Third COVID Vaccine on the Cards as FDA Panel Unanimously Recommends J&J’s Single Shot Candidate

February 26th, 2021 – Johnson & Johnson has received endorsement from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its single-shot COVID-19 vaccine, Ad26.COV2.S. The panel that convened today unanimously voted 22 to 0 in favor of approving the vaccine for emergency use in people 18 and older.

Dr. Archana Chatterjee, one of the members, explained her vote in favor by emphasizing that despite the concerns raised about the vaccine, we are still in the middle of a deadly pandemic, and there is a shortage of authorized vaccines. In her view, the approval of Ad26.COV2.S will help meet the need of the moment.

Now, the FDA will consider the recommendation and decide whether to grant emergency use authorization (EUA). The decision is expected as soon as this weekend or early next week. If the EUA is granted, J&J’s vaccine will become the third vaccine to receive emergency approval in the US. It is worth noting that a EUA is not a full approval as 6 months of data are necessary; however, it will allow people to start receiving the vaccine.

The Biden administration said it plans to ship almost 4 million doses of the vaccine immediately after EUA is granted. However, this is below the 10 million J&J had promised by the end of February. Earlier this week, in a hearing for the House Energy & Commerce Committee, Dr. Richard Nettles, Johnson & Johnson subsidiary Janssen’s vice president of medical affairs, said that they will have 20 million doses by the end of March.

The efficacy of J&J’s vaccine was determined by a Phase 3 trial that enrolled almost 44,000 people across the US, Latin America, and South Africa. The trial showed the vaccine is 100% at preventing hospitalizations and deaths, 66% effective in preventing moderate to severe COVID-19, and 85% effective at preventing severe disease.

Importantly, J&J’s vaccine was protective against the B.1.351 variant first observed in South Africa, which is more contagious, and not effectively curbed by current antibody treatments. Additionally, J&J’s vaccine offers significant logistical advantages since it can be stored at 2˚C to 8˚C, and it requires just a single shot. It is also important to point out that J&J will not profit from their vaccine. They pledge to sell it on a not-for-profit basis.

The vaccine will continue to be monitored over the following months with an emphasis on severe allergic reactions, as two cases were reported. Additionally, in some cases, Bell’s palsy was reported, but they were not significantly different from the overall population.

Although the previously approved mRNA vaccines — the ones from Pfizer/BioNTech and Moderna registered 95% efficacy, they were reported to offer weaker protection against the B.1.351 variant. Besides, they require two-dose vaccinations and must be stored at freezing temperatures. J&J’s vaccine is now likely to join the list of EUA vaccines, adding to the US war chest against COVID.

Related Article: FDA Staff Endorses J&J’s Single-Shot COVID Vaccine, Advisory Committee to Convene on Friday

Author

Daniel Ojeda