November 20, 2020 – U.S. pharmaceutical company Pfizer and its German partner BioNTech said on Friday that they would seek government approval today for an investigational coronavirus vaccine.
But don’t start lining up for a shot yet.
If the FDA grants emergency use clearance to Pfizer, a coronavirus vaccine would be rolled out in stages. Some Americans might not get it until mid-2021.
An FDA advisory committee is set to meet Dec. 8-10 and could discuss both the Pfizer vaccine and one produced by Moderna, which has also announced plans to seek emergency use authorization. Both are two-dose vaccines.
If the committee approves Pfizer’s vaccine, distribution could begin within 24 hours. The Pfizer vaccine has already been manufactured under a $ 1.95 billion contract with the government. And some states have already made plans on how to distribute the vaccine.
Who gets the vaccine first?
The CDC Advisory Committee on Immunization Practices will decide on the distribution. USA today reported that the National Academies of Science, Engineering and Medicine have advised the CDC on priorities. These priorities are:
- Phase I, part I: Primary health care, ambulance drivers, cleaners and first responders. This represents about 5% of the American population.
- Phase I, part II: People with serious illnesses such as cancer and heart disease that put them at a significantly higher risk of serious infection or death, as well as people over 65 living in groups in nursing homes, homeless shelters and prisons. This represents about 10% of the population.
- Phase II: All other people over 65, teachers, educators, people whose state of health puts them at moderate risk, people under 65 in detention centers and those who work there, and critical workers who cannot avoid exposure to COVID-19, such as public transit workers or food supply workers. This represents 30 to 35% of the population.
- Phase III: Young adults and people working in higher education, hotels, banks, exercise facilities and factories. This represents 40 to 45% of the population. It is not known if children would be included in this group, USA today said.
- Phase IV: People who do not fit into any other phase – 5% to 15% of the population.
A schedule has not been released, but Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the National COVID Authority, recently said that a coronavirus vaccine should be available widely. public from April to July.
Speed is everything. While the government makes decisions, the coronavirus will continue to hurt Americans and stifle the national economy.
The United States recorded its 250,000th coronavirus-related death this week and has scored 11.5 million cases since the start of the pandemic – more than any other country. On Thursday, the United States recorded 170,161 new confirmed cases and 2,000 deaths.
States on the clock
As part of President Donald Trump’s policy of letting states set their own policies to deal with the COVID pandemic, states would also be responsible for the distribution of vaccines. Some of them have already outlined plans.
In Ohio, Governor Mike DeWine announced 10 sites across the state that will receive the vaccine once the FDA grants an emergency use clearance, he said in a press release.
“Ohio will first vaccinate those most at risk, including those working in long-term care facilities, nursing homes and other collective care facilities, healthcare workers at high risk and first responders, “the statement said.
In Minnesota, the Mayo Clinic says it is ready to begin vaccinations in late December, according to the Twin towns Pioneer Press.
“We are very confident that we will have at least one vaccine by the end of the year for at least a small target population, which has yet to be decided,” said Melanie Swift, MD, this week.
Pfizer’s vaccine would be the first to be approved in the United States. Clinical trials show that the two-dose vaccine was 95% effective in preventing infections, the company said in a press release.
“Our work to provide a safe and effective vaccine has never been more urgent as we continue to see an alarming increase in the number of COVID-19 cases around the world,” said Albert Bourla, PhD, chief executive officer from Pfizer, in the press release. .
The company also submits “continuous submissions” for approval to government agencies around the world.
Others also on the way
Other vaccines may soon hit the market. Moderna said his vaccine shows around 95% effectiveness. AstraZeneca and Johnson & Johnson are in the final stages of their clinical vaccine trials.
An Emergency Use Authorization, or EUA, is not the same as a full approval. An EUA allows a drug to be made available during a health crisis before all testing is complete.
Normally it takes years to develop a vaccine, but the severity of the coronavirus pandemic has prompted the government to speed up the process.
EUAs can be removed, as happened earlier this year when researchers found that the antimalarial drug hydroxychloroquine was not helping people with the coronavirus.
Due to the great interest in the vaccine, the FDA said this week that it will make the EUA process open to the public.
“Today’s transparency action is just one of many steps we are taking to ensure public confidence in our EUA review process for medicines and biologics, in particular any potential COVID-19 vaccine, ”FDA Commissioner Stephen Hahn, MD, said in a statement. .
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