On Thursday, a key committee of outside experts recommended the US Food and Drug Administration (FDA) issue an Emergency Use Authorization for Pfizer’s coronavirus vaccine.
That doesn’t mean the vaccine is approved today, but the FDA is expected to follow this committee’s advice. Should the agency do so, some Americans could start getting the shots just days from now.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC), faced one major question: Do the benefits of the Pfizer vaccine outweigh the potential risks for people 16 and older?
After a day of presentations and intense discussion, the group voted to recommend that the vaccine receive an EUA by a margin of 17 to 4 (with one member abstaining).
The group had an intense discussion over whether to recommend the vaccine for 16 and 17-year-olds, the youngest age group in the Phase 3 trial. The issue was fraught enough for some scientists to consider voting against the vaccine, but it was eventually passed. The FDA may take that discussion into account, and raise the age limit if it issues an EUA based on that advice.
"We very much appreciate their input on this very important topic and we will take what we heard today into consideration when deciding on not only the EUA issuance here, but also how to move on in the development of the product," said Marion Gruber, director of the FDA's Center for Biologics Evaluation and Research.
Results from Pfizer’s Phase 3 trial, indicated the vaccine was 95 percent effective in preventing Covid-19. The process involves getting two shots, 21 days apart. However, data presented at the meeting suggests that the vaccine may be partially effective after just one dose, with immunized people showing better protection compared to placebos after 14 days.
When a vaccine gets an EUA, it doesn’t mean it has full approval. Given the extreme circumstances we’re under, the expert panel deemed the vaccine safe and efficacious enough to mollify the current crisis for now. The US broke its record for daily deaths on Wednesday, with 3,124 recorded.
This recommendation, a crucial step in the FDA’s gold standard approval process, is a major indication that the vaccine will soon be rolled out in the US.
Below is what the advisory committee, the CDC, and Pfizer had to say about three key questions about the Covid-19 vaccine.
3. When will we be able to get the vaccine?
Thursday’s vote can’t get the trucks rolling just yet. Instead, their recommendation is taken to the FDA, which could issue the EUA as early as tomorrow, though it could be dragged out into next week.
Once the FDA issues the EUA, shipping could get underway as soon as the next day, sending 2.9 million vaccines rolling toward all 50 states, according to comments made by Gustave Perna, the chief operating office for Operation Warp Speed.
The CDC’s Advisory Committee on Immunization Practices offers a recommendation as to who gets the shots first. In guidance issued December 1, we learned that healthcare workers and workers in long-term care facilities should get the vaccine first.
Pfizer’s fact sheet says that it will start shipping vaccines by road and air from sites in Michigan, and Wisconsin, with the expectation that they’ll reach any location “within a day or two.”
It won’t be easy. Pfizer vaccine has to be kept at an extremely low temperature while transported (between -80 and -60 degrees celsius, or -94 Fahrenheit.). Pfizer has created special coolers that can aid in transport, but there have to be appropriately cold storage facilities once the vaccine gets where it’s going.
Facilities can keep vaccines for six months in specialized freezers, for 30 days in Pfizer’s coolers, and for five days in a regular fridge. But once unfrozen, they must be used within six hours.
To complicate things, the smallest possible batch of vaccine that can be ordered is 975 doses of vaccine, pointed out Anita Patel, a member of the CDC’s Vaccine Task Force. That volume could dictate what actual distribution sites (hospitals, clinics etc.) where the vaccine is actually delivered.
“This has posed challenges, especially in rural areas of the country where that volume of product is more difficult to manage,” Patel said Thursday.
2. How safe is the vaccine?
The most commonly reported side-effects of Pfizer’s coronavirus vaccine included fatigue, headache, muscle pain, chills, joint pain, and fever. These effects were more common in people younger than 55, which is expected due to the strength of younger people's immune systems, Inverse previously reported.
Two adverse events that the agency believes were possibly linked with the vaccine include one shoulder injury and 64 cases of temporary swelling in the lymph nodes, compared to 6 in the placebo group.
1. Does it cause allergic reactions?
The FDA will also keep an eye on reports of two reactions to the vaccine from people with a history of severe allergies in the UK. During the discussion section, scientists raised concerns over whether Pfizer's trial included individuals with a history of severe allergies.
Gruber said the FDA has been in contact with the UK over these cases. The FDA plans to include a fact sheet with the vaccine stipulating that anyone with allergies to any components of the Pfizer vaccine not receive it. But that doesn't address the UK's recommendation that those with severe allergies not receive it.
Paul Offit, the Director of the Vaccine Education Center at Children's Hospital of Philadelphia, called for more research on this topic but agreed that this should not hold up the recommendation of an EUA.
"I just think it's a practical solution because this is not going to die. This issue is not going to die until we have better data," he said.
Other experts have indicated that allergic reactions to vaccines aren't unheard of. "Lots of vaccines are associated with allergic reactions in some small percentage of the population,” William Schaffner, infectious disease specialist at the Vanderbilt University Medical Center.
However, by recommending an EUA, this advisory group argues that the risks of the vaccine pale in comparison with the benefits of protecting against Covid-19, a disease that can assault organs throughout the body, and cause long-term effects.
In addition to existing tools for reporting complications, the CDC is rolling out a new way to report issues with the vaccine, called “V-safe.”
Nancy Messonnier, the director of the National Center for Immunization and Respiratory Diseases, described V-safe as an “active surveillance tool" that uses text messages and online surveys to help detect adverse events from those who get the vaccine.
Participants who choose to opt-in to v-safe will fill out monthly surveys for a year post-vaccination. If they report some medical event that requires them to seek medical attention or disrupts their daily lives, they’ll get a followup call from the CDC.
“We really need people to sign on to the system to give us the best data possible,” Messonnier said.
What’s next? – The issuance of an EUA will not mean clinical trials will stop. In fact, it highlights that these trials should continue, and justifies the creation of even more studies.
To start, Pfizer has proposed three followup studies that monitor complaints related to the vaccine from healthcare workers, US military members, and US veterans.
The dream is that the vaccine would eventually receive full approval outside of the Emergency Use Authorization, which would require more safety monitoring, and for clinical trials to keep pushing forward for months as the vaccine is rolled out at the same time.
Pfizer plans to file for official approval of the vaccine by April 2021.