Pfizer/BioNTech COVID-19 Vaccine Nears Approval for Emergency Use in US
By VOA News
A COVID-19 vaccine developed by U.S. drug maker Pfizer and Germany’s BioNTech has moved closer to approval for emergency use in the United States after the Food and Drug Administration disclosed documents Tuesday confirming the vaccine was strongly protective against the infectious disease.
The FDA documents were released on the same day that Britain began inoculating citizens with the Pfizer-BioNTech vaccine, the first country to administer a fully examined vaccine for emergency use.
The documents offer the global community the first detailed view of the results of the vaccine’s trials.
An FDA advisory committee comprising independent experts will vote Thursday on whether to recommend use of the vaccine. The panel’s decision is not binding, but the FDA has usually accepted its recommendations.
A final decision by U.S. regulators is expected within days. If the vaccine is approved, the first recipients will be health care workers and nursing home residents, according to plans developed by each state.
FDA staff members said the two-dose vaccine was very effective in preventing COVID-19 cases at least seven days after the last dose.
But the FDA said there was not enough data to confirm the safety of the vaccine in people under 16, pregnant women and people with compromised immune systems.
COVID-19 is caused by the coronavirus.