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US FDA Approves Emergency Use of Pfizer’s COVID-19 Vaccine
Recommendation to use the ‘approved’ advisory committee in one day … United States, sixth country approved
“If you don’t approve urgently, submit your resignation.”
Foreign Press “Pressure on FDA Directs President Trump”
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The US Food and Drug Administration, FDA, has decided to approve the emergency use of the Pfizer-Bioentech COVID-19 vaccine. Connect with the reporters they cover. Reporter Kim Jeong-hoe Urgent use approval decided? Yes. The US Food and Drug Administration (FDA) approved the emergency use of the Pfizer-Bioentech COVID-19 vaccine at the 11th local time. A day has passed since the advisory committee made recommendations for use. This makes the United States the fifth country to approve the Pfizer vaccination after the United Kingdom, Bahrain, Saudi Arabia, Canada and Mexico. There were many foreign reports that there was pressure from the White House before approval. It seems this influence is great, but please share this information. Yes. Mark Meados, head of the United States Secretary of the White House, Eleventh Local Time, told the FDA Director of the Food and Drug Administration, Stephen Han, to resign if he did not quickly approve the emergency use of the Corona 19 vaccine developed by Pfizer-Bioentech. The approval date was until the 11th, the day of the call, and the FDA advisory committee issued an urgent-use approval recommendation the day before, so it appears that it warned not to delay any longer. Foreign media reported that the pressure was in accordance with President Trump’s instructions. In fact, President Trump compared the FDA to a slow turtle in a tweet and criticized Han, calling for a quick vaccination. In this regard, foreign media predicted that FDA approval would likely be announced a day earlier. As a result, it has been approved, but in fact, vaccination cannot start right away. This is because the CDC’s final announcement procedure remains based on the vote of the CDC Centers for Disease Control and Prevention Advisory Committee on the 13th. Unsurprisingly, the announcement on the 15th is forceful, but President Trump revealed in a Twitter speech some time ago that vaccination will begin within 24 hours, and it is noteworthy if vaccination will actually begin tomorrow. In this context, foreign media are pointing to the complicated guts of President Trump. Before the presidential elections, he expected the announcement of the vaccine development to be made based on his own achievements, but he was unsuccessful, and the dream of becoming the world’s first vaccination country was brought to the UK, and it is an analysis that would have judged it to be somewhat politically advantageous to speed up the time to approval and vaccination. On the other hand, there is news that the United States has decided to acquire more modders or vaccines. What is it about? Yes. As he said, the United States will buy an additional 200 million doses of the Corona 19 vaccine developed by Modena. Taking into account the vaccine, which is a two-dose vaccine, we are securing an additional quantity that can be adapted to 100 million people. US Secretary of Health and Human Services Alix Aza said that if additional modders are available by June next year, the number of vaccines under the Warp Speed plan will increase. The United States currently has a total of 600 million lots from Pfizer, 100 million lots from Modena, 300 million lots from AstraZeneca-Oxford University, 110 million lots from NovaVax, 100 million lots from Johnson & Johnson-Jansen and 100 million lots of Sanofi-Glaxo Miscline. It is in a safe state. However, it appears that the reason for getting additional vaccines from AstraZeneca and Sanofi will not go smoothly. For the AstraZeneca vaccine, the difference in preventive effect based on the amount of vaccination has not been identified, increasing the likelihood that FDA will delay approval. It has been announced that the Sanofi vaccine will not be launched until the end of next year due to the low immune response in the elderly as a result of the interim result of phase 2 clinical trials. Furthermore, the US Food and Drug Administration (FDA) convenes an advisory committee on the 17th, local time, to review the approval for the emergency use of modder or vaccines. If the advisory committee makes a recommendation for use, the FDA will soon decide whether to approve the emergency use and, after the CDC advisory committee decides whether to receive the vaccine, the CDC announces the decision to vaccinate, etc., the vaccination The modder’s main or shot will be done before Christmas. This is YTN Kim Jeong-hoe.
