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Single-Dose Vaccine Update: Efficacy and Potential Timeline

Single-Dose Vaccine Update: Efficacy and Potential Timeline
COVID-19

A few weeks ago, we discussed exciting interim data published regarding trials for Johnson & Johnson’s “single-dose” vaccine, which showed promise as a new tool in the fight to contain Covid-19. We now have updated information from Johnson & Johnson (“J&J”), who published new Phase III trial information just days ago.

Efficacy Rates

The J&J single-dose vaccine shows lower effectiveness when compared to those of Pfizer-BioNTech and Moderna (as expected). Specifically, the J&J Vaccine’s efficacy rates are reported as follows:

“Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe Covid-19,” and

“85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against Covid-19 related Hospitalization and Death as of Day 28”

(See “Johnson & Johnson Announces Single-Shot Janssen Covid-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial”) (emphasis added)

What it Means

While the efficacy rates are certainly lower than Pfizer-BioNTech and Moderna’s two-dose vaccines, there are several important factors to consider here, including the following: first, the J&J vaccine has shown it can establish an immune response after only one dose. The United States has faced significant issues regarding distribution, storage, and scheduling of the alternative vaccines. Having a single-dose vaccine will help people get vaccinated quicker. And it won’t require people schedule and keep follow up appointments.

Second, as previously discussed, the J&J vaccine is more easily stored (for months at refrigerator temperature), which aids storage and distribution efforts. It can be more easily transported and stored, meaning it can get to places/areas the other vaccines can’t.

Third, for the range of moderate to severe Covid-19, the vaccine is 72% effective in the US. That is still an excellent figure, especially considering most vaccines (e.g. – annual flu vaccines) aim at >50% efficacy. However, even more exciting is that for severe Covid-19, the J&J vaccine is 85% effective and offers complete protection against hospitalizations and death. This complete protection was demonstrated with all variants, from the UK to South Africa.

As Dr. Fauci and other medical experts have suggested, the single-dose vaccine is extremely promising, and it approved and out for distribution could save millions of lives. (See, e.g. “Johnson & Johnson’s lower-immunity single-dose COVID vaccine might be just what the doctor ordered”; see also, Fauci: Covid Vaccines are Less Effective Against New Strains—But Still Worth Taking.

What’s the Timeline?

According to J&J, the company will file for emergency use authorization in early February and expects to have product available to ship immediately following authorization. That means that J&J could receive FDA clearance as soon as this month.

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Single-Dose Vaccine Update: Efficacy and Potential Timeline

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