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J&J Vaccine Authorized & Rolling Out

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J&J Vaccine Authorized & Rolling Out

Key Points:

Recommendations for Industry

J&J Vaccine Authorized & Rolling Out

On Saturday, February 27, FDA  issued an emergency use authorization (EUA) for the J&J Janssen COVID-19 Vaccine for those 18 years of age and older. Having received a nod of approval for the vaccine on Wednesday, J&J began readying distribution with an initial roll-out of 3.9 million doses.   

On Friday, TAG provided an overview of the most significant differences between the J&J vaccine with those from Pfizer and Moderna, including that it is a single-shot vaccine with generally fewer and less severe side effects, and no instances of anaphylaxis. And it can be kept at refrigeration temperatures.

With three vaccines now available in the U.S. (as well as in Canada, with it’s third being AstraZeneca rather than J&J), TAG is getting the question: Should I prefer one vaccine over another? TAG’s answer is no. We recommend that you take whatever vaccine is made available to you and your workforce as soon as it is available.

While the J&J vaccine is shown as having a lower general efficacy than Pfizer and Moderna, it has high efficacy of 85% where it counts – against severe illness. So all three offer significant reduction in hospitalizations and mortality.

With just over 75 million vaccine doses administered in the U.S., about 25 million people (7.6%) are fully vaccinated. As a single-dose vaccine, we see the J&J vaccine as helping to significantly increase this number even more rapidly.

In Case You Missed It

  • In Friday’s Recommendations for Industry, we discuss the J&J vaccine being reviewed for EUA by FDA today. [Read More]
  • 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.
  • In Wednesday’s Recommendations for Industry, we discuss post-vaccine symptomatic return to work for those receiving the vaccine and not feeling well. In addition, we discuss the US Risk Matrix. [Read More]
  • Do we still need to wear masks in the office with cases dropping? We recently discussed the continued need for mask-wearing in offices.

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