A J&J spokesperson said yesterday that it is collecting more data on whether a booster shot is necessary.
Daniel Karmann/picture alliance via Getty Images
On August 12, the U.S. Food and Drug Administration (FDA) amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to include a third shot for immunocompromised patients. And as reported on August 17, there are indications that the FDA will recommend a third COVID-19 vaccine booster for the rest of the population eight months after receiving the Moderna or Pfizer-BioNTech shots. The Biden administration is expected to address the question during a COVID-19 briefing today.
However, there’s still an open question: What about the 14 million people in the U.S. who received the single-shot Johnson & Johnson vaccine? At this time, they do not appear to be part of the discussions over boosters.
Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, told CNN, “Our J&J patients have not been overlooked or neglected. It’s just the way the data are coming in. You can’t make good recommendations without the data.”
Consistent with the data regarding the Moderna and Pfizer-BioNTech mRNA vaccines, J&J announced in July that their Janssen vaccine offers immunity for at least eight months, potentially longer. It also seems to provide adequate protection against the Delta variant, which is now the dominant strain in the U.S., and significantly more infectious than the original Wuhan wildtype strain or even the first major variant, the U.K. strain.
The data about the mRNA vaccines have primarily come out of Israel, which exclusively used the Pfizer-BioNTech vaccine, and studies by the Mayo Clinic. Those studies suggest that the vaccine protection tends to wane, particularly to the Delta variant. They still protect from severe disease and death, but they may not be as effective for mild to moderate infections and asymptomatic infections over time.
Israel’s Ministry of Health data showed that the Pfizer-BioNTech vaccine protection dropped sharply after six months, from about 95% to 40% to 50%. Although there is no evidence yet, Eric Topol, vice president for research at Scripps Research in La Jolla, Calif., thinks the three-week interval of the two-dose Pfizer-BioNTech shots may not be enough time for the immune system’s memory B and T cells to develop as strongly as they would with a longer interval. The Moderna vaccine shot interval is four weeks.
“This might not have happened if the spacing had been 8 to 12 weeks,” Topol said. “That’s what Canada, the United Kingdom and Scotland did.”
Pfizer-BioNTech has already submitted Phase I data to the FDA in support of the third booster shot. They also plan to present the data to the European Medicines Agency (EMA) and regulators worldwide in the next few weeks.
A J&J spokesperson told CNN yesterday that it is collecting more data on whether a booster shot is necessary.
“Ensuring long-term and durable protection against hospitalization and death are critical in curbing the COVID-19 pandemic,” the company told CNN. “Johnson & Johnson continues to diligently generate and evaluate evidence from ongoing trials as well as emerging real-world evidence as it assesses the need for a booster of the Johnson & Johnson COVID-19 vaccine.”
Many vaccines require boosters. The tetanus shot, for example, requires a booster approximately every 10 years because immunity drops. The flu shot requires yearly adjustments for new strains. The shingles shots are typically two shots given six months apart.
The only way to determine how long a vaccine’s effectiveness lasts is to monitor it over time, and with COVID-19 vaccines that only began dosing clinical trials in 2020, the long-term data is missing, although it’s now starting to come in.
Unlike the Moderna and Pfizer-BioNTech vaccines, which utilize tiny lipid particles containing messenger RNA to encode for a piece of the SARS-CoV-2 spike protein, the J&J vaccine uses a genetically engineered cold virus as a vector for a section of genetic code for the virus. The infected cells then churn out the protein that trains the immune system to recognize the virus.
Although the Moderna and Pfizer-BioNTech vaccines were authorized in December 2020, the J&J vaccine was still gathering data and received its EUA in February 2021.
It’s still unclear if immunocompromised people who received the J&J vaccine would benefit from a booster shot.
The U.S. Centers for Disease Control and Prevention (CDC) told CNN, “We have been reviewing the science and data on a near-daily basis to evaluate whether or when boosters may be needed. As we have been saying, boosters will probably be needed. We will be announcing more detailed plans soon, so we’ll have more to share then. This will all be done in accordance with independent FDA and CDC review and recommendations.”
At this time, in the U.S., there are no recommendations for people to mix and match vaccines. In other words, if you received the J&J vaccine, for example, getting a booster of the Pfizer-BioNTech or Moderna vaccine is not recommended at this time. Mixing vaccines has been the policy in Germany, and data has suggested the mix is safe and creates a robust immune response. In the U.S., San Francisco’s Department of Public Health made an “accommodation” for people who received the J&J vaccine who consulted with their doctor to get a supplemental mRNA vaccine dose. However, that is not in place elsewhere in the U.S.
