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Pfizer and BioNTech to seek regulatory clearance for their coronavirus vaccine

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It is only after the agency has given the green light that an initial limited group of high-risk people will be able to access the photos. Government officials plan to have enough vaccine to inoculate an estimated 20 million people with the two-dose regimen in the United States by December, between Pfizer and the BioNTechs vaccine and a second vaccine that may soon be considered for authorization. emergency, from the biotechnology company Moderna. The United States will receive about half of the 50 million doses Pfizer plans to produce by the end of the year.

There will likely be enough vaccines for 25 to 30 million people a month by early 2021, according to Moncef Slaoui, chief scientific adviser on Operation Warp Speed, the federal government’s initiative to accelerate vaccine development. He did not specify how many doses each company would contribute.

Snapshots of Pfizer’s data through press releases have so far exceeded expectations: the two-dose vaccine regimen was 95% effective in preventing disease in clinical trials and presented no major safety concerns, according to the company. It was 94% effective in people over 65, a critical concern group because older people are more likely to develop life-threatening illness after contracting the virus. The companies also submit two months of follow-up data on 38,000 of the 44,000 people in the trial. They will also present safety data on 100 children between the ages of 12 and 15, a group they recently started including in their trial.

Once Pfizer and BioNTech file their application, these results will be reviewed by regulators, including at a full-day advisory committee meeting where external scientists will meet to make recommendations to agency on whether to authorize the vaccine for wider use.

The companies have launched apps that are constantly updated with other regulators, including regulators in the European Union and the United Kingdom. Drugmakers have said they will be submitting claims in other countries within days. They are ready to distribute the first doses of vaccine within hours of a regulatory decision.

My message to the American people is to stay with us. Follow the simple steps the doctors talked about today because there is a light at the end of the tunnel. It’s not forever, Health and Human Services Secretary Alex Azar said in a briefing Thursday.

Pfizers’ announcement that it will apply for emergency clearance follows two weeks of blockbuster vaccine news, a period in which more than 1.5 million people in the United States have received diagnosed with covid-19, the disease caused by the coronavirus.

Our work to provide a safe and effective vaccine has never been more urgent, as we continue to see an alarming increase in the number of COVID-19 cases around the world, Pfizer Chief Executive Officer Albert Bourla said in a statement. communicated.

On Wednesday, Pfizer announced that its vaccine trial involving 44,000 people had met the necessary endpoints for safety and efficacy and that it could file for emergency clearance within days. The vaccine was 95% effective at preventing disease in the large clinical trial, and Pfizer and BioNTech had gathered sufficient safety data to support an application, with no major safety concerns identified.

On Monday, a vaccine candidate from the biotechnology company Moderna recorded an effectiveness of nearly 95% in a first analysis.

Half of the Pfizers trial participants received two doses of the study vaccine, and the other half received two injections of saline. Then, investigators waited to see which participants had fallen ill because they were exposed to the virus in their normal lives.

Of 170 cases of covid-19 to date, 162 in the placebo group were a strong signal that the vaccine was protecting people. Nine out of 10 cases of severe illness were in the placebo group, another strong sign that the vaccine protected against mild and severe cases. The most common adverse event rated as serious in the trial was fatigue, in 3.7% of participants after the second dose.

Emergency authorization for a vaccine is usually a lower standard than full approval. Still, the FDA guidelines have sought to set a high standard for a vaccine, even under emergency clearance. This guidance required that a vaccine be at least 50 percent effective, with a minimum of two months of safety data on half of the participants.

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