FDA VRBPAC Votes in Favor to Recommend EUA of Janssen’s COVID-19 Vaccine

After a day of deliberating on the efficacy of the Janssen’s Ad26.COV2.S COVID-19 vaccine, the VRBPAC voted 22 to 0 to recommend the vaccine be granted an EUA.

This recommendation paves the way for the FDA to decide on whether it will do so, and the decision on the EUA could come as early as tomorrow.

Update, 5 pm: The US Food and Drug Administration (FDA) Vaccines and Related Biologic Products Advisory Committee (VRBPAC) has voted to support the evidential benefit of one-shot Janssen Ad.26.Cov2.S vaccine for the prevention of COVID-19.

The supporting vote from the expert panel precludes FDA decision on the pharmaceutical company's Emergency Use Authorization (EUA) for COVID-19 prevention in adults.

Update, 3:54 pm:

After the open hearing session, data efficacy and safety monitoring were presented. Much of this information was previously presented or was available to read. Questions still remain about the duration of protection and if the vaccines are efficacious against the variants, the FDA presenter stated.

One area of an ongoing concern has been whether the vaccines are safe for pregnant women. Janssen is planning to perform multi-country studies in this patient population this year.

After a short break, members of FDA and Janssen fielded questions from the committee. One member, for example, asked if the single dose would be viewed as effective by the public.

More updates to come.

Update, 2:10 pm:

After the lunch, the open hearing session commenced. This allowed members of the medical community and the general public to offer feedback including their concerns with the vaccines. For example, one physician spoke of his support of an EUA of the Janssen vaccine, but also wanted to expand the EUA to a single-dose administration of both m-RNA vaccines after seeing the data in comparison to the Janssen vaccine.

No clinical studies have been done with pregnant women, explained another medical provider. He said that nothing could be found in terms of if the vaccine could enter into human genomes.

Other medical providers and members of the general public spoke of safety concerns and efficacy of using a single-dose vaccine.

Another concern raised by a physician was lowering the standards of just offering EUAs and not a full approval by the FDA.

More updates to come.

Update, 12:30 pm:

Janssen continues to present its clinical trial data. During its clinical trials, neutralizing antibody titers were elicited in 96% of participants, independent of age.

In the US population, the vaccine showed efficacy of 74%, 14 days after vaccination, and 72% after day 28. And no cases of COVID-19 in the vaccine group after 40 days. Overall, protection across all countries was 66%.

No COVID-19 confirmed deaths were reported in the vaccine group and 7 were reported in the placebo group.

The benefits outweigh known and potential risks, according to Janssen.

A clinical investigator offered his insights. “Getting on top of these variants will be critical,” he said. “Well-tolerated…and highly efficacious.”

More updates to come.

Update, 11:41 am:

A review of vaccine safety of the current m-RNA vaccines was done. Thus far, there has been very few adverse events with 94% being reported as non-serious, and 6% classified as serious.

Local reactions were the most common. “These are rare events,” the speaker said of anaphylaxis.

After a short break in the meeting, executives from Janssen spoke of their vaccine’s data including its efficacy globally and that it was effective in the US, Brazil, and South Africa against the emerging variants.

The company expects to be able to ship 100 million doses to the US within the first half of 2021. They also reported no safety signals in terms of AESIs, and their platform has been used for Ebola vaccines.

More updates to come.

Update, 10:22am:

After the introductions of the members of the VRBPAC, a review was given of the number of COVID-19 cases, the number of deaths thus far, and the EUAs of the Pfizer-BioNTech and Moderna vaccines. This led to the introduction of the Janssen COVID-19 vaccine and its application.

A discussion on the COVID-19 variants that were first identified in the United Kingdom, South Africa, and Brazil was provided. This included a review of the latest information including a Brazilian outbreak which led to a second spike in cases, and a decrease in cases in the United States.

A discussion of genomic surveillance and epidemiology touched upon novel variant detection. Currently we are sequencing only a small proportion of variants and only 5% to 10% of specimens are sampled.

A breakdown of the current variants (United Kingdom, South Africa, and Brazil) demonstrated the largest number of cases in the US being the UK variant and the lowest being the Brazilian variant with just a handful of cases. However, it was acknowledged that these variants were likely much more widespread, and could exist throughout the US.

More updates to come.

Today's Meeting

Update, 8:00am:

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss the efficacy data of Janssen’s Ad26.COV2.S COVID-19 vaccine.

As this committee did in the previous meetings for the Pfizer-BioNTech and Moderna vaccines, today’s meeting will be discussing the data presented by Janssen, which is a subsidiary of Johnson & Johnson.

By the end of today’s meeting, the committee will vote on whether to recommend an EUA for the vaccine.

What makes Janssen’s application different from the previous 2 vaccines, is that it is for a single dose vaccine. It is currently the only vaccine looking at a one-shot administration for prevention of COVID-19.

If the vaccine is recommended today, this will be a significant step towards granting an EUA to Janssen, as the FDA strongly weighs the recommendations of the VRBPAC.

Contagion® will be following the meeting and reporting news from it, so check back frequently and refresh this page throughout the day to get ongoing updates.

Earlier this week, Janssen reported data from its phase 3 trial supporting its FDA application. The company’s vaccine showed the one-shot adenovirus prophylaxis provided 66.1% efficacy (95% CI, 55.0 – 74.8) in preventing COVID-19 versus placebo ≥28 days after administration.

The vaccine uses a replication-incompetent recombinant adenovirus type 26 (Ad26) vector which encodes a full-length and stabilized SARS-CoV-2 spike (S) protein.The vaccine is built upon the company’s AdVac platform, which was used for its Ebola vaccine, and is also being used for investigative prevention of Zika virus, filovirus, HIV, HPV, malaria, and respiratory syncytial virus (RSV) in other vaccine forms.