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

Positive reports from several pharmaceutical companies have indicated Americans might see distribution of a coronavirus vaccine beginning as early as mid-December.

Pfizer and Moderna have both applied for emergency authorisation from the Food and Drug Administration (FDA) for their vaccine candidates, with Pfizer’s gaining the support of an FDA review panel on Thursday evening, which will likely lead to emergency authorization following a formal vote. That means the rollout of the two-dose vaccine program to the public could be imminent.

Other companies, like AstraZeneca, are also expected to apply for emergency authorisation in the coming months.

Read more: Is the Pfizer Covid vaccine safe? Here’s what we know

The push for a vaccine comes at a time where the United Kingdom has become the first Western country to approve a coronavirus vaccine, putting pressure on the United States to make a similar declaration. Vaccine distribution will start in the UK on Tuesday. 

So when and how will the vaccine be distributed to the US population? The Independent has rounded up what Americans should likely expect in the coming months. 

The question is a tricky one given how the vaccine will likely be distributed, with higher-risk individuals prioritised over others to receive the vaccine.

Health officials have estimated the vast majority of the public will have the opportunity to receive a coronavirus vaccine in spring or summer months of 2021, if approval and distribution continue as expected.

“When a vaccine is authorized or approved in the United States, there may not be enough doses available for all adults,” the Centres for Disease Control and Prevention (CDC) explains on its website. 

“Supplies will increase over time, and all adults should be able to get vaccinated later in 2021. However, a COVID-19 vaccine may not be available for young children until more studies are completed,” it adds. 

Several companies are just waiting on the approval from the FDA before they can start officially distributing the vaccine to states, which will then individually decide how to give it out to residents.

Operation Warp Speed, a federal government program under the Trump administration, would be assisting these companies in manufacturing and distribution to help get the vaccine to the vast majority of the public as swiftly as possible.

Federal officials have estimated about 40 million doses of coronavirus vaccines will be available by the end of the year, meaning 20 million people would receive vaccinations because it requires two doses. This estimate would require both Moderna and Pfizer to receive emergency authorisation from the FDA. 

But the initial number of vaccines available will likely fall short of that number. 

Pfizer is only expected to have 6.4 million doses of vaccine ready by mid-December, CNN reports, meaning states will be unable to vaccinate everyone in their first priority group during the first wave of distributions. 

Read more: FDA panel votes for Pfizer Covid vaccine to receive emergency authorisation

A panel of independent experts advising the Centres for Disease Control and Prevention (CDC) voted on last week for healthcare workers and people living in nursing homes and long-term care facilities to be the first to receive the coronavirus vaccine. The recommendation came after months of deliberation on what would be most beneficial to the public.

It was determined that healthcare workers were most at risk to contract the virus, as they are working on the frontlines. Those living in nursing homes, which became hotspots at the start of the pandemic, are also at higher risk to contract and die from the novel virus.

Dr Robert Redfield, the director of the CDC, can now decide if he agrees with the recommendation. If so, the recommendation would be released to each state as they prepare to distribute the vaccine to residents.

This does not mean that states have to follow the CDC guidelines, but early indicators have shown most states are focused on those at-risk communities to receive the vaccine first.

In New York, Governor Andrew Cuomo said the state anticipated 170,000 doses of the Pfizer vaccine by mid-December, and those doses would go first to healthcare workers and people who are sick in long-term health facilities.

Other states indicated they would likely follow similar guidance for distribution.

In total, there are about 21 million healthcare workers and support staff in the US, and an additional 3 million residents living in long-term care facilities.

The second wave of recipients for the vaccine will likely go to other essential workers like teachers, grocery store clerks, transportation workers, etc, as well as those with comorbidities making them more at-risk to develop serious complications from the virus. 

Then phase three would be made up of young adults, children, and workers “essential to the functioning of society”, which would mean about 85 to 95 per cent of the population would be vaccinated. 

The final phase would involve everyone else.

The top three coronavirus vaccine contenders – Pfizer, Moderna, and AstraZeneca – require two separate doses spaced out from each other. The Pfizer vaccines are given 21 days apart, Moderna’s are given 28 days apart, and AstraZeneca’a are given about 30 days apart.

These vaccines are made with a different composition from each other and involve different storage requirements. So people who get the vaccine will likely get both doses from the same company in order to be vaccinated. 

As for cost, that remains unclear.

Moderna and Pfizer agreed to sell 100 million doses to the federal government under Operation Warp Speed, which would be paid for using US taxpayer dollars. These vaccines will be distributed to the public for free.

But the federal government has said that recipients might have to pay the administration costs to receive the vaccine.

“Vaccine providers will be able to charge administration fees for giving or administering the shot to someone. Vaccine providers can get 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 says on its website.

Health and government officials have indicated they are working to make the vaccine free for the public, given the societal benefit of everyone receiving the jab. But that will look like is still up for discussion.