People who received a Johnson & Johnson (J&J) coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNTech, according to preliminary data from a US federal clinical trial.
That finding, along with a mixed review by the US Food and Drug Administration (FDA) of the case made by J&J for an authorisation of its booster, could lead to a heated debate about how and when to offer additional shots to the 15 million Americans who have received the single-dose vaccine.
The New York Times reports that the FDA’s vaccine advisers were to meet last week to vote on whether to recommend Moderna and J&J be allowed to offer booster shots.
Some experts predict the agency would clear the shots anyway, as the effectiveness of the one-shot vaccine is lower than that of the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech.
In the US, the Pfizer and Moderna jabs are the most widely used, with more than 170m people fully immunised with either one or the other. When J&J’s was authorised in February, public health experts were eager to deploy the “one-and-done” option, particularly in communities with poor access to health care. But the vaccine’s popularity plummeted when the FDA later paused its use to investigate rare blood clotting cases.
For those who have had the J&J vaccine, the timing of a booster authorisation — of any brand — is still uncertain, adds The New York Times. The FDA panel’s vote was only on whether the agency should permit a second dose of J&J, a scenario the Centers for Disease Control and Preventionʼs own vaccine advisory committee will discuss this week. If both agencies believe an additional dose should be offered, people could seek them out this wee.
In a study conducted by the National Institutes of Health, researchers organised nine groups of roughly 50 people each. Each group received one of the three authorised vaccines, followed by a booster. In three groups, volunteers received the same vaccine for a boost. In the other six, they switched to a different brand.
The antibody levels of those who got a J&J shot followed by a Moderna booster rose 76-fold within 15 days, whereas those who received another dose of J&J saw only a fourfold rise in the same period. A Pfizer-BioNTech booster shot raised antibody levels in J&J recipients 35- fold.
The authors cautioned about the studyʼs small size and noted that they did not follow the volunteers long enough to identify rare side effects.
Heterologous SARS-CoV-2 Booster Vaccinations: Preliminary Report
Robert Atmar, Kirsten Lyke, Meagan Deming, Lisa Jackson, Angela Branche, Hana El Sahly, Christina Rostad, Judith Martin, Christine Johnston, Richard Rupp, Mark Mulligan, Rebecca Brady, Robert Frenck Jr., Martin Backer, Angelica Kottkamp, Tara Babu, Kumaravel Rajakumar, Srilatha Edupuganti, David Dobryzynski, Christine Posavad, Janet Archer, Sonja Crandon, Seema Nayak, Daniel Szydlo, Jillian Zemanek, Clara Dominguez Islas, Elizabeth Brown, Mehul Suthar, M Juliana McElrath, Adrian McDermott, Sarah O'Connell, David Montefiori, Amanda Eaton, Kathleen Neuzil, David Stephens, Paul Roberts, John Beigel
Published in MedRxiv on 15 October 2021
While coronavirus disease 2019 (COVID-19) vaccines are highly effective, breakthrough infections are occurring. Booster vaccinations have recently received emergency use authorisation (EUA) for certain populations but are restricted to homologous mRNA vaccines. We evaluated homologous and heterologous booster vaccination in persons who had received an EUA COVID-19 vaccine regimen.
In this phase 1/2 open-label clinical trial conducted at ten US sites, adults who received one of three EUA COVID-19 vaccines at least 12 weeks prior to enrolment and had no reported history of SARS-CoV-2 infection received a booster injection with one of three vaccines (Moderna mRNA-1273 100-mcg, Janssen Ad26.COV2.S 5×1010 virus particles, or Pfizer-BioNTech BNT162b2 30-mcg; nine combinations). The primary outcomes were safety, reactogenicity, and humoral immunogenicity on study days 15 and 29. Results: 458 individuals were enrolled: 154 received mRNA-1273, 150 received Ad26.CoV2.S, and 154 received BNT162b2 booster vaccines. Reactogenicity was similar to that reported for the primary series. Injection site pain, malaise, headache, and myalgia occurred in more than half the participants.
Booster vaccines increased the neutralizing activity against a D614G pseudovirus (4.2-76-fold) and binding antibody titers (4.6-56-fold) for all combinations; homologous boost increased neutralizing antibody titers 4.2-20-fold whereas heterologous boost increased titers 6.2-76-fold. Day 15 neutralizing and binding antibody titers varied by 28.7-fold and 20.9-fold, respectively, across the nine prime-boost combinations.
Homologous and heterologous booster vaccinations were well-tolerated and immunogenic in adults who completed a primary COVID-19 vaccine regimen at least 12 weeks earlier.
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