FDA Approves Moderna and J&J Booster Shots, Mixed Booster Doses OK
On October 20, 2021, the U.S Food & Drug Administration (FDA) approved both the Moderna and the Johnson & Johnson booster doses for protection against COVID-19 in eligible populations under Emergency Use Authorization (EUA). The Moderna booster dose is half of the dose given in the primary series.
Additionally, the FDA approved the use of mix-and-match booster doses, meaning that individuals can receive a different type of booster from the original vaccine they received. “The FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations,” the press release explained.
Dr. Janet Woodcock, acting FDA commissioner, also pointed out to USA Today that allowing people to mix-and-match booster doses provides “flexibility” and could let people choose a different type of vaccine from the one they originally had. For instance, if they want to avoid a certain side effect associated with one type or if they have a preference for a certain kind of booster, the heterologous (or “mix-and-match”) dose can allow for that. Furthermore, it also increases availability of booster shots. For example, if a specific vaccine is not available at the time, individuals can still get the booster.
Who Can Get the Booster?
In their press announcement, the FDA outlined the guidelines for the use of the Moderna and the Johnson & Johnson booster. They noted that:
The Moderna booster can be given at least 6 months after the completion of the original 2-dose vaccine series if you:
- Are 65 years or older
- Are 18-64 and at high risk of severe COVID-19
- Are 18-64 with “frequent institutional or occupational exposure” to the virus
The same guidelines apply to the Pfizer-BioNTech COVID-19 booster dose. On the other hand, Johnson & Johnson booster shot can be given to anyone ages 18+ who completed the original single-dose vaccine.
And finally, the FDA approved the use of heterologous booster doses, meaning that, depending on what’s available, you can use a different type of booster from the original type of vaccine you received––as long as you completed the primary series in the appropriate time frame (2 months for Johnson & Johnson and 6 months prior for Moderna or Pfizer-BioNtech).
The New York Times reports that while the FDA hasn’t yet officially released guidance on the preferred formula, it’s expected they will recommend that you try to get the same type of booster as your original vaccine series, but if it’s not available, to get a different available booster. If you meet the eligibility for the booster doses, you can get a booster dose immediately as soon as it is available.
Booster Safety + Efficacy Data
According to the FDA’s announcement, they analyzed safety and efficacy data, including immune response and side effects. For the Moderna vaccine specifically, the FDA explained it analyzed immune response data from 149 participants (who were all over age 18) who got the booster and compared that data to 1,055 participants who were fully vaccinated but did not receive the booster.
The analysis showed what the FDA called a “booster response” 29 days after the booster dose was given. They also found that, based on the Delta surge rates of infection over summer 2021, vaccine effectiveness does decrease over time.
Safety evaluation for the Moderna vaccine was based on 171 participants, all over the age of 18, who were followed for an average of about six months following the booster. They found no significant safety signals that differed from the original vaccine series; however, they did find a higher incidence of swollen lymph nodes in the underarm of the side the vaccine was given in with the booster vs. the regular vaccine series.
The Johnson & Johnson vaccine booster dose was also based on a relatively small sample size. The FDA evaluated the immune response data from 39 participants (24 who were 18-55 and 15 who were 65+). Their results also demonstrated a booster dose was effective.
The safety data for Johnson & Johnson was based on much larger sample sizes; however, over 9,000 clinical trial participants received a booster dose at least two months from the first and of those, 2,700 have been followed for two months. According to the FDA, “Janssen’s safety analyses from these studies have not identified new safety concerns.”
What are the Risks of the Booster?
Aside from the swollen underarm lymph nodes that were seen more with the booster, there were no other different side effects or risks reported by the FDA. They did not have the side effects for each booster, which are in line with the primary vaccine series as well.
The side effects for the Moderna booster included:
- increased risks of inflammatory heart conditions, myocarditis and pericarditis, especially following the second dose and most often in men 18-24 and most often developing only a few days after vaccination
- muscle and/or joint pain
- nausea and vomiting
- pain at the injection site
- swollen lymph nodes in the same arm as the injection
The Johnson & Johnson booster dose carries the same risks as the primary vaccine dose, which are:
- Increased risk of Guillain Barré syndrome within 42 days of receiving the vaccine
- TTS, with symptoms beginning 1-2 weeks after vaccination and most often in females 18-49
Should You Get the Booster?
If you’re already fully vaccinated against COVID-19 and aren’t at high risk, the best thing you can do is talk to your doctor about if you should receive a booster dose. While the data does show that there is waning immunity after all types of vaccination, it’s also important to understand that waning immunity is actually not only normal after a vaccination, it’s also important.
As an article in the Atlantic explains, waning immunity actually signifies that the vaccine is working as it’s supposed to. Following an initial flurry of activity, primarily from the less-sophisticated B cells, eventually, the immune system slows down the production of general antibodies and produces more targeted and sophisticated antibodies. In other words, your immune system might produce fewer antibodies against COVID-19 over time, but chances are, those antibodies will also be a whole lot more effective in fighting the virus should you encounter it.
So, in individuals whose immune systems are working as they should, it might boil down to being more about quality, not necessarily quantity. However, that’s a big “if” and you should talk to your doctor about your own risks and if a booster might be right for you.
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