J&J Vaccine Authorized & Rolling Out

• In today’s Recommendations for Industry, we discuss FDA’s issuance of an EUA for the J&J Janssen COVID-19 Vaccine for those 18 years of age and older. Read more below.
• The Johnson and Johnson’s EUA has been approved by the FDA and recommended by the CDC. Last week, we discussed the J&J vaccine. Check it out here!
• The head of the CDC warns that we must be vigliant of the COVID-19 variant B117. A few weeks ago, B117 cases only accounted for 1 – 4% of all COVID cases. Now, the B117 variant accounts for 10% of all COVID-19 cases.
• A recent survey of the U.S. population finds 55% of adults have either received one dose or will get it as soon as they can. This is a ~20% increase since December!
• COVID Act Now reports that CNN discusses evidence of a new variant (B.1.526) spreading in New York City. This variant may be more effective at evading immune responses; it contains two mutations (one found in the B.1.351 variant first identified in South Africa and another found in the P.1 variant first identified in Brazil).  
• Moderna is ready to test its new vaccine version designed to be more effective against some newer varaints.
• COVID testing in the U.S. has fallen by 30% in recent weeks. Some places are testing half as many people as in November and other sites are only testing at 35% of capacity. Some reasons for the COVID testing decreases can be attributed to potentially fewer exposures, less travel, bad weather leading to closed sites, increased vaccine rollout, pandemic fatigue, but also a decrease in infections and spread.
• Thousands of farmworkers in the United States, who ensure the functionality and supply of our food system, are being prioritized for COVID-19 vaccination!
• The New York Times reports that “Every coronavirus variant of concern to researchers around the world has been circulating in Houston [Texas] at a low level for at least six to eight weeks, a new study has found. Houston is the first U.S. city to find all of the variants, including those recently reported in California and New York and the ones found in Brazil, Britain and South Africa”.
• Canada to receive 6.5 million Covid-19 vaccines by end of March

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 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 20^th, 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.