The United States now has a COVID-19 vaccine approved for emergency use, which means the next major hurdles are getting the vaccine to front-line health care workers and residents of long-term care facilities. That could begin as early as Monday in Utah.
Calling it the “first big break” in this pandemic, the Centers for Disease Control and Prevention’s advisory group voted Saturday afternoon to recommend that Pfizer/BioNTech’s mRNA COVID-19 vaccine be given to “persons 16 years of age and older in the U.S. population under the FDA’s emergency use authorization.”
“I do believe that the process that we have used here in the ACIP to reach this decision is transparent, science-based, with equity in mind and is for this moment, the offered best that we can do,” said Dr. Beth Bell, chairwoman of the COVID-19 Vaccines Work Group for the Advisory Committee on Immunization Practices, the group tasked with evaluating vaccines and making recommendations to the CDC. The CDC is expected to accept their recommendation soon.
“I can say quite confidently that yes, I certainly will take this vaccine when I’m able and I would give it to my family members,” she finished, after the unanimous vote of 11 (with three recusals).
This vote fits within the advisory committee’s earlier recommendation that the first doses of the limited vaccine supply go to front-line health care workers and residents of long-term care facilities.
The committee also voted to update the CDC’s 2021 vaccine schedule to include COVID-19 vaccines for adults, adolescents and children because after 15 days from being added, insurance providers must cover vaccine fees. By generically listing “COVID vaccines,” rather than Pfizer/BioNTech’s specifically, it will cut out additional delays as subsequent COVID-19 vaccines are developed.
However, numerous experts pointed out Saturday that despite billions being poured into vaccine development, which was successful, “the funding necessary for state and local health departments to carry out this program has been put in the deep freeze with the vaccine,” said Dr. Jeffrey Duchin, the ACIP liaison representative from the National Association of County and City Health Officials.
Bell called the level of financial discrepancy “shocking” and something that needs to be corrected immediately.
“We are not going to be able to protect the American public if we don’t have a way to deliver the vaccines to them,” she said.
In addition to delivery woes, the country is still riddled with vaccine hesitancy.
One public survey by AP-NORC in May found that 25% of Black Americans and 56% of white Americans said they were definitely, probably or somewhat likely to get a vaccine, while a Pew survey in September found those numbers shifted to 32% of Black Americans and 52% of white Americans, according to a presentation by Dr. Sara Oliver of the CDC Saturday morning. An AP-NORC poll from December found that 27% of Americans are still unsure about a vaccine.
“The fact that they vary means that they are modifiable, this is mutable and that hesitancy for the vaccine is not necessarily entrenched,” said Dr. Peter Szilagyi, a professor of pediatrics at UCLA and voting ACIP member. “What that implies to me is we need a lot of work and optimal communication and outreach to these populations.”
Much of that outreach will require clarifying and answering questions related to the vaccine.
Here are some of the key questions and answers from the advisory committee meeting, based on the most recent data available and ACIP’s discussions:
Should pregnant women get this vaccine?
The ACIP recommended that a pregnant woman be allowed to choose if she wants to receive the vaccine, and encouraged her to talk with her health care provider about it. A woman should weigh the issues of COVID-19 spread in her community and her potential risks of contracting COVID-19 and the potential for personal complications or preterm birth, with the fact that there is no data yet on Pfizer/BioNTech vaccine use in pregnant women.
There are 23 women who have become pregnant since being vaccinated in Pfizer’s large Phase 2/3 study who will continue to be monitored, and Pfizer is also conducting developmental and reproductive toxicity (DART) studies to answer questions regarding vaccine safety for pregnant women.
Dr. Linda O. Eckert, ACIP liaison from the American College of Obstetricians and Gynecologists, said their group is looking forward to additional DART studies, but after an early Saturday phone call with CDC and experts in placental pathology and immunology they feel comfortable with the recommendation that allows women the choice, and plans to release guidance for clinicians as early as next week.
What about women who are breastfeeding or who just had a baby?
Similar to the discussion about pregnant women, there are no studies yet on women who are breastfeeding or recently postpartum, but because the Pfizer/BioNTech is not a live vaccine, ACIP saw no reason why pregnant women should not be able to choose whether or not to receive the vaccine.
Should people with underlying medical conditions get this vaccine?
Yes. Pfizer’s 2 /3 clinical trial data show that the vaccine is safe and effective in those with underlying medical conditions such as obesity, chronic pulmonary disease or diabetes. As with all medical decisions, individuals are encouraged to speak with their health care provider.
What are the side effects of this vaccine?
The most common side effects of Pfizer/BioNTech’s vaccine are fatigue, headache, muscle pain and chills — and they were more commonly reported following the second dose.
People ages 16 to 55 were also more likely to report responses to the vaccine than individuals older than 55 during the phase 2/3 trial.
What about people with allergies?
The ACIP recommended that any person who is severely allergic to any component of the vaccine not get it. However, the committee is still working to fine-tune exactly what allergies might put someone at risk. At this point, the consensus was that anyone who had experienced a severe anaphylactic reaction to any vaccine in the past shouldn’t get it, or at least have a lengthy discussion with their provider and receive the vaccine in a place where emergency medication could be administered.
Do I have to get both doses?
Yes. Two doses are required to achieve high efficacy, and health care providers should remind their patients about the importance of coming back for the second dose, which should be given as soon as possible after 21 days following the first dose, but up to 42 days later.
Is the vaccine OK for children?
At this point, the vaccine is only indicated for those 16 years old and older, despite some debate back and forth as to whether 16- and 17-year-olds should be lumped in the same category as 18- to 25-year-olds. Many of the advisory committee members were in favor of including the older teens because many 16- and 17-year-olds work in front-line jobs and are at risk of both contracting COVID-19 and spreading it.
Pfizer indicated Friday that they are currently enrolling 12- to 15-year-olds in another study with a goal of enrolling 2,000 and from there, they’ll study dosing for 5- to 11-year-olds.
Can I get COVID-19 with other vaccines?
While individuals may have fallen behind on other routine vaccinations during the pandemic, the ACIP noted that the Pfizer/BioNTech vaccine should be administered alone —not with any other vaccines or shots, including an influenza vaccine. It should also be spaced out 14 days from any other vaccine.
Will I still need to wear a mask if I get vaccinated?
Yes. Protection from the vaccine will take several weeks to become fully effective and because no vaccine is 100% effective, it is possible that someone who is vaccinated may still get COVID-19. Mask-wearing, social distancing, hand hygiene and continued quarantining when exposed to COVID-19 will still be important for a long time.
Does the vaccine prevent asymptomatic spread?
At this point, scientists still don’t know if the vaccine prevents asymptomatic spread. That is a topic of ongoing studies.
I’m a doctor, where can I get more information to counsel my patients?
Visit the CDC’s provider tool-kit website for more information.