- The US Food and Drug Administration granted an emergency use authorization for the Pfizer vaccine, developed with German partner BioNTech.
- The vaccine was shown to be 95% effective in preventing the disease in a late-stage trial.
- Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses.
The US Food and Drug Administration has authorized the first Covid-19 vaccine for emergency use in the United States, reports CNN.
Millions of doses of the Pfizer and BioNTech coronavirus vaccine, which has been found to be 95% effective, will be soon shipped around the country so vaccinations can begin within days.
FDA authorization
The first Emergency Use Authorization (EUA) was issued to the COVID-19 vaccine of American drugmaker Pfizer in partnership with German company BioNTech, allowing the vaccine to be distributed in the United States.
The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19, said the FDA in a statement.
Potential benefits on the list
The data also show that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, said the FDA.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen Hahn.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” he said in a statement.
Vaccine mechanism
The Pfizer-BioNTech vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein.
When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
The vaccine is administered as a series of two doses, three weeks apart.
Vaccine distribution to begin soon
As vaccine doses get distributed across the country, state and local officials will oversee the distribution of the vaccine in their states as well as the logistics — and health care workers and residents of long-term care facilities are prioritized to receive the vaccine first.
At this point, the number of doses each state is getting in its first shipment is fluid and, in many cases, the amount is less than what states were initially told to expect, leading states to change distribution plans.
In most cases, the first shipments of the vaccine will be transported from Pfizer’s facility in Kalamazoo, Michigan, to hospital systems and pharmacies.
The distribution from vaccine production company to individual hospitals and pharmacies in each state as directed by the federal government, is different for almost every state.
State health department officials are coordinating with federal officials in Operation Warp Speed. However, there is no clear roadmap that explains how this process is working simultaneously in all 50 states.
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Source: CNN
