FDA chief says they have taken another crucial step in the fight against this global pandemic
Washington:
The United States authorized Moderna’s Covid-19 vaccine for emergency use on Friday, paving the way for six million doses of a second vaccine to begin shipping soon in the worst-affected country in the world.
The head of the Food and Drug Administration (FDA), Stephen Hahn, said: “With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic.”
“Congratulations, the Moderna vaccine is now available!” President Donald Trump tweeted.
The United States is the first nation to authorize Moderna’s two-dose regimen, now the second vaccine to be implemented in a Western country after the first, developed by Pfizer and BioNTech.
Congratulations, the Moderna vaccine is now available!
– Donald J. Trump (@realDonaldTrump) December 19, 2020
The Pfizer-BioNTech vaccine was approved by Britain on December 2, followed by several other countries, including the United States, last week. Less screened vaccines have also been implemented in China and Russia.
Meharry Medical College President James Hildreth, who was part of an expert panel convened by the FDA to discuss approval issues, said Thursday that it was a “remarkable achievement” to have developed and licensed the Pfizer and Moderna vaccines in the space. one year.
Together, they offer a ray of light at the end of the long tunnel of the pandemic.
The United States alone has seen more than 310,000 people die from coronavirus infections and is in the midst of a brutal winter surge, with nearly 115,000 people hospitalized, according to the Covid Tracking Project.
Millions of doses will begin shipping starting this weekend from cold storage sites outside of Memphis and Louisville, overseen by logistics company McKesson.
From there, they will be shipped to sites across the country through partnerships with FedEx and UPS.
– Cutting edge technology –
Moderna has several other drugs in development, but I’ve never seen any licensed before.
The decade-old Massachusetts-based biotech company received $ 2.5 billion in federal funding for its efforts and jointly developed the vaccine with scientists from the National Institutes of Health.
Both the Pfizer and Moderna vaccines are based on state-of-the-art mRNA (messenger ribonucleic acid) technology, and both have been shown to be highly effective, protecting about 95 percent of people against Covid-19 compared to a placebo.
They have also been found to have no serious safety concerns in clinical trials involving tens of thousands of people each.
The most commonly reported side effects were injection site pain, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. .
But now there have been a handful of people around the world who developed significant allergic reactions after receiving the Pfizer vaccine, and the FDA has said it will remain vigilant in their monitoring.
Both vaccines come with warnings for people who have a history of allergic reactions to their ingredients to avoid them.
The FDA will also be watching to see if, in extremely rare cases, both vaccines may be linked to Bell’s palsy, a relatively mild and temporary facial paralysis condition.
There were a handful of these cases in clinical trials, but not enough to attribute causation.
The FDA said that immunosuppressed people can have a lowered immune reaction and said there was insufficient data to say whether there were any particular risks associated with giving the vaccine to pregnant people.
– Placebo dilemma –
Both vaccines work by giving human cells the instructions to produce a coronavirus surface protein, which simulates an infection and trains the immune system for when it encounters the real virus.
Each of them differs in the formulation of the fat particles used to deliver the mRNA, allowing Moderna’s vaccine to be kept in long-term storage at -20 degrees Celsius, unlike Pfizer’s, which must be stored at -90 degrees Celsius.
Moderna conducted a clinical trial of more than 30,000 people, about half of whom received the product and the other half a placebo, with neither the recipients nor their healthcare providers knowing who was in which group.
He has proposed “unmasking” the entire study and offering the vaccine to placebo recipients, a plan criticized by some experts who say scientists will be deprived of valuable data and some people will end up receiving the vaccine earlier than others in their priority group.
The United States has paid for 200 million doses, enough to vaccinate 100 million people.
Moderna proposes to send 20 million this month and 80 million more in the first quarter of 2021, with the remaining 100 million in the second quarter.
(Except for the headline, this story has not been edited by NDTV staff and is posted from a syndicated channel.)
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