U.S. COVID-19 Booster Shot Strategy Becomes Clearer
The differing guidance about who can get a booster shot to protect against COVID-19 has left many of our patients wondering whether they’re eligible to receive a third dose (or a second one, for those who got the Johnson & Johnson vaccine).
Our primary care doctors have been closely following the government’s decision-making process regarding the approval of booster shots. It now appears all the agencies involved have finally reached a consensus.
Here’s what we know now.
Pfizer-BioNTech booster shot approved
Late last month, the U.S. Food and Drug Administration (FDA) amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to be administered at least six months after completion of the primary series.
If you fall into the following categories and have received the initial two-dose regimen of the Pfizer-BioNTech coronavirus vaccine, you may receive an additional dose:
- are age 65 and older
- at high risk of contracting a severe case of COVID-19 and age 18-64
- are age 18-64 and your job frequently exposes you to the possibility of contracting COVID-19
The latter category applies to such occupations as those who live or work in:
- the health care field
- meatpacking plants
- grocery and other such stores
- schools or daycare centers
- long-term care facilities
- homeless shelters
- any place that you might regularly encounter a high level of the SARS-CoV-2 virus that causes COVID-19.
Behind the decision
The Centers for Disease Control and Prevention (CDC) quickly endorsed the FDA action. This overrules its Advisory Committee on Immunization Practices (ACIP). The ACIP had recommended against authorizing a booster shot for anyone under the age of 65. The FDA’s own advisory panel likewise recommended against a third dose at this time. It cited gaps in the data that supposedly demonstrate the need for widespread booster immunization.
They argued that the vaccines currently available continue to provide strong protection against hospitalization and death. This was the original aim of the vaccines. Several stressed that the best way to curb the pandemic and provide protection is to have more people receive their first vaccines.
“This was a scientific close call,” CDC director Rochelle Walensky told reporters at a White House briefing on her decision. “In that situation, it was my call to make.”
The CDC explained that several studies have indicated that the effectiveness of the vaccine against infection and hospitalization has declined for many of those who received it early on. However, the agency said that rates of COVID-19 remain much higher for those who haven’t received the vaccine at all.
“This updated interim guidance from CDC allows for millions of Americans who are at highest risk for COVID-19 to receive a Pfizer-BioNTech COVID-19 booster shot to help increase their protection,” the agency said in a statement.
Others must wait
If you don’t fall into one of the above, you won’t yet be able to receive a third dose of the Pfizer vaccine.
In addition, both the FDA and CDC authorizations apply only to those who have received the two-dose Pfizer regimen. Those who have gotten the Moderna and Johnson & Johnson vaccines will have to wait for specific authorizations for an additional booster dose.
Moderna only recently submitted their data to the FDA requesting approval for a third dose. It will be several weeks before a decision is made on that vaccine. Unlike Pfizer, which plans to administer the same amount of vaccine as contained in its first two doses, Moderna is only requesting approval for half its original doses. This is 50 mcg. vs. 100 mcg.
Johnson & Johnson, meanwhile, while maintaining that their single-shot vaccine still offers 79 percent protection against infection and 81 percent protection against hospitalization for up to eight months, released updated results of their latest studies. These showed that a second dose at least 56 days after the first dose increased protection against COVID-19 infection to 95 percent.
Researchers at the National Institutes of Health (NIH) have been conducting trials to determine whether it’s safe to mix the two types of mRNA vaccines (Pfizer and Moderna) or an mRNA vaccine with the Johnson & Johnson vaccine. Expect results within days.
First shots are crucial
Amid all the discussions about booster shots, though, we want to urge those who haven’t yet had an initial vaccine to get it: either the two-dose Pfizer or Moderna vaccine or the single-dose Johnson & Johnson vaccine.
At this point, only about 55 percent of eligible Americans are fully vaccinated. Every time the virus infects someone, it has an opportunity to mutate. A mutation may eventually be able to evade the vaccines.
Both President Biden and Senate Minority Leader Mitch McConnell (R-KY) received booster shot doses late last month.
“Mountains of evidence tell us these shots are safe, effective, and dramatically shrink the odds of severe disease or death from COVID,” McConnell said. “These safe and effective vaccines are the way to defend ourselves and our families from this terrible virus. They’re also how we stay on the offense against COVID as a country.”