Will they approve the use of the COVID-19 vaccine in the United States?
After several hours of an intense meeting that took place this Thursday, followed online, the Advisory Committee on Vaccines and Related Biological Products of the Food and Drug Administration (FDA) recommended to the FDA the authorization of the emergency use the COVID vaccine -19 from Pfizer BioNTech.
According to CNBC, 17 members of the Expert Committee voted in favor after analyzing various topics against four against and one abstained.
Now the final decision will be in the FDA’s hands, which must issue its final response in the coming days. Although their determination is independent, the Committee of experts’ support gives ample hope that the response will be positive since they have issued their comments before approving all types of vaccines previously, as has been the case of the immunizations against influenza.
FDA Finds Pfizer Vaccine Effective and Safe | Telemundo NewsOfficial video of Noticias Telemundo. Based on the pharmaceutical company’s data and the initial analysis concluded, the agency noted that the vaccine generates strong protection from the first dose and is effective. Next, the FDA will meet to discuss the results of phase three of the study.
According to the latest calculations by the United States health authorities, so far in the country, some 15 million people have been infected with the virus, and some 288,000 have lost their lives.
Among the points to highlight in their analysis of the vaccine, the board mentioned that people with a clinical history of allergies to the vaccine components should not get it.
How COVID-19 vaccines will be distributed in each state of the country | Telemundo NewsOfficial video of Noticias Telemundo. The vaccines will be distributed according to the population of each state. New York will receive 200,000 doses in the first stage, while California, Texas and Florida will exceed this figure. States will place new orders at the end of each week.
“For the past two weeks, we have been working with Pfizer to generate fact sheets and prescribing information,” said Dr. Marion Gruber, director of the Office of Vaccine Research and Review at the Center for Biologics Research and Evaluation of the FDA.
FDA begins evaluation for the use of Pfizer vaccine | Telemundo NewsOfficial video of Noticias Telemundo. The Advisory Committee of the US Food and Drug Administration started the meeting on Thursday to analyze whether the COVID-19 vaccine developed by Pfizer and BioNTech is effective and safe for emergency use in the country.
Despite the expert panel’s determination, CNN explained that this does not mean that the use of the vaccine is already officially authorized in the states of the American Union immediately since the body in charge of making the final decision is the FDA.
Pfizer: Full vaccine results indicate its Covid-19 vaccine is 95% effective. Pfizer and BioNTech said Wednesday that a final data analysis found their coronavirus vaccine was 95% effective in preventing Covid-19 and also appeared to fend off severe disease. CNBC’s Meg Tirrell reports. Subscribe to CNBC PRO for access to investor and analyst insights: https://cnb.cx/2Vtntx6 Pfizer and BioNTech said Wednesday that a final data analysis…2020-11-18T12: 04: 14Z
“The FDA will decide whether or not to issue an emergency use authorization for the vaccine. The FDA’s EUA allows shipping to begin. Still, injections cannot yet be administered until the US Centers for Disease Control and Prevention advisory committee recommends the vaccine, “said the news mentioned above the channel.
CNN further noted that the CDC’s Advisory Committee on Immunization Practices would hold emergency meetings on Friday and Sunday to determine whether they will also recommend that the vaccine be applied in the country, which will be the last step for vaccines. Start getting into patients in the United States.
JUST IN: FDA advisers vote to recommend that the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine in the US https://t.co/0yobC3HM2d
— CNN (@CNN) December 10, 2020
The big question now will be whether the FDA will authorize the Pfizer and BioNTech vaccine for groups that were not initially considered, such as pregnant women and children under 16 years of age.