The FDA confirmed on Tuesday that the Moderna vaccine is safe and effective for use in adults, clearing the way for FDA approval for emergency use.
The findings bring the two-dose vaccine closer to final approval for the general population, which is expected to happen when an independent advisory board to the FDA takes up the review on Thursday. This is the panel that voted to approve the vaccine developed by Pfizer last week.
According to the FDA, the Moderna vaccine is 94 percent effective in providing immunity against the coronavirus on the second shot, and even more effective against severe cases of coronavirus, Politico reported.
Of the thirty people during testing trials who developed a severe case of coronavirus, all of them had received the placebo instead of the vaccine, and individuals who received the vaccine were only one third as likely to catch coronavirus at all.
Millions of doses are expected to be shipped out during remaining days of the year, which will allow up to 20 million Americans to be vaccinated before the months is out, with the distribution of both Moderna and Pfizer vaccines. Moderna expects to ship 6 million of their vaccine.
The vaccine has a number of minor side effects including pain, which occurs in over 90 percent of recipients, fatigue, headache, and muscle pain, which occurred for more than half of recipients, and joint pain and chills, which occurred in a large minority of vaccinated individuals. None of these side effects are considered detrimental for human health and most of the side effects were recorded only after the second dose of the vaccine was taken.
The FDA also noted one case of Bell's Palsy among the placebo group and three among the vaccinated group, but says there is no evidence linking the vaccine to such cases.
The vaccine requires two dosages to be considered effective, which is the same as the mRNA vaccine from Pfizer. An mRNA vaccine is a type of vaccine which does not infect you with a small dosage of virus antibodies to develop an immune system response. Instead, an mRNA vaccine inserts a synthetic sequence of the virus which prepares the immune system to protect against the real virus.
Moderna has also become the second of six companies that were part of the Trump administration's Operation Warp Speed, in which the government settled on three technologies to investigate to create a vaccine, and then enlisted six companies to do that research. Each technology was given to two companies to give each method the best chance of success.
Other vaccine developers have had their research stunted, with companies such as Sanofi and GlaxoSmithKline saying they will not have vaccines until the end of 2021. AstraZeneca, another vaccine developer, is expected to produce an effective vaccine early next year.
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