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Pfizer wants COVID vaccine OK as planned deployment

November 20, 2020-American pharmaceutical company Pfizer and its German partner BioNTech said Friday that they had submitted an application for an experimental coronavirus vaccine for approval.

But let’s not still be in line.

If the FDA grants Pfizer an emergency license, the coronavirus vaccine will be rolled out in stages. Some Americans may not get it until mid-2021.

The FDA Advisory Board will meet on December 8-10 to discuss both the Pfizer vaccine and the vaccine manufactured by Modena and will apply for an emergency license. Both are two-shot vaccines.

If the Commission approves Pfizer’s vaccine, distribution may begin within 24 hours. The Pfizer vaccine is already manufactured under a $ 1.95 billion contract with the government. In addition, some states already have plans on how to distribute the vaccine.

Who will be vaccinated first?

The CDC Vaccination Implementation Advisory Board will decide on the distribution. USA Today The National Academy of Science and Technology has reportedly advised the CDC on priorities. Their priorities are as follows:

  • Phase I, Part I: Frontline healthcare, ambulance drivers, cleaners, and first responders. This is about 5% of the US population.
  • Phase I, Part II: People aged 65 and over who are in a serious condition such as cancer or heart disease and are at very high risk of serious infection or death, and in group living facilities such as nursing homes, homeless shelters, and prisons. That’s about 10% of the population.
  • Phase II: COVID-19 for everyone over 65, teachers, childcare workers, people in moderate risk health, people under 65 and working there in camps, and public transport Important workers who cannot avoid exposure to transit employees or food supply workers. It is 30% to 35% of the population.
  • Phase III: Young adults and people working in higher education, hotels, banks, sports facilities and factories. It is 40% to 45% of the population. It’s unclear if children will be included in this group, USA Today Said.
  • Phase IV: People who did not fit into any other stage-5% to 15% of the population.

The schedule has not been announced, but Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and US COVID authority, should recently make the coronavirus vaccine generally available sometime between April and July. I said that.

Speed ​​is very important. While the government is making decisions, the coronavirus continues to sick Americans and choke the national economy.

The United States recorded the 250,000th coronavirus-related death this week, recording 11.5 million cases, more than any other country since the pandemic began. On Thursday, the United States recorded 170,161 new confirmed cases and 2,000 deaths.

Clock status

The state is also responsible for the distribution of vaccines under President Donald Trump’s policy of having the state set its own policy to combat the COVID pandemic. Some of them have already explained the plan.

In Ohio, Governor Mike DeWine has announced 10 state-wide sites to receive vaccines after the FDA grants an emergency permit, he said in a news release.

“Ohio will first vaccinate the highest-risk people, including those working in long-term care facilities, nursing homes and other multidisciplinary care facilities, high-risk health care workers, and first responders.” The release states.

The Mayo Clinic, Minnesota, says it is ready to begin vaccination in late December. Twin Cities Pioneer press..

“We are very confident that at least a small target population, which has not yet been determined, will be vaccinated with at least one vaccine by the end of the year,” said Dr. Melanie Swift, MD, this week.

Pfizer vaccines are first approved for use in the United States. Clinical trials have shown that two-shot vaccines are 95% effective in preventing infections, the company said in a news release.

In a release, Pfizer Chairman and CEO Dr. Albert Bourla said, “Our efforts to provide safe and effective vaccines are no more urgent than ever. did. .

The company also submits “rolling submissions” for approval from government agencies around the world.

Others on the way

Other vaccines may be on the market soon. Moderna said the vaccine is about 95% effective. AstraZeneca and Johnson & Johnson are in the late stages of clinical trials of the vaccine.

An emergency license (EUA) is not the same as a full approval. The EUA allows the drug to be available in the event of a health crisis before all tests are completed.

Vaccine development usually takes years, but the seriousness of the coronavirus pandemic has pushed the process forward.

The EUA can be withdrawn, as it happened earlier this year when researchers discovered that the antimalarial drug hydroxychloroquine did not help people with the coronavirus.

Due to the high interest in vaccines, the FDA announced this week that it will open the EUA process to the public.

“Today’s transparency behavior is one of the many steps we are taking to ensure public confidence in the EUA review process for pharmaceuticals and biological products, especially potential COVID-19 vaccines. “I’m sorry,” FDA Commissioner Stephen Hahn, MD, said in a statement.

WebMD Health News

Source

Pfizer. “Pfizer and BioNTech file an emergency license request for the COVID-19 vaccine with the US FDA today.”

US Department of Health and Human Services: “The US government has asked Pfizer to make millions of COVID-19 vaccines.”

USA Today: “The panel of experts recommends who should be in the first line of COVID-19 vaccine. Where is your family?” “Fauci says that the average American will be in April as soon as possible. He says he can be vaccinated against COVID-19. “I will be vaccinated.” “

Ohio Governor Mike DeWine: “Covid-19 Update: 21-day Curfew”

Twin Cities Pioneer Press: “The Mayo Clinic is preparing to launch a limited COVID-19 vaccination in December.”

FDA.gov, June 15, 2020, letter from Maj. Gen. Dennis Hinton, Chief Scientist.

FDA: “COVID-19 Update: COVID-19 EUA’s ongoing commitment to transparency.”


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Pfizer wants COVID vaccine OK as planned deployment

Source link Pfizer wants COVID vaccine OK as planned deployment

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