The first batch of a clinically approved vaccine is being distributed in the U.K. beginning Dec. 7. The vaccine was developed in cooperation by pharmaceutical and biotechnology companies Pfizer and BioNTech.
Fifty different hospitals across the U.K. have been chosen to distribute the vaccine beginning with individuals over 80 years old, health care workers and those who live in nursing homes. The Pfizer and BioNTech vaccine is a two-dose vaccination reported to be 95 percent effective after the first 28 days of the initial dose. Through multiple trials, Pfizer and BioNTech released that this efficacy was consistent among all age groups, races, genders and ethnicities.
By the end of 2020, the companies plan on producing up to 50 million doses of the vaccine, and by the end of 2021, 1.3 billion doses. But how will these doses be distributed?
On Nov. 18, Pfizer and BioNTech released a statement which stated that the companies would be submitting their data findings and vaccine to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA). In the same press release, the companies also revealed that they had already reached the “safety data milestone” for the EUA.
“I would get the vaccine, but after a couple of rounds have passed,” said Hannah Khatib, a senior economics major. “For someone who is allergic to many things, including medications, I would want to make sure I don’t have severe adverse reactions.”
Where is the vaccine in the approval process now? According to the Washington Post, the drug will receive FDA approval any day now.
The FDA’s Vaccines and Related Biological Products Advisory Committee has a meeting scheduled for Dec. 10 to discuss granting an EUA to the Pfizer and BioNTech vaccine in order to roll out the U.S. purchased supply. On NBC's The Today Show, James Hildreth, a member of the committee, stated that if the drug is approved by the end of the meeting, vaccinations could be rolled out across the country by Dec. 11. However, the supply of doses available for distribution, if approved, would be limited.
Over the summer, officials of Operation Warp Speed, the public-private partnership working on the development and manufacturing of COVID-19 vaccines, opted to purchase 100 million doses of the Pfizer vaccine instead of the offered 200 million doses due to the lack of FDA approval. Yet, this meant that instead of providing treatment for 100 million Americans, there would only be enough vaccines for 50 million.
“I don’t think I will get a vaccine. It takes years to even create one and I hardly rely on one created in a year. However, I know that the world is currently relying on it,” said Victoria Monsch, a junior economics major. “I don’t belong to the category [of people] that needs it the most right now and we should prioritize [the] sensitive category.”
With FDA approval for the Pfizer and BioNTech drug expected soon, government officials have since reached back out to the company to purchase another 100 million doses of the vaccine. However, on Dec. 8, Pfizer officials told the current administration that the company would not be able to provide the requested amount of COVID-19 vaccinations until June or July due to the high demand from other countries.
“Honestly that [inaccessibility] was one of my worries,” said Khatib. “Scientists and the big vaccine companies believe they will be able to administer a big amount of vaccines in June and from the economic standpoint and from the history of a lot of things being administered, I don’t think that vaccine companies can supply a product (vaccine) to equal the demand that it’s being asked for.”
According to the Center for Disease Control and Prevention (CDC), the U.S. has a limited supply of COVID-19 vaccines and the availability will continue to increase in the coming months. These reported vaccines, however, do not appear to include the one distributed by Pfizer and BioNTech since it has no FDA approval yet.
The U.S. Department of Health and Human Services (HHS) announced on Nov. 23 that an "investigational" anti-viral antibody therapeutic treatment produced by Regeneron Pharmaceuticals had received an EUA from the FDA. The antibody treatment is permitted to be administered only to “non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.”
The CDC has also assured that the cost of the vaccine will not be an issue in the upcoming months. It will be covered by U.S. taxpayer dollars and all administrative costs can be covered by individuals’ insurance companies. For those without insurance, the Health Resources and Services Administration’s Provider Relief Fund will cover any extra costs.
There are currently over 15 million confirmed COVID-19 cases in the U.S. with a 201,756 average increase per day over the past week.
“The world is desperately trying on the pharmaceutical industry now. As cases rise dramatically, they have no other option than starting to get people vaccinated by now. The economy and the lives of many depend on it,” said Monsch. “But what matters right now is December not June.”