Covid-19 vaccine: Is the Pfizer vaccine FDA approved?

Health care workers and people in long-term care facilities are likely to receive the vaccine first
(University of Maryland Medical School)
Positive reports from several drug companies suggest that Americans may see a coronavirus vaccine spread as early as mid-December.
Pfizer and Moderna have both filed with the Food and Drug Administration (FDA) for emergency approval for their vaccine candidates, with Pfizer receiving the support of an FDA review panel Thursday night that, after a formal vote, will likely result in emergency approval. This means that the introduction of the two-dose vaccine program to the public could be imminent.
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Other companies like AstraZeneca are expected to apply for an emergency permit in the coming months.
Read more: Is the Pfizer Covid Vaccine Safe? This is what we know
The call for a vaccine comes at a time when the UK became the first western country to approve a coronavirus vaccine, putting pressure on the United States to make a similar statement. The vaccine distribution begins on Tuesday in the UK.
When and how will the vaccine be distributed to the US population? The Independent has summed up what Americans should likely expect in the coming months.
When will the vaccine be available to the public?
The question is difficult as the vaccine is likely to be distributed, with people at higher risk taking precedence over others in order to receive the vaccine.
Health officials have estimated that the vast majority of the public will have the option to get a coronavirus vaccine in spring or summer 2021 if approval and distribution continues as expected.
"When a vaccine is approved or approved in the US, enough doses may not be available for all adults," the Center for Disease Control and Prevention (CDC) explains on its website.
"The supply will increase over time, and it should be possible to vaccinate all adults later in 2021. However, a COVID-19 vaccine may not be available to young children until further studies are completed," he adds.
Some companies are just waiting for FDA approval before they can officially distribute the vaccine to states, which then individually decide how to distribute it to residents.
Operation Warp Speed, a federal government program under the Trump administration, would help manufacture and distribute these companies in order to get the vaccine to the vast majority of the public as soon as possible.
Federal officials have estimated that about 40 million doses of coronavirus vaccines will be available by the end of the year, which means 20 million people would get vaccinations since two doses are required. This estimate would require both Moderna and Pfizer to obtain emergency clearance from the FDA.
However, the initial number of vaccines available will likely be less than that number.
According to CNN, Pfizer is unlikely to have 6.4 million doses of vaccine ready until mid-December, meaning states will not be able to vaccinate all members of their first priority group during the first wave of distribution.
Read More: FDA Panel Votes Vaccine Against Pfizer Covid To Get Emergency Clearance
Who would get the coronavirus vaccine first?
A panel of independent experts advising the Centers for Disease Control and Prevention (CDC) voted last week to allow healthcare workers and those living in nursing homes and long-term care facilities to be the first to receive the coronavirus vaccine. The recommendation came after months of pondering what would be most beneficial to the public.
It was found that healthcare workers are at greatest risk of contracting the virus because they work on the front lines. Those who live in nursing homes that became hotspots when the pandemic began are also at higher risk of contracting the infection and dying from the novel virus.
Dr. Robert Redfield, the director of the CDC, can now decide whether to agree to the recommendation. In that case, the recommendation would be passed on to any state preparing to distribute the vaccine to residents.
This doesn't mean states need to follow CDC guidelines, but leading indicators have shown that most states are focusing on the communities at risk to get the vaccine first.
In New York, Governor Andrew Cuomo said the state expects 170,000 doses of the Pfizer vaccine by mid-December, and those doses would go first to health care workers and people sick in long-term health facilities.
Other states said they would likely follow similar guidelines for distribution.
Overall, the United States has approximately 21 million healthcare workers and support workers, and an additional 3 million residents who live in long-term care facilities.
The second wave of recipients of the vaccine will likely go to other key workers such as teachers, grocery store clerks, transport workers, etc., as well as those with comorbidities, putting them at a higher risk of developing serious complications from the virus.
Then the third phase would consist of young adults, children and workers who are "essential to the functioning of society", which would mean that around 85 to 95 percent of the population would be vaccinated.
The final phase would involve everyone else.
What does taking the vaccine entail?
The three biggest competitors for coronavirus vaccines - Pfizer, Moderna, and AstraZeneca - require two separate doses that are spaced apart. Pfizer vaccines are given every 21 days, Moderna every 28 days, and AstraZeneca every 30 days.
These vaccines are made with different compositions from each other and have different storage requirements. People who receive the vaccine will likely get both doses from the same company to get vaccinated.
The costs remain unclear.
Moderna and Pfizer agreed to sell 100 million cans to the federal government as part of Operation Warp Speed, which would be paid for using US taxpayers' money. These vaccines are distributed to the public free of charge.
However, the federal government has stated that recipients may have to pay administrative costs to get the vaccine.
“Vaccine providers can charge administration fees for delivering or administering the shot to someone. Vaccine providers can have this fee reimbursed by the patient's public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration's Provider Relief Fund, ”the CDC said on the website.
Health and government officials have indicated that they are working to make the vaccine free to the public, given the social benefit of anyone who receives the sting. But that will look like it is still up for discussion.

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