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J&J Vaccine Review (and authorization?) Coming Today
Acheson Group February 26, 2021 0 Comments

J&J Vaccine Review (and authorization?) Coming Today

Key Points:

  • In today’s Recommendations for Industry, we discuss the J&J vaccine being reviewed for EUA by FDA today. [Read More below]
  • The FDA is allowing for more flexible storage and transportation conditions for the Pfizer COVID-19 vaccine; undiluted frozen vials of the vaccine can be “transported and stored at conventional temperatures commonly found in pharmaceutical freezers […] for up to two weeks” as opposed to being in ultra-low temperature freezers.
  • The FDA has released new guidance for medical manufacturers related to addressing future SARS-CoV-2 variants that may emerge.
  • Queen Elizabeth is urging Britons to get a coronavirus vaccine; she discusses her experience with it, urging that people should “think about others rather than yourself.”
  • CIDRAP reports on two recent new studies that “detail [the] unique signs and symptoms in US children and teens with the rare but severe coronavirus-related multisystem inflammatory syndrome in children (MIS-C)” and how to distinguish these signs from severe COVID-19.
  • Based on current projections, the CDC estimates that by the end of the week of March 20th, there can be up to an additional 12,000 deaths; bringing the US death count to between 526,000 – 548,000.
  • In variant news:
    • There has been a newly detected COVID-19 variant identified in New York, known as the B.1.526 variant. It was first discovered in November 2020. Now, one in four (25%) of all viral sequences are being identified as B.1.526. 1.526 cases have been on the rise through February (increasing 12.3% in the past 2 weeks).
    • The B.1.427/B.1429 strains of COVID-19, first identified in California, now make up 50% of cases in at least 44 countries.
  • Despite its billion-dollar investment in COVAX, the S. is making it harder for the rest of the world to get COVID-19 vaccines.

Recommendations for Industry

J&J Vaccine Review (and authorization?) Coming Today

It is looking as though the U.S. will have a third COVID-19 vaccine soon. On Wednesday, an FDA staff report endorsed the Johnson & Johnson single-shot Janssen COVID-19 vaccine, so the agency’s Vaccines and Related Biological Products Advisory Committee is meeting today to review (and hopefully authorize) it for emergency use. If authorized, it will join the ranks of Pfizer and Moderna – with a few differences.

The most significant differences are that the J&J vaccine

  • Is a single-shot vaccine.
  • Has fewer and less severe side effects.
  • Has had no instances of anaphylaxis.
  • Can be kept at refrigeration temperatures – rather than the sub-zero temperatures required of the others.

Additionally, while both Pfizer and Moderna are mRNA vaccines, J&J uses adenovirus 26, a non-replicating human adenovirus type 26 (Ad26) vector, constructed to encode a stabilized form of the virus. J&J’s submitted vaccine data shows it to demonstrate 66% effectiveness overall, with higher efficacy of 72% in the U.S.

Having this third vaccine available has become critically beneficial, as we are beginning to see a flattening of case transmission – where we had previously been seeing a steady decline. Expecting that this is driven by the increased, rapid transmission rates of the new variants – including those first detected in California and New York, TAG continues to recommend that businesses retain all COVID-19 protections. Additionally, while we had expected that those who had been infected with COVID-19 (with symptoms or asymptomatically)  likely retained some immunity at least for a time, this may not be applicable to the variants, as South Africa did see some reinfection of the variant type in those who had had the original Wuhan-originating strain.

So, even as the vaccine becomes available for your workers – and a light flickers at the end of this long, arduous tunnel – continue to mask, social distance, sanitize, and avoid large gatherings.

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