October 3, 2022

Medical Trend

Medical News and Medical Resources

FDA Approved Pfizer COVID-19 Vaccine

FDA Approved Pfizer COVID-19 Vaccine

FDA Approved Pfizer COVID-19 Vaccine. FDA approved! Vaccination will start on Monday as soon as possible! People are waiting for spring! U.S. purchases 200 million vaccines, enough for 100 million people.

FDA Approved Pfizer COVID-19 Vaccine

The Federal Food and Drug Administration (FDA) approved the emergency use of the first COVID-19 vaccine in the United States on the evening of the 11th. Health Secretary Alex Azar expects that the Pfizer vaccine can be injected by Chinese people as soon as 14 days.

However, two government officials revealed that earlier in the day, White House Chief of Staff Mark Meadows gave an ultimatum to FDA Commissioner Stephen Hahn. If the FDA did not approve the COVID-19 vaccine on the 11th, Hahn would have to seek him out. Responsibilities, resulting in the FDA’s announcement of approval one day in advance.

The emergency use of Pfizer’s COVID-19 vaccine authorized by the United States will become a turning point in the fight against the epidemic and make the United States the sixth country in the world to authorize the use of the vaccine. Other countries include the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico. The European Union is expected to approve it within a few weeks.


After the COVID-19 vaccine developed by Pfizer is approved, the next step of low-temperature transportation will not tolerate any negligence. The vaccine must be stored below minus 80 degrees Celsius.

The United States added more than 3,300 COVID-19 pneumonia deaths on the 10th. After two consecutive days, the FDA authorized the emergency use of Pfizer vaccine on the 11th. The first wave of 2.9 million doses of COVID-19 vaccine will be delivered within 24 hours, and millions of high-risk people It is expected to start vaccination within a few days.

Achar told ABC News earlier on the 11th that people other than clinical experimenters can start vaccinating the COVID-19 vaccine as early as the 14th or 15th. We will cooperate with Pfizer to deliver the vaccine. People were vaccinated on Monday or Tuesday.

Government officials predict that 20 million Americans will be vaccinated against the COVID-19 in December. On the 11th, Achar expects 100 million Americans to be vaccinated by the end of February next year, but the vast majority of Chinese people may have to wait several months or until the spring. Vaccination.

The FDA originally planned to approve the emergency use of Pfizer vaccine on the morning of the 12th, but an anonymous source revealed that Medos called on the 11th to put pressure on Hahn to warn Hahn that if the FDA did not approve the authorization on the same day, Hahn would submit his resignation. Approved in the evening.


Hahn issued a rare statement on the morning of the 11th announcing that the FDA is accelerating the emergency use of the COVID-19 vaccine. Hahn also told the FDA Center for Biologics Evaluation and Research (CBER) to complete the approval before the end of the day.

A few minutes later, President Trump directly criticized Hahn in a tweet, asking Hahn not to play games and save people as soon as possible, and criticized the FDA for being a big and old slow turtle with a lot of money and red tape.

The New York Times reported that it is not clear whether shortening the half-day authorization schedule can speed up the delivery of vaccines to all parts of the country, or only meet the requirements of Medusa; multiple officials said that the schedule for vaccine delivery has already been arranged.

 

New Times reported that upper pressure will not change the results of the procedure. Several officials pointed out that after the FDA’s external vaccine advisory group recommended the emergency use of the FDA vaccine on the 10th, the agency had already decided to approve it; however, the move by Medus highlighted the White House’s no intention to let the regulators. Maintain its original plan and work independently.

White House officials are reluctant to comment on private conversations, but said the chief of staff often requests updates on vaccine progress; Hahn later issued a statement saying: This does not truly reflect the content of the call with the chief of staff, (Medus) encouraged the FDA to continue to work quickly.

COVID-19 pneumonia vaccine research and development company Moderna (Moderna) announced on the 11th that the US government plans to purchase an additional 100 million doses of vaccine from the company.

Together with the 100 million doses of vaccine originally purchased by the Trump administration for 1.5 billion yuan in August this year, the total number of Moderna vaccines has reached 200 million doses; however, because the vaccine must be vaccinated in two doses, the Moderna vaccine will be sufficient to supply the country in the future Used by 100 million people.

 

Operation Warp Speed, a vaccine development program led by the Trump administration, has paid 4.1 billion yuan to Moderna, including 955 million yuan to assist in vaccine trials.

At the same time, the federal government also purchased 100 million doses of vaccines jointly developed by the domestic pharmaceutical company Pfizer and the German biotech company BioNTech.

More than 20 top scientists and physicians in the independent vaccine review team finally approved the use of Pfizer’s vaccine on the 10th, except for their endorsement and stating that the vaccine is safe and effective for adults and adolescents over 16 years old.

Federal Minister of Health Alex Azar stated on the ABC news program Good Morning America on the 11th: We may be able to see the first batch of people on the 14th or 15th. vaccination.

 

The independent team review of the Moderna vaccine is scheduled to be conducted on the 17th. If the emergency use authorization is also approved by the FDA, it seems that the FDA is likely to approve the vaccines produced by the two pharmaceutical companies.

Once Moderna is authorized, it will provide 20 million doses of vaccine before the end of this month, and another 100 million doses will be distributed in January, February and March next year. As for the vaccines purchased on the 11th, Released in the second quarter of next year.

Achar said: As of June next year, we will ensure that there are another 100 million doses of Moderna vaccine, and further expand the rapid task of the national vaccine supply chain; this new purchase will ensure that even the second dose next year People all over the country will have enough vaccines in this season.

The National Institutes of Health (NIH) also participated in the development of the Moderna vaccine, and the final trial stage confirmed that the vaccine was 94.5% effective in preventing COVID-19 pneumonia

 


Disclaimer of medicaltrend.org