Pfizer vaccine is 95% effective, plans to submit to FDA in ‘days’

Pfizer and BioNotech said on Wednesday that a final data analysis found that their coronavirus virus vaccine was 95% effective in preventing Kovid-19, and, in addition, appeared to avoid serious illness.

Drugmakers stated that the vaccine, called BNT162B2, was highly effective against the virus 28 days after the first dose, and its effectiveness was tailored to all ages, races, and breeds. Additionally, the elderly, who are seen as having a higher risk of serious illness from Kovid-19, saw more than 94% of vaccinations, they added.

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

The vaccine also appeared to prevent serious illness in volunteers. The companies said that Kovid-19 had 10 serious cases, of which nine cases belonged to the placebo group in three cases. There were no “serious” safety concerns, he said, resolving most adverse events immediately after vaccination.

Shares of the company jumped 3% in premarket trading.

The final analysis evaluated 170 confirmed Kovid-19 infections among more than 43,000 participants in the late-stage trial. The companies stated that 162 cases of Kovid-19 were seen in the eight cases versus the placebo group, in the group that received the two-dose vaccine. The estimated vaccine efficacy was 95%, he said.

More than a week after the companies announced that their vaccine was more than 90% effective, and two days later Modern said three early-stage test data showed that its vaccine was 94.5%. Both vaccines use messenger RNA, or mRNA, technology. This is a new approach to vaccines that uses genetic material to provoke an immune response.

A safe and effective vaccine is seen by investors and policy makers as a solution to get the global economy back on track after the havoc wreaked havoc on almost every country and business in the world. According to data compiled by Johns Hopkins University, with more than 55.6 million cases worldwide and at least 1.33 million deaths on Wednesday, the virus is spreading rapidly.

Pfizer and BioNTech’s preliminary results on November 9 were based on the first interim efficacy analysis conducted by an external and independent data monitoring committee from a phase three clinical trial. The independent group of experts oversees US clinical trials to ensure the safety of participants.

Medical experts note that it is unclear how long the vaccines will provide immunity and whether or how often people may need periodic booster shots.

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

Pfizer said it plans to submit an application for emergency use authority to the Food and Drug Administration “within days”. Pfizer CEO Albert Borla said at Tuesday’s New York Times dealbook conference that the company had accumulated enough safety data to submit the vaccine for review.

The companies reiterated that they expect to produce up to 50 million this year and 1.3 billion doses in 2021. They also said they are “confident” over their ability to deliver the vaccine, which requires a storage temperature of minus 94 degrees Fahrenheit. . In comparison, Modern’s vaccine can be stored for up to six months at a negative 4 ° F.

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