing', advance payment against the supply orders placed with Serum Institute of India and Bharat Biotech, besides streamlining regulatory norms for approval of vaccines, the reply added.
Covaxin is developed by the Bharat Biotech in collaboration with ICMR and National Institute of Pune.
The study states: "The sera of individuals who were fully immunized (with 2 doses) didn't show significant fold-reduction in the NAb titer against Delta, Delta AY.1 and B.1.617.3."
Delta Plus is a mutated form of the Delta variant and was first discovered in India. It is characterised by increased transmissibility and spike protein mutations.
The study points that Delta variant with its characteristic spike protein mutations has mutated further into four sub-lineages with an additional mutations which are associated with higher transmission and probable immune escape.
Last week, Union Science and Technology Minister Jitendra Singh informed parliament last week that 70 cases of the Delta Plus variant were found by INSACOG, a group of 28 laboratories involved in genome sequencing.
Covaxin along with other two vaccines -- Covishield and Russia's Sputnik -- has formed the trio for India's massive vaccination drive against the virus.
The research further states, "A significant increase in the NAb titer against B.1 variant in recovered cases with vaccination and breakthrough cases was observed compared to the Covid-19 native vaccines. Similarly, a significant increase in NAb titer was also observed among these two groups against Delta, Delta AY.1 and B.1.617.3 variants."
"This demonstrates the possible role of memory cells in immune boosting with post-infection or infection after immunization. The comparative analysis of all the groups revealed that the B.1.617.3 variant seems to be less susceptible to neutralization followed by Delta AY.1 and Delta variants."
The study on efficacy analysis further establishes Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19 cases and 63.6 per cent protection against asymptomatic Covid-19.
Bharat Biotech Chairman and Managing Director Krishna Ella said all documents required for EUL of Covaxin have been submitted to WHO as of July 9.
"The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," he said.
The Hyderabad-based company had said in May that that application for EUL was submitted to WHO-Geneva and regulatory approvals are expected by July-September 2021.
On June 30, the vaccine maker announced that it is working closely with the WHO for inclusion of Covaxin in its EUL.
"Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," it had said.
"We are a step closer to the final decision on Covaxin's global acceptance, as the rolling data is slated to begin in July 2021," it added.
The company claims that with 10 scientific publications in 12 months, Covaxin is one of the very few vaccines to have extensive data published in globally-renowned peer-reviewed journals.
In a detailed statistical report, the Odisha government has elucidated that despite allocation of 925560 doses of vaccines (Covishield - 756660 & Covaxin - 168900) in the month of June, private vaccination centres procured only 66500 doses (Covishield - 59000 & Covaxin - 7500) for vaccination which is a paltry 7.2% of the total, thereby leaving the 859060 doses as balance.
The State government had recently collaborated with all the private hospitals in the districts/municipal corporations to aggregate their demands for vaccine procurement for July 2021, but the response for procurement of doses is very much limited.
For the month of July, while the Centre has allocated 1016970 doses (Covishield - 843930 & Covaxin - 173040), the demand from the private hospitals have been a meagre total 156830 (Covishield - 126920 & Covaxin - 29910) which is just 15.4% of the total. The difference between the demand and allocation means that there is likelihood that Odisha may miss out from the balance 860140 doses of vaccines.
In a letter to the Health Ministry, ACS PK Mohapatra has expressed concern that in this context, the State is losing huge quantity of vaccines allocated for private hospitals.
While Odisha is capable of vaccinating 3.5 lakh beneficiaries per day, the Centre has allocated 3050910 doses to the State for the month of July, which will be consumed within 8 to 10 days, the State government pointed out in the letter to the Centre.
Mohapatra has pointed out that around 859060 balance doses of vaccines of June and 860140 doses of July 2021 which were allocated to the private hospitals but not procured for vaccination be diverted to the quota of State government so that Odisha is not disadvantaged.
It may be mentioned here that the State government had recently requested the Centre to revise the government: private allocation ratio from 75:25 to 95:5 due to low presence of private medical care entities in the health sector of the State.