Pfizer Plans to Submit Vaccine Candidate to FDA in Days

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On Wednesday, Pfizer announced plans to submit its vaccine candidate for emergency authorization in days.

On Wednesday, Pfizer announced plans to submit its vaccine candidate for emergency authorization in days, according to CNBC.

Furthermore, they announced that their coronavirus vaccine was actually 95 percent effective in preventing COVID-19 only one week after they announced the vaccine was more than 90 percent effective. The higher value was derived from a final data analysis. However, quite ironically, the announcement was also two days after Moderna announced that its vaccine had a 94.5 percent efficacy rate.

The vaccine is called BNT162b2 and starts to take effect against the virus 28 days after the first dose. Its effectiveness was consistent against all demographics and higher risk groups, such as the elderly, saw vaccine effectiveness greater than 94 percent.

“The final analysis underlines the results of the positive interim efficacy analysis announced on November 9,” BioNTech CEO Ugur Sahin said. “The data indicates that our vaccine ... is able to induce a high rate of protection against COVID-19 only 29 days after the first dose. In addition, the vaccine was observed to be well-tolerated in all age groups with mostly mild to moderate side effects, which may be due in part to the relatively low dose.”

The vaccine also appeared to prevent severe disease in volunteers. Nine of the 10 severe cases of Covid were in the placebo group in the phase three trial, the companies said. They also saw no “serious” safety concerns, with most adverse events resolving shortly after vaccination. The final data analysis revealed 170 confirmed cases out of 43,000 in the phase three trial. 162 cases of COVID were from the placebo group while eight cases were observed in the two-dose vaccine group.

It is unclear how long the vaccines will provide immunity. Individuals may need periodic booster shots, similar to tetanus.

“These vaccines are going to be approved and then rolled out with basically a few months’ worth of data. You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year” in the U.S., Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in a recent interview.

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