WASHINGTON: A panel of outside advisers to the U.S. Food and Drug Administration on Thursday (Dec. 17) strongly supported the emergency use of the Moderna coronavirus vaccine, virtually ensuring a second option for protection against COVID-19 for a country devastated by a pandemic.
The committee voted 20-0 by one voter that the benefits of the vaccine outweigh its risks in people aged 18 and over, a week after the same panel backed a vaccine similar to Pfizer and German partner BioNTech, leading to FDA (EUA) emergency use approval a day later.
The FDA is expected to approve the EUA as early as late Thursday or Friday, giving another hope to a country that has lost more than 300,000 lives to COVID-19 – including a one-day high of 3,580 death Wednesday – while on record numbers of patients are threatening to get over U.S. hospitals and health care workers.
“Going from getting a (genetic) set of virus in January to getting two vaccines in December is a remarkable achievement,” said Dr James Hildreth, chief executive of Meharry College, which voted to recommend the vaccine for emergency use.
The same stop came from Dr Michael Kurilla, who works at the National Institutes of Health and who felt that blanket approval for those aged 18 and over was too broad.
“I’m not sure the benefits for these age groups outweigh the risk. And I wish it were more targeted at people who are at high risk for a dangerous COVID infection. and life threatening, “he said.
The Moderna vaccine is expected to begin being released as soon as the FDA gives the green light. Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses have been given for states and cities and were ready for rollout across the country.
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Vaccines are not a panacea, however, as they take months to be introduced into a country where the virus suddenly runs and there are public health measures such as social distance and wearing a mask. rejected by large sections of the population.
EASIER TO TRANSPORT AND STORAGE
Unlike the Pfizer vaccine, which comes with complex diffusion challenges due to the need to be removed and stored at -70 degrees Celsius, the Moderna vaccine does not require specialized ultra-cold freezers or large volumes of dry ice. , making it easier to provide rural and remote provision. areas.
U.S. officials have said they expect to have 40 million doses of the Pfizer / BioNTech and Moderna vaccines by the end of the year – enough to protect 20 million people. Both vaccines were approximately 95 percent effective in preventing illness in significant clinical trials without adverse safety issues.
The first wave of doses is expected to be identified for health care workers treating COVID-19 patients and vulnerable residents and nursing home staff.
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Documents prepared by FDA scientists and released prior to the meeting stated that a two-dose schedule of the Moderna vaccine was highly effective in preventing COVID-19 and did not raise specific safety issues. any.
Perhaps even more importantly, as hospital intensive care units are filling up to capacity across the country, cases of COVID-19 malignancy were not among those vaccinated in the trial versus 30 such cases in the placebo group.
The vaccine, based on the new technology of synthetic messenger RNA (mRNA), is administered in two strokes approximately 28 days apart. The Pfizer-BioNTech image is also an mRNA vaccine.
The United States in August entered into a $ 1.5 billion U.S. deal with Moderna to receive 100 million doses of the vaccine.
Around 20 million doses are expected to be delivered this month, with the rest of the first purchase coming in the first quarter of next year. Last week, Moderna agreed to deliver an additional 100 million doses in the second quarter.
In the global race to launch highly effective vaccines against the coronavirus that appeared in central China late last year, the Massachusetts-based biotechnology company has reached the finish line on ahead of some much bigger competitors such as AstraZeneca and Johnson & Johnson.
An emergency meeting of the advisory panel of the U.S. Centers for Disease Control and Prevention is expected to follow the FDA’s approval for the Moderna vaccine with its official recommendation for use by the U.S. public.
After that, state and local public health authorities will begin administering the first dose.
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