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.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for treatment of adult patients with SpO2 93 per cent and who have high risk of progression of the disease, including hospitalisation or death, subject to certain conditions.
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax.
"The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO," an official source said.
Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.
Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses.
In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.
As for Biological E's Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.
The committee noted that the firm has submitted six months safety follow up post second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.
The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said.
"After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions," the source said.
The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius,the source added.
The SEC on Monday also recommended granting permission to manufacture and market anti- Covid pill Molnupiravir for restricted emergency use for treatment of adult COVID-19 patients with SpO2 93 per cent and who have high risk of progression of the disease, subject to certain conditions.
Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in emergency situation along with various supporting documents. including clinical data in the country, official sources said.
As per conditions, the drug should be sold by retail only under prescription of medical specialists.
According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage.
However, if it was initiated before hospitalisation due to COVID 19, it may be continued, sources said.
It is not authorsied for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women.
The US Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.
Before that in November Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat Covid-19.
The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19.
In a clinical trial of high risk people during the ealry course of illness,t he Merck's drug was shown to reduce hospitalisations and deaths by around 30 per cent.
As the Covid pandemic inflicts a heavy toll on countries around the globe, the U.S. Chamber strongly encourages the administration to release the millions of AstraZeneca vaccine doses in storage – as well as other life-saving support – for shipment to India, Brazil, and other nations hard-hit by the pandemic, said Myron Brilliante, executive vice president and head of international affairs at the US Chamber of Commerce.
He said these vaccine doses will not be needed in the United States, where it’s estimated that vaccine manufacturers will be able to produce enough doses by early June to inoculate every American.
This move would affirm US leadership, including in initiatives such as COVAX, and as we work with partners around the globe because no one is safe from the pandemic until we are all safe from it, Brilliante said.
The US Chambers issued the statement after Indian External Affairs Minister S Jaishankar sought global help in fight against COVID-19. Will strive to ensure that our supply chains are as smooth as possible in a difficult global situation. The world must support India, as India helps the world, he said in a tweet.
US State Department Deputy Spokesperson Jalina Porter told reporters that the United States continues to work closely with India to facilitate the movement of essential supplies and also address the bottlenecks of the supply chains.
The COVID-19 situation in India is a global concern, she said.
We also continue to collaborate with our partners in India to battle this at the highest level. We know Secretary (of State, Tony) Blinken spoke to his counterpart on Tuesday and we remain deeply engaged with India at all levels as we work to combat this crisis of the pandemic together, Porter said.
Congresswoman Rashida Talib tweeted that the COVID-19 crisis in India is a harsh reminder that the pandemic is not over until the whole world is safe.
President Biden must support a patent waiver to ramp up global production now, she said.
As we look to our Indian friends battling this pandemic, we’ll also acknowledge the toll that it’s taking, not only on the people of India, but as well as all throughout South Asia and, quite frankly, all over the world, Porter said.
The Washington Post in a lead editorial hoped that all of India can seize the moment and begin to reverse the course of this disaster. India is not a faraway problem. In pandemic time and distance, every place is nearby, it said.
Major Democratic fundraiser for the Biden’s presidential campaign Shekar Narasimhan urged the US President to speak to Prime Minister Narendra Modi. We have to do something in the face of a humanitarian disaster. Every friend I know in the US with family in India reports that relatives have died or been affected, he said.
President please speak to Prime Minister and see if we can lend 10M doses of AZ vaccine like tomorrow. We must help now! he said.
The government expressed confidence in the competence of Indian vaccine companies, their manufacturing capacity and global presence while stating in statement that "over 30 Indian vaccines are in different stages of development, with a few entering the trial stages."
Similarly, in drug development, three approaches are being taken. First, the repurposing of the existing drugs and at least four drugs are undergoing synthesis and examination in this category.
Secondly, the development of new candidate drugs and molecules are being driven by linking high performance computational approaches with laboratory verification.
Thirdly, plant extracts and products are being examined for general anti-viral properties.
In diagnosis and testing, several academic research institutions and startups have developed new tests, both for the RT-PCR approach and for antibody detection, said the government. In addition, by linking laboratories all over the country, capacity for both these kinds of tests has been enormously scaled up, the statement added.
Meanwhile, the problem of importing reagents for testing has been addressed by consortia of Indian startups and firms, meeting the current requirements. The government insisted that the current thrust also holds promise for the development of a robust long-term industry in this area.
The Prime Minister noted that the "extraordinary coming together" of academia, industry and government in a combined manner with speedy but efficient regulatory process in this hour of crisis when all entities need to work together.
Modi is believed to have told during the meeting that such coordination and speed should be embedded into a standard operating procedure.
Appreciating the scientific coming together of computer science, chemistry and biotechnology in drug discovery, Modi suggested that a hackathon be held on this subject, linking computer science to synthesis and testing in the laboratory.
The Prime Minister said that the successful candidates from the hackathon could be picked by the startups for further development and scaling up of their efforts.
"This kind of pride, originality and sense of purpose should dominate our approach going ahead," Modi is believed to have told those present in the meeting.
This stock-taking and secretion for a homegrown vaccine for Covid-19 come closely on the heels of Modi stressing on "self-sustenance" as the way forward in many of his addresses off late.
(IANS)
After comprehensive deliberation, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), chaired by Niti Aayog member (Health) Dr V.K. Paul, issued the Regulatory Pathway for Covid-19 vaccines approval for “restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL)”.
The decision has been taken amid an unprecedented surge in Covid cases in the country with over 2 lakh people were infected on a single day, claiming 1,73,123 lives so far.
The government on April 13, had approved a significant streamlining and fast tracking of regulatory system for these foreign produced vaccines.
This decision aimed at facilitating quicker access to such foreign vaccines by India to encourage imports including bulk drug material, optimal utilization of domestic fill and finish capacity, which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.
Considering the step, the Central Drugs Standards Control Organization (CDSCO) headed by Drugs Controller General of India (DCGI) on Thursday explained the pathway that include preparation for detailed guidelines for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
“These guidelines have since been prepared and posted by CDSCO on its website. The CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders,” the Ministry said.
Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO, said the Ministry, adding application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary).
The CDSCO will process such applications for restricted use in emergency situation and DCGI will consider and take a decision within three working days from date of submission of complete application by the applicant.
The DCGI will issue permission for restricted use in emergency situation with conditions like Vaccine shall be used as per the guidelines prescribed under national Covid-19 vaccination programme.
“First 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further vaccination program. Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.”
Applications for restricted use in emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license.
The CDSCO will process applications for registration certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and import license, within three working days from the date of approval of restricted use in emergency situation.
As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory (CDL), Kasauli before it can be used as per the guidelines prescribed under the national Covid-19 vaccination programme.
The applicant will use Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to the CDSCO, which will review it.
Once found satisfactory, the Ministry said, the CDSO will authorise the applicant to use the vaccine.
The CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within seven days of the receipt of the proposal.
“Applicant will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO. After the receipt of the bridging trial results, the DCGI will review the permission granted for restricted use in emergency situation.”
The move comes as over 11.44 crore Covid vaccine doses have been administered to the people in the countrywide vaccination drive started from January 16.
Presently, two “Made in India” vaccines have been approved for Emergency Use Authorisation (EUA) by national regulator DCGI. These are “Covishield”, developed by Oxford University-AstraZeneca and manufactured by Serum Institute of India (SII) and “Covaxin” developed and manufactured by Bharat Biotech International Ltd (BBIL).
On April 13, India also granted permission for third Covid-19 vaccine ‘Gam-COVID-Vac’ combined vector vaccine, popularly called Sputnik-V, in emergency situations.
The vaccine candidate, Ad26.COV2-S is currently undergoing clinical trials.
Aspen Pharmacare on Monday said it will perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson.
This agreement is still subject to the successful completion of the relevant technology transfer activities and finalisation of certain commercial manufacturing terms.
"We have been selected as a vaccine partner by Johnson & Johnson and this project will receive priority focus," said Stephen Saad, Aspen Group Chief Executive.
"We are particularly pleased to be given the opportunity of providing assistance for patients in need across the world from our South African base," Saad added.
Aspen Pharmacare said it has agreed to provide the necessary capacity required for the manufacture of Johnson & Johnson's Covid-19 vaccine candidate at its existing sterile facility at Port Elizabeth, South Africa.
Aspen has invested in excess of 3 billion rand (approximately $185 million) in the facility together with high technological equipment and systems used to manufacture sterile drugs and vaccines, packaged into vials, ampoules and pre-filled syringes.
The production area where it is intended that the vaccine candidates will be manufactured has the capacity to produce more than 300 million doses per annum, the company said.
(IANS)
Also Read: BE Signs Pact With Johnson & Johnson For Covid Vaccine Production
The money would go through the Covid-19 Vaccine Global Access (COVAX) Advance Market Commitment (AMC) mechanism, which will help support 92 low- and lower-middle-income countries' access through the COVAX Facility, said the statement.
The COVAX Facility is a global risk-sharing mechanism which seeks to procure, equitably allocate and deliver 2 billion doses of COVID-19 vaccines by the end of 2021.
Singapore is one of 97 self-financing participants in the Facility.
The contribution is part of "our consistent support for vaccine multilateralism, and the fair and equitable access and allocation of vaccines", said the statement.
The AMC eligible countries include several ASEAN countries as well as small states globally, it added.
The Covid-19 virus "does not respect borders, and no one is safe until everyone is safe", said the statement, adding that the successful development of safe and efficacious vaccines is a critical step towards overcoming the pandemic.
Ambassadors and High Commissioners of around 80 countries will be landing in the city on December 9 to visit Bharat Biotech and BE limited which are working on the COVID-19 vaccine.
An official release said on Friday Chief Secretary Somesh Kumar held a meeting with an advance team, including Chief of Protocol Nagesh Singh and other senior officials of the state government and discussed the arrangements to be made in connection with the high profile visit,.
"Chief Secretary informed that the dignitaries will be visiting Bharat Biotech Limited and Biological E limited the industrial units which are working on the COVID-19 vaccine in the country.
He asked the officials to make foolproof arrangements duly following all the COVID-19 protocols during the visit of the dignitaries," the release said.
As many as five well equipped buses and a special medical team, should be put in place for the envoys.
A presentation should also be made to showcase the states potential in the production and supply of vaccine and should also include the Pharma City and Genome Valley, he added.
The Ministry of External Affairs is organising the visit of Ambassadors and High Commissioners to familiarise the foreign envoys about some key research and development activities being done by the country, according to the release.
(With IANS Inputs)
Even though Odisha had conducted the dry run for Covid-19 vaccines in all districts on January 2, the question still remains if the State is actually ready to take up this gigantic task of vaccination.
While manpower will not be a bump for the State, given the hands-on experience it has from UIP (Universal Immunisation Programme), still the State will face a big test when the critical task of administering vaccine to a population of over 3.2 lakh is put into action.
The test is whether Odisha has the capacity at the level of ‘cold chain points’ to store the massive vaccine dispatches.
The Big Challenge
As vaccines are susceptible to temperature variations, storing of vaccines appropriately will not only preserve its efficacy but also minimises the wastage as the Centre has already coined the slogan of ‘One needle, One Syringe, One Vaccine’.
"Since the Covid-19 vaccines are to be stored at a temperature of 2 - 8 degrees Celsius, those will be kept in ILRs (Ice Lined Refrigerators). We have 1,222 Cold Chain Points (CCP) in our State, which are more than sufficient to carry out the Corona virus vaccination drive. However, the capacity of ILRs (Ice Lined refrigerators) in the CCPs need to be augmented. And the State health department has already initiated procurement of more ILRs for storing Covid-19 vaccines," informed Niranjan Mishra, Director, Public Health.
Space Matters
As per the data available with the National Health Mission (NHM), Odisha has currently over 1,796 ILRs for storing the vaccines under the Universal Immunisation Programme (UIP). The capacity of the ILRs in State stood at approximately 2.03 lakh litres, informed highly placed sources.
Sources further added that the Covid-19 vaccination is a different ball game as the target group is larger.
In the first phase of Covid-19 vaccination the shot will be given to all health workers across the State. An estimate shows that Odisha would need over 7 lakh doses for the Phase -I vaccination.
How many Extras Needed?
“Though no details have been played out as yet, we assume the packed vaccine volume per dose will be around 5ml. Accordingly, the storage volume of ILRs needed to store the over 7 lakh doses is estimated at around 3,500 litres. The State government has already requested the Centre to provide assistance for around 1000 ILRs,” explained a very senior health official while requesting anonymity. He informed that the procurement process has been initiated and “We don’t see any glitch whatsoever in storing the Covid-19 vaccines.”
Cold Chain White Paper
A reality check of cold chain equipment in Odisha reveals the following:
“Odisha has asked the Centre to provide over a dozen of walk-in freezers for safe transportation of the vaccines. We also need nearly 500 deep freezers. However, augmenting will not prove a hurdle in Covid-19 vaccination drive,” opined the senior official.
Key Players’ Info
ILR: Is known as ice lined refrigerators. This equipment is used to store vaccines at the PHC (Primary Health Care) level. It maintains a temperature of 2-8 deg C. The equipment can maintain the temperature range for 24-hours with only 8 hours of power supply. It can store 63 -160 vaccine packs.
Deep Freezers: This equipment has the capacity to maintain a temperature range of (-)18 to (-)28 deg C. It has been designed in such a way that the equipment can maintain the temperature range even in the event of power failure.
The vaccinations were administered on Saturday by a household doctor at the Windsor Castle where the royal couple have been staying since early last year, Xinhua news agency quoted British media reports as saying citing a source.
The source added the Queen decided to let it be known she had the vaccination to prevent further speculation.
The Queen, 94, and Prince Philip, 99, are among around 1.5 million people in the UK to have had at least one dose of the Covid-19 vaccine so far.
People aged over 80 in the country are among the high-priority groups who are being given the vaccine first.
It has not been disclosed which of the vaccines the royal couple received.
On Friday, a third coronavirus vaccine was approved for use in the country, as the UK recorded the highest number of coronavirus deaths, as well as the highest daily increase of cases.
As of Sunday morning, the overall Covid-19 cases and deaths in the UK stood at 3,026,313 and 81,000, respectively.
(IANS)
According to the order, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10 it would cost Rs 210.
The HLL Lifecare Limited, a public sector undertaking, issued the supply order on behalf of the Union Health Ministry in the name of Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII).
The Covishield vaccine doses would be initially shipped to 60 consignment points from where those would be distributed further, the sources said.
The health ministry is also likely to soon sign a purchase order for another anti-coronavirus vaccine, Covaxin, which has been indigenously developed by Bharat Biotech. Meetings for this was underway, a source said.
India had recently granted emergency use authorisation to two vaccines, Oxford's Covishield being manufactured by Serum Institute in India and Bharat Biotech's Covaxin. Both vaccines, according to a statement from the Health Ministry, have established safety and immunogenicity.
The country India launch its COVID-19 vaccination drive from January 16 in what Prime Minister Narendra Modi has called the world's largest inoculation programme with priority to be given to nearly three crore healthcare and frontline workers.
After vaccinating healthcare and frontline workers, priority will be given to those above 50 years of age and the under-50 population groups with co-morbidities, together numbering around 27 crore.
Prime Minister Narendra Modi on Monday emphasised that India is entering into a decisive battle against Covid-19, as the country prepares for the Made in India vaccination drive from January 16.
Making the closing remarks at the meeting with the Chief Ministers on Covid vaccine roll-out, the Prime Minister said that the public representatives are not in the priority list and the first round of vaccines will be given to the frontline workers. He also said that the state governments will not have to pay for the first round of Covid vaccines as the Centre will bear the cost.
"We have to continue creating public awarreness, but the maximum awarreness is required after the second and third round when we complete three crore vaccinations," Modisaid.
"Public representatives are not in the priority list. Only the frontline and healthcare workers are on the list. The fight against coronavirus is an example of India's federalism," the Prime MInister said.
"India is entering into a decisive battle against Covid-19 and we should not let our guard down now. We are going to start the vaccination drive from January 16. It is a matter of pride for us that the two approved vaccines for Covid-19 are both Made in India," Modi said.
The Prime MInister said that both the Indian vaccines are more cost effective than any other vaccine in the world.
"Apart from the two already approved vaccines, four others are in the pipeline. It will help us plan for the future in a better way. Our experts have taken all precautions to provide the countrymen with effective vaccines," Modi said.
The Prime MInister said that these vaccines are made keeping in mind the situation of the country. "In the second phase, people above 50 years of age will be vaccinated," Modi said.
Speaking at the interaction with CMs on vaccination rollout. https://t.co/gbWZ4LsQGB
— Narendra Modi (@narendramodi) January 11, 2021
(With Agency Inputs)
"As many as 110 lakh (1.1 crore) doses of Covishield vaccine are being procured from the Serum Institute of India at a cost of Rs 200 per dose, excluding taxes. A total of 55 lakh doses of Covaxin vaccine are being procured from Bharat Biotech," Union Health Secretary Rajesh Bhushan said during a press conference.
The cost of 38.5 lakh doses of Covaxin is Rs 295 per dose, excluding taxes. Bharat Biotech is providing 16.5 lakh doses of Covaxin free of cost to the Central government. Hence, the cost of Covaxin comes to Rs 206 per dose," he added.
Vaccines have already reached some states. Till 4 p.m., about 54,72,000 doses were received by the states and Union Territories. By January 14, 100 per cent doses will be received.
The much-awaited Covid-19 vaccination drive will kick-off on January 16. The Central government plans to vaccinate nearly 30 crore people in the first phase of the drive. Priority will be given to the healthcare and frontline workers who are estimated to be around three crore, followed by those above 50 years of age and the under-50 population with comorbidities numbering around 27 crore.
On January 3, two vaccines -- Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India -- were approved for 'restricted emergency use'. Few more vaccines are in the pipeline and are conducting trials.
(With IANS Inputs)
The Indian embassy in Rabat tweeted: "In a manifestation of excellent relationship between India and Morocco, the first consignment of COVID-19 vaccine developed by AstraZeneca and Oxford University and produced by Serum Institute of India, the world's largest vaccine producer was shipped from India for Morocco today." The embassy later replied to its own tweet, saying: "AffordableVaccine4All."
Earlier this week, Minister for External Affairs, S Jaishankar had met the ambassadors of African countries. He tweeted: "Our conversation covered COVID recovery, vaccines, air travel, and digital experiences. Also spoke about India's current priorities & challenges. Assured them of India's interest in an early IAFS (India-Africa Forum Summit) Summit."
Jaishankar hinted that his talks with the African envoys did touch vaccines and path to recovery. African countries including multilateral agencies are worried over vaccine hoarding by the developed world. Canada has hoarded enough vaccines to give five jabs per person. Other Western countries too have reserved or pre-booked more vaccines with manufacturers than they require. Stockpiling of vaccines has led to concern that poorer nations may not be able to fend for their citizens - ironically, prolonging the existence of the virus, thereby keeping everyone vulnerable to the infection.
World Health Organization Director-General Tedros Adhanom Ghebreyesus hit out over "vaccine inequity," saying this could amount to a "catastrophic moral failure" on a global scale. The US, Canada, the UK and most European countries are into their second month of mass vaccination even as the lower-income countries fret about protecting their people with no vaccine supply on the horizon.
A number of statements by high ranking Indian officials indicate that the country plans to support African countries in their battle against an unpredictable pandemic.
Union Health Minister Dr Harsh Vardhan addressed that concern. Dr Vardhan reassured the WHO's executive board session this Monday that India remains committed to "equitable distribution of vaccines." He added that vaccines have brought a ray of hope and now governments across the world have to ensure that the ray of hope reaches everyone.
Barely a fortnight back, Foreign Secretary Harsh Vardhan Shringla told the United Nations Security Council (UNSC) that India would continue to support African countries and empower Africa on the principles of "inclusivity, sustainability, transparency and socio-economic development with dignity and respect." Shringla was referring to the debt-trap that many African countries find themselves in owing to 'concessional loans' from China. He also highlighted supplying critical medicines to African countries during the Covid crisis.
Prime Minister Narendra Modi reiterated at least twice this month that India will help the world meet its healthcare needs. On Wednesday, Modi tweeted: "India is deeply honoured to be a long-trusted partner in meeting the healthcare needs of the global community. Supplies of Covid vaccines to several countries will commence tomorrow, and more will follow in the days ahead."
For Africa, the current situation is a throwback to the HIV/AIDS epidemic that ravaged nations due to prohibitive costs of drugs. Eventually, high-quality but inexpensive generics from India saved the day for the continent - massively bringing down the cost of treatment and helping nations beat back AIDS. Indian medicines proved effective in a situation where the West failed.
As the vaccine factory of the world, with a dependable pharmaceutical base, India is at the forefront in helping the world combat the pandemic. Last year, India had provided hydroxychloroquine and paracetamol tablets to over 100 countries including the US in the early stages of coronavirus - when information was still in its infancy.
With the vaccines giving hope to governments and to people, India has stepped up its "vaccine diplomacy." The supply of the much-sought after vaccines to Morocco could be India's first step towards addressing the "vaccine inequity" for Africa, even as it manages its own ambitious vaccination programme.
A Poseidon 8I aircraft of the Indian Navy transported 100,000 doses of coronavirus vaccines to Mauritius and 50,000 doses to Seychelles as part of India's grants assistance, officials said on Saturday.
Both the countries were delivered the consignments on Friday.
First the aircraft flew to Seychelles and after delivering the consignments to the island nation, it travelled to Mauritius.
"The Indian crew, led by Captain Rahul Mehta, was accorded a warm welcome by diplomats from Seychelles, members of the Indian High Commission and medical crew who received the vaccine shipment at Seychelles international airport," an official said.
The Indian crew was also accorded a warm welcome by a number of top ministers at the Mauritius International airport.
The Poseidon 8I is a maritime reconnaissance and anti-submarine warfare aircraft.
So far, India has sent consignments of coronavirus vaccines under grant assistance to Bhutan, Maldives, Nepal, Bangladesh, Myanmar, Mauritius and Seychelles.
On Friday, India began commercial exports and sent two million doses each to Brazil and Morocco.
India is also sending coronavirus vaccines as commercial supplies to Saudi Arabia, South Africa, Bangladesh and Myanmar.
In a major announcement, India on Tuesday had said it will send COVID-19 vaccines under grant assistance to Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles from Wednesday and supplies to Sri Lanka, Afghanistan and Mauritius will commence after confirmation of necessary regulatory clearances.
India is one of the world's biggest drugmakers, and an increasing number of countries have already approached it for procuring the coronavirus vaccines.
India has already rolled out a massive coronavirus vaccination drive under which two vaccines, Covishield and Covaxin, are being administered to frontline health workers across the country.
While Oxford-AstraZeneca's Covishield is being manufactured by the Serum Institute, Covaxin is being produced by Bharat Biotech.
India had earlier supplied hydroxychloroquine, Remdesivir and paracetamol tablets, as well as diagnostic kits, ventilators, masks, gloves and other medical supplies to a large number of countries to help them deal with the pandemic.
(With Agency Inputs)
At a time when several countries, including India, have started the Covid vaccination drive, cancer patients, one of the vulnerable groups, are waiting to hear if they can also take the jab.
Doctors said that this can be done only with safe and effective vaccines along with the coordinated global vaccination programme.
Of more than 200 vaccines being developed across the world, three are being indigenously produced in India. Though all these vaccines are aimed at providing immunity against the SARS-CoV2 infection, the presentation of antigens to the host for the development of antibodies relies on various technologies or platforms.
The efficacy of Covid-19 vaccines can also vary in patients with distinct contexts of malignant disease (tumour type, disease extent, intrinsic or therapy-induced immune suppression). According to doctors, benefits of vaccination seem to outweigh the risks.
"The efficacy and duration of immunity in patients with cancer are still unknown and unexplored. Given the often-immune compromised status and the frailty of cancer patients, it is suggested to monitor in the context of registries and dedicated clinical trials. Close surveillance and monitoring of patients with cancer is required after Covid-19 vaccination to assess the potential adverse events and measure clinical outcomes like infection, severity and mortality from Covid-19, complications from cancer etc.," Ajay Chanakya Vallabhaneni, Consultant Surgical Oncologist and Robotic Surgeon, KIMS Hospitals, told IANS.
"Patients with cancer are particularly vulnerable to Covid-19 because of the immune compromising nature of cancer treatment. On top of that, progressing cancer itself depletes the immune system and leaves patients susceptible to infection. Admittedly, very few patients with active cancer or in active therapy were included in the trials. But assessment of studies available on vaccines, these look remarkably safe for cancer patients too," said Revanth Gangasani Reddy, Consultant Surgical Oncology, Aware Global Hospitals.
According to A.V.S. Suresh, Senior Consultant Medical Oncologist and Haematologist, Continental Hospitals, although evidence regarding vaccination in patients with cancer is limited, there is enough proof to support anti-infective vaccination in general (excluding live-attenuated vaccines and replication-competent vector vaccines), even in patients with cancer undergoing immunosuppressive therapy. Most traditional vaccines contain dead or disabled viruses, which are incapacitated to cause disease while provoking an immune response against the virus.
"Cancer cells progressing in a human body weakens the immune system and makes the patient vulnerable to infections like the Covid-19 virus. People living with HIV too have low CD4 count and high viral load are at high risk of infection. It is important that people with cancer and HIV are given priority and are vaccinated at the earliest. The government and the healthcare mechanisms should create a system where Covid-19 vaccine is administered on such highly susceptible cases on an urgent basis," said D. Sridhar, Consultant Surgical Oncology, SLG Hospitals.
The doctors are of the view that the timing of vaccination depends on individual therapy scenarios and may ideally occur before systemic therapy starts. But if the patient has already started systemic therapy, it is reasonable to vaccinate him/her during therapy.
Physical distancing measures, masks, face shields, sanitisers and other hygiene measures are still required during the pandemic, including for patients with cancer, and should certainly accompany the vaccination strategies.
"Some are in Phase I, some in Phase II, and a few approaching Phase III of the clinical trials. We are elated to have a huge portfolio in the near future," he said at a press conference here.
The Minister said that the Department of Biotechnology had been provided a budget of Rs 900 crore for the development of potential vaccines against Covid-19.
"The money has been kept aside for the department for use in research and development of potential vaccine candidates against the viral disease," he added.
Vardhan also said that the Union government will begin vaccination drive for around 27 crore Indians above the age of 50 three weeks from now.
"Three weeks from now, the government will start giving doses of coronavirus vaccines to 27 crore persons above the age of 50," he said.
An expert group on vaccination will discuss how to pay for the doses for those above 50, he added.
The vaccination for frontline workers began earlier this month.
On the private healthcare sector's role in the vaccination process, he said that such facilities and workers were already a part of the drive.
"During emergency use authorisations (EUA), it is the government's responsibility to keep things under control; open market sales are not part of the EUA," he added.
Meanwhile, the Minister reviewed the Covid-19 situation in the country. He said that no new cases of COVID-19 have been reported in 188 districts of the country in the past seven days.
Vardhan emphasised the importance of social distance and appropriate healthcare behaviour amid the pandemic despite falling number of corona cases in the country.
"It is crucial that people continue to follow COVID-appropriate behaviour which I had called a social vaccine, along with the real vaccine," he quipped.
Meanwhile, the Health Ministry said that a new flagship programme -- Prime Minister Atmanirbhar Swastha Bharat Yojana -- has been announced in the Union Budget 2021-22. "The Budget refers to a holistic approach toward health and healthcare. Allocation to the health sector for 2020-21 is 1.8 per cent of the Gross Domestic Product," the Ministry added.
The Union government has prioritised vaccination of 30 crore Indians, dividing them into three categories -- one crore healthcare workers, 2 crore frontline workers, and 27 crore general populace above the age of 50.
On January 3, the Drugs Controller General of India had approved 'Covishield' vaccine developed by Pune-based Serum Institute of India and 'Covaxin' of Bharat Biotech for emergency use authorisation in the country.
Both vaccines have been provided in the nationwide immunisation drive, that was kicked off on January 16. Till Sunday, more than 8 million (82,85,295) doses of vaccines had been administered across India.
Meanwhile the Ministry of Health and Family Welfare said, nearly one lakh persons have received second doses of coronavirus vaccines in India so far and thus been fully immunised against Covid-19, whereas 2,31,476 more beneficiaries received the vaccine doses on Monday.
The vaccination drive was conducted on Monday in all states and Union Territories, taking the cumulative vaccination figures to 85,16,285 in the country. Of these, 61,54,385 are healthcare workers and 23,61,491 frontline workers.
Uttar Pradesh led with 52,666 inoculations, followed by Jammu and Kashmir (17,820), West Bengal (15,169), Karnataka (14,716), Maharashtra (13,762), Guajarat (13,137), Chhattisgarh (11,863), Jharkhand (11,618), Tamil Nadu (10,708), and Madhya Pradesh (10,114).
The vaccination of healthcare workers started on January 16 and frontline workers on February 2.
The administration of second doses began with a poor response on Saturday, wherein only 7,688 persons who were administered the initial doses turned up to receive the second shots. It is only 4 per cent of 1,91,181 healthcare workers inoculated on the first day of the nationwide immunisation drive on January 16.
He also said that 1.84 crore COVID-19 vaccine doses have been administered to people so far, while 23 crore tests have been conducted.
"India has developed two vaccines, which have been given to 71 countries. Many more nations are seeking the vaccines, and these are not little-known nations...Canada, Brazil and other developed countries are using Indian vaccines with a great zeal," he said.
"More than half a dozen vaccines are going to come up," he said.
"Till Saturday morning, 1.84 crore vaccine shots have been given in the country and 20 lakh people were inoculated yesterday," the minister added.
He was speaking while inaugurating the new green campus of the National Institute of Research in Environmental Health near here.
Prime Minister Narendra Modi wants to create a new India to turn it into a 'vishwa guru' (world leader), he added.
"Respect science. There is a need to end politics over it (vaccine) given that it is a scientific fight not a political one. That is why we should work unitedly," Vardhan said.
The efforts of our scientists are praiseworthy as due to their labour we have achieved all this. Year 2020, apart from being a COVID-19 year, will be remembered as the year of science and scientists, he added.
He said that initially there was only one laboratory in India for COVID-19 testing. "But we have 2,412 testing facilities now," he added.
"We were the first in the world to isolate the coronavirus. We isolated its mutation. And our scientists helped the ICMR in vaccine. People have praised it (vaccine).
Some people tried to create confusion, but truth is unbeatable," he said.
Talking about the rising infection cases, the minister said this "disturbing trend" was due to the carelessness and misunderstanding.
"People think that as the vaccine has come and all is well now," he said, while urging them to follow the COVID-19 rules for protection against the virus.
"For the purpose of resuming people-to-people exchanges in an orderly manner, starting from 15 March, 2021, the Chinese Embassies and Consulates in India will provide the persons having taken Chinese-made COVID-19 vaccine and holding the Certificates of Vaccination," a notice posted on the Chinese Embassy in New Delhi said.
The announcement makes little difference for thousands of Indian students besides professionals working in China and their family members who are stuck in India awaiting Beijing to permit their return as there are no Chinese vaccines available in India.
The Chinese Embassy notice did not specify how Indians can access the Chinese-made vaccines in India as they are not available in the country.
Over 23,000 Indian students, most of them medical students, besides hundreds of professionals working in China are stuck in India since last year due to coronavirus travel restrictions.
Despite repeated representations from the Indian embassy and appeals by the students, China is yet to respond positively.
State-run Global Times reported that such notices were put up by Chinese embassies in 20 countries.
Asked about the rationale of the regulation to have Chinese vaccines in countries like India where China made vaccines are not available, Chinese Foreign Ministry spokesman Zhao Lijian told a media briefing here on Tuesday that many countries have floated the idea of linking vaccination status with opening up international travels.
"Our proposal to facilitate the travel of those who have been inoculated with Chinese vaccines is made after thoroughly considering the safety and efficacy of Chinese vaccines," he said.
"We believe this is a meaningful exploration of facilitating international travel once mass vaccination has been achieved. It is not linked to the recognition of Chinese vaccines," he said.
When pointed out that would it not be better if China recognised the vaccines endorsed by WHO, which is yet to approve the Chinese vaccines, Zhao said, "China's proposal is a meaningful step. We are trying to facilitate international travel".
"This is an arrangement made by the Chinese side unilaterally. It is a different thing from vaccine recognition," he said.
The WHO has already approved Pfizer, Moderna and AstraZeneca vaccines. AstraZeneca vaccine is being produced by Serum Institute in Pune in the name of Covishield.