J&J’s Now-approved Vaccine Propels Equitable Distribution

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With the approval of Johnson & Johnson’s COVID-19 vaccine candidate over the weekend, the U.S. is inching closer to mass vaccination, while the World Health Organization (WHO) works to ensure equal access for lower-income countries.

After filing for Emergency Use Authorization (EUA) on February 4, the FDA granted approval Saturdaynight to the Janssen COVID-19 vaccine candidate. Unlike Pfizer and Moderna’s vaccines, this vaccine only requires a single dose.

In addition to simplifying the vaccination process for people, a single-dose treatment cuts manufacturing needs in half. The pharmaceutical company said it expects to supply 100 million doses to the U.S. in the first half of 2021—which is enough to vaccinate 100 million people, as opposed to 50 million.

The U.S. may have been the first to approve the Janssen COVID-19 vaccine, but global approvals are likely on the horizon.

On February 16, J&J submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA). Three days later, the pharma giant completed a rolling submission of clinical data to WHO, officially submitting an application for Emergency Use Listing (EUL). Decisions and/or approvals are expected from both entities in the near future.

WHO’s EUL process is a prerequisite to supply vaccines to the COVAX facility. COVAX, which is coordinated by the non-profit Gavi, is a global pooling program that ensures equal access to vaccines for all nations, regardless of wealth.

In December 2020, J&J entered into an advance purchase agreement with COVAX that will send 100 million doses of their approved vaccine candidate this year. Additionally, Gavi has the option to order another 100 million doses before year’s end, and up to 300 million doses next year—a combined total of up to 500 million doses through 2022.

Currently, WHO has approved the Pfizer/BioNTech vaccine as well as two versions of the AstraZeneca/Oxford University vaccine. On February 23, COVAX shipped 600,000 doses of the AstraZeneca vaccine candidate to Ghana, marking the beginning of the program’s global roll-out. Additionally, Gavi said they expect to finalize the first round of allocations for doses of the two approved vaccines in the coming days, meaning available doses will be shipped the majority of countries participating in COVAX on a rolling basis.

At this time, 190 countries have joined the COVAX Facility, including 92 low- and lower-middle-income countries. Then-president Donald Trump refused join COVAX in September 2020, but President Joe Biden has shown support for the facility. Last week, Biden announced that the U.S. will provide an initial $2 billion contribution to Gavi, with an additional $2 billion through 2022 as other donors fulfill their pledge and initial doses are delivered.

J&J’s vaccine and the Phase 3 ENSEMBLE trial

Data from the Phase 3 ENSEMBLE clinical trial shows the COVID-19 vaccine developed by Janssen Pharmaceuticals is safe and 66% effective at preventing moderate and severe COVID-19 in adults. The analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. The investigational vaccine was 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant.

Geographically, the level of protection for moderate and severe disease varied—72% in the United States; 66% in Latin American countries; and 57% in South Africa (all 28-days post-vaccination). According to trial results, the investigational vaccine was 85% effective in preventing severe/critical COVID-19 across all geographical regions.

No deaths related to COVID-19 were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19. Overall, there were 16 deaths in the placebo group, and 3 deaths in the vaccine group. No severe side effects were recorded.

The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein. In developing the vaccine, Janssen employed the same vector used in the first dose of its prime-boost vaccine regimen against the Ebola virus.

The single-dose vaccine can be delivered and stored for up to three months in a standard refrigerator at temperatures +2° to +8° C.

Photo credit: J&J