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FDA on Wednesday authorized booster doses of the Moderna and Johnson & Johnson Covid-19 vaccines and allowed Americans to switch vaccine brands for their booster.
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FDA authorizes 'mixing and matching' vaccines for boosters
In a statement, FDA said that, for individuals who previously received a two-dose series of the Moderna vaccine, a half-dose booster can be given six months later. Meanwhile, for those who initially received a single dose of the J&J vaccine, a booster can be given two months later.
"The available data suggest[s] waning immunity in some populations who are fully vaccinated," acting FDA Commissioner Janet Woodcock said. "The availability of these authorized boosters is important for continued protection against Covid-19 disease."
The agency also said that anyone who's eligible to receive a booster dose could receive any currently authorized Covid-19 vaccine for their booster.
So far, research suggests switching Covid-19 vaccines is safe and effective. For example, a recent study from NIH found that boosters of all three authorized Covid-19 vaccines generated a strong immune response, with the vaccines from Moderna and Pfizer-BioNTech leading to larger increases in antibody levels than the J&J vaccine.
Vaccine mixing may help simplify the booster rollout
According to the New York Times, state health officials have been requesting an option to mix and match vaccines, arguing it would simplify the booster rollout.
"The No. 1 thing I heard from state health secretaries was the need for permissive language around a mix-and-match approach," said Nirav Shah, Maine's top health official and the president of the Association of State and Territorial Health Officials.
According to the Times, switching vaccine brands can be helpful if patients had adverse reactions to their initial vaccines or if providers do not have access to a patient's original vaccine. For example, Clay Marsh, West Virginia's Covid-19 czar, said the state had a greater supply of Moderna and Pfizer-BioNTech vaccines than J&J.
"Being able to interchange these vaccines is a good thing—it's like what we do with flu vaccines," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research. "Most people don't know what brand of flu vaccine they received."
In addition, other health officials said the option to switch vaccines could streamline the administration of boosters, the Times reports, since providers would not have to match patients to their initial vaccine brands first.
What's next?
On Thursday, CDC's Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending booster shots of Moderna's and J&J's vaccines to CDC Director Rochelle Walensky, who has the authority to issue final recommendations.
In September, ACIP recommended boosters for some populations but did not support them for those whose jobs put them as risk of exposure to the coronavirus. Walensky, however, ultimately decided to recommend boosters for those populations.
Given that prior disagreement, "[i]t is going to be a difficult meeting, because I suspect that the science won't have changed much," said Sarah Long, a pediatrician and infectious disease expert at Drexel University. "I can see making it clear that we still don't think this is the right approach, and Dr. Walensky would have to override it."
According to federal health officials, ACIP is likely to recommend patients receive a booster shot of the same brand as their initials series but will allow mixing and matching of vaccines if that isn't possible. (LaFraniere/Weiland, New York Times, 10/21; Branswell/Herper, STAT News, 10/20; Chen, Axios, 10/20; Perrone/Neergaard, Associated Press, 10/21; Loftus/Schwartz, Wall Street Journal, 10/20; Walker, MedPage Today, 10/20; Jeong et. al., Washington Post, 10/21; Gardner, Politico, 10/20; Weixel, The Hill, 10/21; Joseph/Branswell, STAT News, 10/21; Mandavilli, New York Times, 10/21)
5 key considerations as 'mix and match' boosters roll out
By Pamela Divack
The authorization and upcoming rollout of boosters creates many new opportunities and challenges for health care leaders. Be sure to keep these five things in mind as you prepare your vaccine strategy moving forward.
- Communication and education still matter—fully boosting all eligible people will require proactive efforts from all parts of the health care industry.
It's possible that the initial booster rollout may be slow, as people may struggle to understand what the boosters do, why it's important to boost immunity, and whether there are potential side effects. as well as hesitance to take off work or dedicate time to getting the additional shot. Aside from the clinical concerns patients may have, there may also be confusion surrounding eligibility and different mix-and-match regimens.
Additionally, reaching originally hesitant and hard-to-reach populations and convincing them to take a booster—especially for those who originally opted for the J&J one-dose vaccine due to simplicity and convenience—may be a challenge. As we've seen before with initial vaccine doses, there are many 'unvaccinated but willing' individuals who fall short of receiving a shot for various reasons outside skepticism. We anticipate a continuation of this challenge, even with boosters. Successful booster rollout will require proactive outreach efforts and other key steps from all parts of the health care industry.
Despite the positive booster news and authorizations, our best tool to fight the virus is still getting as many people vaccinated as possible. Efforts to roll out boosters should not detract from trying to improve vaccine uptake overall.
- Booster rollout will be complex for administers and distributors—it is essential to develop clear protocols.
The vaccine supply chain is about to get much more complex with Moderna's half-dose booster shot (and full third dose for immunocompromised people), J&J and Pfizer's full third dose, varying dosing interval schedules, the impending authorization of different-dose vaccines for kids, and complexities around mixing-and-matching.
Leaders must develop and implement ways to organize this complexity and track various protocols, account for unpredictable supply and demand of different shots, prepare for an influx of demand if eligibility widens in the coming weeks, and prevent potential waste. They should also prepare for the potential need to dedicate space, resources, or staff to booster clinics, to help more efficiently and easily distribute boosters to those eligible, and clearly communicate what boosters they have available with patients (who may actively seek out specific shots.)
- Mixing and matching makes the vaccinator's job both easier and harder.
This future complexity presents a challenge for individual vaccinators, too. Organizations must ensure their staff are equipped to handle varying dosing regiments, timing intervals, and eligibility criteria for different populations – and keep up with potential eligibility expansion in the future. Tracking various protocols will increase the mental load on vaccinators to ensure they're giving the right dose to the right patient at the right time (especially if booster doses are not shipped in different vials), and staff must be trained and prepared to manage this complexity.
- Providers and regulators must continue to track data on the vaccines, even after booster rollout.
As we push forward in the quest for immunizing the population, we need to keep tracking data to understand a myriad of questions: whether we will need yearly boosters, which vaccine regimens are most effective, optimal timing of vaccination, effectiveness against different variants, and risks associated with different populations, among others.The answers to these questions will likely determine long-term vaccination strategy and pandemic response. The more data available, the less room there is for confusion and misinformation.
- Equity efforts will always be important, especially if we hope to vaccinate the world
We've said this before and will say it again: equity must be embedded into every aspect of the battle against Covid-19. Providers, pharmacies, and clinics must not lose sight of lessons learned during the initial phase of rollout—such as offering boosters at convenient hours, so people don't need to take off work or bringing the shots directly into the community. Review key takeaways from an organization that led a successful and equitable Covid-19 response with the initial vaccine rollout—the lessons still apply to the booster rollout.
While there are more than five considerations in the booster rollout, these are important to think about right now. As we await CDC's final recommendations on boosting and mixing-and-matching, health care leaders need to start preparing for the complexities involved with boosting patients.
Andrew Mohama contributed to this piece
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