"We believe our mRNA platform can solve the world's greatest health challenges, from diseases impacting millions to ultra-rare diseases impacting dozens, to medicines personalised down to the individual level," CEO Stephane Bancel said.
"Today we are announcing the first step in our novel respiratory vaccine programme with the development of a single-dose vaccine that combines a booster against Covid-19 and a booster against flu," she added.
The combination vaccine mRNA-1073 encodes for the Covid-19 spike protein and the flu hemagglutinin glycoproteins.
Moderna is developing vaccines against viral diseases including vaccines against acute respiratory infections, vaccines against persistent infections, as well as vaccines against threats to global public health.
"We are making progress on enrolling patients in our rare disease programmes, and we are fully enrolled in our personalised cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines," Bancel said.
The US drugmaker has, last week, applied to the US Food and Drug Administration (FDA) for the evaluation of a booster dose of its mRNA-based Covid-19 vaccine.
Early trials have shown that the mRNA-1273 booster shot at 50 microgram dose level induced robust antibody responses of more than 40 times against the highly infectious Delta variant (B.1.617.2), the company has said.
The US regulatory body had authorised the emergency use of Moderna's Covid-19 vaccine in individuals 18 years of age or older in December 2020. It has received emergency authorisation for use of its Covid-19 vaccine in adults from health agencies in more than 50 countries.
The Moderna Covid-19 vaccine is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein.
In the trial, Moderna tested a 50-microgram dose of three vaccine booster candidates in previously vaccinated individuals.
The findings showed that it induced robust antibody responses against the wildtype D614G Covid-19 strain and against important variants of concern including Gamma (P1); Beta (B1351); and Delta (B16172), the US pharmaceutical major said in a statement.
"Neutralising antibody levels following the boost approached those observed after primary vaccination with two doses of 100 microgram of mRNA-1273," it added. The data has been submitted to a peer-reviewed journal for publication.
The company added that its Covid-19 vaccine does not wane away and remains durable through six months after the second dose. The result of its clinical trial, which started in late July 2020 and recruited 30,000 volunteers, showing 94.1 per cent efficacy did not change much after six months, the company said in a statement.
"We are pleased that our Covid-19 vaccine is showing durable efficacy of 93 per cent through six months, but recognise that the Delta variant is a significant new threat so we must remain vigilant," Moderna CEO Stephane Bancel said.
Moderna has also filed to the US Food and Drug Administration for a final approval of its vaccine on June 1, and expects to complete its submission in August.
The company is also conducting clinical trials of mRNA candidates in across five therapeutic areas including infectious diseases, cardiovascular, oncology, rare disease, and autoimmune disorder.
"We have begun preparing late stage studies for our flu vaccine and RSV vaccine, which received fast track designation from the FDA a few days ago and are looking forward towards our vision of a single dose annual booster that provides protection against Covid-19, flu and RSV for adults," Bancel said.
On Thursday, the company also released its second-quarter earnings report. Moderna's Covid vaccine generated $4.2 billion in sales in the three months ended June 30, the earnings report said.
Moderna said it aims to produce between 800 million to 1 billion Covid vaccine doses this year. It has also signed vaccine contracts worth $20 billion in sales this year and has agreements worth $12 billion in 2022, the statement said.
The Phase 2 trial showed that antibodies produced by a single 50 mg dose of its booster shot was effective against the original form of the virus, as well as against two variants of concern first identified in South Africa (B1351) and Brazil (P1).
“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants,” said Stephane Bancel, Chief Executive Officer of Moderna, in the statement.
The pharma major’s specifically designed second shot against the South Africa variant, showed even stronger immune response. The preliminary results have been described preprint in bioRxiv, the company said.
“Our mRNA platform allows for rapid design of vaccine candidates that incorporate key virus mutations, potentially allowing for faster development of future alternative variant-matched vaccines should they be needed. We will continue to make as many updates to our Covid-19 vaccine as necessary to control the pandemic,” Bancel added.
For the trial, the company involved 40 participants, and they were administered the third shot six to eight months after taking the currently given two-shots.
Antibodies from the initial vaccination were detectable in 37 of those people, but in about half the participants, the antibodies performed poorly against the variants that have pummeled South Africa and Brazil. The boosters raised the levels of the antibodies against both variants, although the boosters were still slightly less effective than against the original form of the virus, the New York Times reported.
Pfizer also recently announced that Covid vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated.
The mRNA platform used in the Pfizer and Moderna vaccines can be readily tweaked, enabling the companies to produce newer versions within weeks.
Moderna began modifying its vaccine to combat the variant identified in South Africa, after reports emerged that the existing vaccines are slightly less effective against that variant. The variant carries a mutation that helps the virus sidestep the immune system, the report said.
Moderna is testing three strategies for enhancing the immunity produced by the current vaccine: using the current vaccine as a booster; using the booster designed specifically to combat B1351; and a combination of the two in a single vaccine, the report said.
Two doses of an experimental vaccine known as mRNA-1273 induced robust immune responses and rapidly controlled the Covid-19 in the upper and lower airways of Monkeys exposed to SARS-CoV-2, the National Institute of Allergy and Infectious Diseases (NIAID) reported.
In this study, published in the New England Journal of Medicine, three groups of eight rhesus macaques (monkeys) received two injections of 10 or 100 micrograms of mRNA-1273 or a placebo.
Injections were spaced 28 days apart. Vaccinated monkeys produced high levels of neutralizing antibodies directed at the surface spike protein used by SARS-CoV-2 to attach to and enter cells.
"Notably, animals receiving the 10-micrograms or 100-micrograms dose vaccine candidate produced neutralizing antibodies in the blood at levels well above those found in people who recovered from Covid-19," the researchers wrote.
The experimental vaccine also induced Th1 T-cell responses but not Th2 responses, they added.
According to the study, induction of Th2 responses has been associated with a phenomenon called vaccine-associated enhancement of respiratory disease (VAERD).
Vaccine-induced Th1 responses have not been associated with VAERD for other respiratory diseases.
In addition, the experimental vaccine-induced T follicular helper T-cell responses that may have contributed to the robust antibody response.
Four weeks after the second injection, all the monkeys were exposed to SARS-CoV-2 via both the nose and the lungs.
Remarkably, after two days, no replicating virus was detectable in the lungs of seven out of eight of the monkeys in both vaccinated groups, while all eight placebo-injected animals continued to have to replicate virus in the lung.
Moreover, none of the eight monkeys vaccinated with 100 micrograms of mRNA-1273 had detectable virus in their noses two days after virus exposure.
This is the first time an experimental Covid-19 vaccine tested in nonhuman primates has been shown to produce such rapid viral control in the upper airway, the investigators noted.
"A Covid-19 vaccine that reduces viral replication in the lungs would limit disease in the individual while reducing shedding in the upper airway would potentially lessen the transmission of SARS-CoV-2 and consequently reduce the spread of disease," they added.
Meanwhile, Moderna has also begun a phase-3 clinical trial to evaluate mRNA-1273 vaccine, designed to protect against Covid-19 virus, which includes 30,000 participants the US clinical research sites, who do not have Covid-19.
(IANS)
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With the previous award of up to $955 million for the development of the vaccine to licensure, the new announcement brings the US government's commitments for early access to mRNA-1273 to up to $2.48 billion, Moderna said on Tuesday.
Under the terms of the agreement, the US government will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna.
The US government has announced that consistent with its commitment to free access to Covid-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself.
As is customary with all government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
"We appreciate the confidence of the US government in our mRNA vaccine platform and the continued support," Stephane Bancel, Moderna's Chief Executive Officer, said in a statement.
A Phase 3 study of mRNA-1273, being conducted in collaboration with the US National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), began on July 27.
BARDA is part of the office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS).
Enrollment for the study is on track to complete in September, Moderna said.
(IANS)
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The research, published in the Journal of Allergy and Clinical Immunology: In Practice, summarised what is currently known about allergic reactions to vaccines like those developed against COVID-19.
In the study, a team of experts led by allergists at Massachusetts General Hospital (MGH) in the US, proposed detailed advice so that individuals with different allergy histories can safely receive their COVID-19 vaccine.
After closer review of the data related to allergic reactions, the US FDA recommended that the mRNA vaccines, based on the genetic material of the novel coronavirus, be withheld only from individuals with a history of severe allergic reactions to any component of the COVID-19 vaccine.
The US Centers for Disease Control and Prevention also advised that all patients be observed for 15 minutes post-vaccination by staff who can identify and manage such reactions.
In the review research, Aleena Banerji, MD, clinical director of the Allergy and Clinical Immunology Unit at MGH and her colleagues outlined steps on safely receiving the second dose in individuals who develop a reaction to the first dose of COVID-19 vaccine.
"Our guidelines are built upon the recommendations of US regulatory agencies and provide clear steps to the medical community on how to safely administer both doses of the vaccine in individuals with allergic histories," Banerji said.
According to the experts, allergic reactions to vaccines are rare, with a rate of about 1.3 per 1 million people.
They said the mRNA vaccines developed by Pfizer-BioNTech and Moderna will have a similarly low rate of occurrence of allergic reactions.
The researchers recommend that individuals with a history of anaphylaxis to an injectable drug, or vaccines containing polyethylene glycol or polysorbate speak with their allergists before being vaccinated.
Banerji and her co-authors also suggested that vaccine clinics monitor all patients for 15 to 30 minutes to manage any allergic reactions that occur.
They said even patients with severe allergies to foods, oral drugs, latex, or venom can safely receive the COVID-19 vaccines.
(With PTI Inputs)
Vaccination with the Moderna Covid-19 Vaccine produced neutralising titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and South Africa, respectively, the company said on the basis of a study.
However, the company also said it will test an additional booster dose of its Covid-19 vaccine (mRNA-1273) to study the ability to further increase neutralising titers against emerging strains beyond the existing primary vaccination series.
Second, the company is advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in South Africa.
The company is advancing mRNA-1273.351 into preclinical studies and a Phase 1 study in the US to evaluate the immunological benefit of boosting with strain-specific spike proteins.
Moderna expects that its mRNA-based booster vaccine (whether mRNA-1273 or mRNA-1273.351) will be able to further boost neutralising titers in combination with all of the leading vaccine candidates.
"As we seek to defeat the Covid-19 virus, which has created a worldwide pandemic, we believe it is imperative to be proactive as the virus evolves. We are encouraged by these new data, which reinforce our confidence that the Moderna Covid-19 vaccine should be protective against these newly detected variants," Stephane Bancel, Chief Executive Officer of Moderna, said in a statement.
"Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective to boost titers against this and potentially future variants."
(IANS)