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WASHINGTON: The United States has authorised Moderna’s COVID-19 vaccine for emergency use as the government struggles to quell the pandemic that is killing over 2,500 people a day in the country.
US Food and Drug Administration (FDA) chief 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!” tweeted President Donald Trump. The US is the first nation to authorize the two-dose regimen from Moderna, now the second vaccine to be deployed after the first one by developed by Pfizer and BioNTech.
The Pfizer-BioNTech vaccine was approved by Britain on December 2, followed by several other countries including the US last week. Millions of doses will now start shipping out as early as this weekend from cold-storage sites outside Memphis and Louisville and delivered to sites around the country.
Moderna has several other drugs under development but has never before seen any authorised. The decade-old biotech company received $2.5 billion in federal funding for its efforts and co-developed the vaccine with scientists at the National Institutes of Health.
Both the Pfizer and Moderna vaccines are based on cutting-edge mRNA (messenger ribonucleic acid) technology and have been shown to be highly effective, protecting about 95 percent of people against COVID-19. They have also been found to have no serious safety issues in clinical trials involving tens of thousands of people each.
The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever.
There have now 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. Both vaccines come with warnings for people who have histories of allergic reactions to their ingredients.
FDA scientist Peter Marks told reporters that the total number of cases of allergic reactions to the Pfizer vaccine across the United States was now “roughly five.” He said investigations were underway, but said the culprit might be an ingredient called polyethylene glycol, which is in both vaccines.
The FDA will also be on the lookout to see whether both vaccines may in extremely rare cases be linked to Bell’s palsy, a relatively mild and temporary facial paralysis condition. There were a handful of such cases in the clinical trials.
Both of the vaccines work by giving human cells the instructions to make a surface protein of the coronavirus, which simulates an infection and trains the immune system for when it encounters the real virus.
They each differ in the formulation of the fatty particles used to deliver the mRNA, which allows Moderna’s vaccine to be kept in long term storage at -20 degrees Celsius (-4 degrees Fahrenheit), unlike Pfizer’s, which must be stored at -90 degrees Celsius.
Moderna carried out a clinical trial of more than 30,000 people, roughly half of whom were given the product and the other half a placebo, with neither recipients nor their health care providers knowing who was in each group.
It has proposed to “unblind” the whole study and offer placebo recipients the vaccine, a plan criticized by some experts who say scientists will be deprived of valuable data, and some people will end up getting the vaccine ahead of others in their priority group.
Moderna proposes to ship 20 million this month and 80 million more in the first quarter of 2021, with the remaining 100 million in the second quarter.