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FDA Accelerates Pfizer Final Approval Schedule-BioNTech COVID-19 Vaccine

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The US Food and Drug Administration (FDA) has announced that Pfizer-BioNTech (NYSE:) PFE) (Nasdaq: BNTX) It is a COVID-19 vaccine and is scheduled to be inoculated by early September.

Sources on Tuesday in The New York Times, regulators Informal deadline for Workers’ Day To make a decision regarding a biologics license application (BLA) for a double dose shot.

Initially, the FDA targeted early January 2022 He called for action on the application, but commissioner Dr. Janet Woodcock recently said that reviews could come much sooner, as they are one of the authorities’ top priorities.

The FDA refused to comment on the specific schedule of approval expected on Wednesday, Promoted that review In the steadily increasing number of new cases across the United States due to the Delta variant.

“Recognizing the urgency associated with the current state of the pandemic, we took a full-scale approach,” an FDA spokesman told Politico, adding that authorities have put additional personnel and resources into the effort. ..

Public health officials believe that full approval may increase confidence in injections for individuals who dislike vaccines.

Any of the three vaccines Allow emergency use In the United States, it is fully licensed by the FDA by Pfizer-BioNTech, Moderna, Johnson & Johnson. Moderna filed for full approval of the 2-shot vaccine in June, and Johnson & Johnson will begin the process shortly.

Recent survey from Kaiser Family Foundation We found that 31% of unvaccinated adults said they were more likely to be vaccinated if one of the shots currently allowed for emergency use was fully approved by the FDA.

Pollsters point out that many respondents were unaware of the difference between the two types of approvals, or whether the vaccine was already approved, and the findings could replace a wide range of skeptics’ concerns. Suggested that there is sex.

As of Wednesday, 165 million Americans (49.8% of the population) have been fully vaccinated and 192 million (58% of the country) have been vaccinated at least once. .. Centers for Disease Control and Prevention..

More contagious delta mutants are widespread, hospitalizations surge, Maskman date At the COVID-19 hotspot.

Individuals who hesitate to vaccinate still represent tens of millions of Americans, many of whom have been hit hard. Southern and Midwestern states The latest wave of incidents is straining hospitals and public health resources.

Final approval can also help form vaccine obligations and form prompt requirements from employers, schools and other institutions.

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NS More and more companiesSeveral state and local governments, including Microsoft Corporation, Tyson Foods, and Facebook, such as California and New York City, Obligation to take a shot..

President Joe Biden has enacted a similar mission Federal workers last week.

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sauce: Equity news



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