FDA Has Authorized Emergency Use Of The Pfizer/BioNTech Covid-19 Vaccine In America

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The Food and Drug Administration has approved the Pfizer/BioNTech Vaccine for emergency use after it received recommendations about its safety on Thursday by a panel of 23 experts. 

"We have clear evidence that the vaccine is highly effective at least three months after getting the first dose, and given the other data they presented, I think it's likely to be effective for much longer," Dr. Paul Offit told NPR in advance of the FDA announcement.

The US now joins the UK, Canada, Bahrain, and Saudi Arabia. Vaccinations in the UK began on December 8.

Pfizer and BioNTech submitted an Emergency Use Authorization (EUA) request to FDA on November 20 as their Phase 3 trial data was concluded. The FDA has notified the US Centers for Disease Control as well as Operation Warp Speed, the federal government's vaccine distribution program so that the vaccine can begin to be distributed across the North American country.

Distribution of the vaccine is expected to start within the next 24 hours, beginning from people who are most at risk from the disease, that has killed so far about 300,000 Americans and 1,6 million people worldwide.

The data shows that the vaccine has an efficacy of 95 percent with the immunization being in place about two weeks after the first of two doses. The current data shows that the protection does not wane for at least two months after the second dose and future data will give an even better understanding of long-term protection.

The vaccine is well tolerated with the main side-effect is localized pain at the injection site for 80 percent of the participants, with the other fifth not experiencing any pain at all. One percent experienced severe pain.  

The Pfizer/BioNTech vaccine is the first-ever approved mRNA vaccine. Vaccines are designed to train the immune system to deal with a specific pathogen in this case, the coronavirus SARS-CoV-2. There are different approaches to do this training and create immunity. mRNA vaccines do that by tricking our cells into producing a bit of the virus.

The bit is a spike protein located on the external membrane of the virus. It is not harmful to us but allows our immune system to familiarize with it and recognize it as a foreign object. The goal is that when they actually encounter this protein attached to SARS-CoV-2, they can easily recognize the virus as a pathogen and attack it immediately.

The two companies announced that they will be able to produce 50 million doses by the end of the year and 1.3 billion in 2021. There are 6.4 million doses earmarked for the US for this month expected to cover one percent of the population.

For more information about Covid-19, check out the IFLScience Covid-19 hub where you can follow the current state of the pandemic, the progress of vaccine development, and further insights into the disease.

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