Key Points:

• In today’s Recommendations for Industry, we discuss a few of the most common, recent questions – with answers. Read more below.
• As of today, in the U.S. anyone age 16 and older is eligible for vaccination!
• A recent Science article details the genomics and epidemiology of the P.1 variant first identified in Brazil. It finds that the P.1 variant first emerged mid-November 2020 and that it is 1.7 – 2.4-fold more transmissible than the original COVID-19 strain.
• Due to India’s fast-rising cases, Delhi has announced new lockdown measures.
• Australia and New Zealand have opened borders to one another and it is creating massive amounts of happiness!
• The White House discusses its upcoming $2B plan to enhance the tracking of COVID-19 variants. $1B will go to the CDC to monitor variant spread and conduct genomic sequencing to characterize the variants out there.
• As of today, more than half of all U.S. adults have received at least one dose of a COVID-19 vaccine. This is positive news; however, the difficult part comes now as vaccination resistance can pose larger issues that will prevent us from reaching herd immunity.

Vaccine Q&A – Youth Eligibility, Immunity Longevity, Full FDA Approval

TAG continues to receive questions related to the vaccines and becoming vaccinated. Following are a few of the most common, recent questions – with answers.

Q. Will vaccines become available for younger people? If so, when can we expect that?

A. On April 9, Pfizer requested amendments to the FDA EUA of its vaccine to “expand the use in adolescents 12 to 15 years of age,” based on data from its Phase 3 trial on youth of these ages, “which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine,” according to the Pfizer statement. The company also plans to request similar rulings by other regulatory authorities worldwide. From this, TAG would anticipate an announcement on this extended use sometime in May.

Q. We have heard that the vaccines are only good for six months; is this true?

A. Studies are showing that the vaccines provide immunity for at least six months; however, since the vaccines have only been given for that long, no data exists to show longer immunity. While there is not scientific data on the longer-term extent of immunity, TAG’s view is that immunity will likely last longer than the proven six months.

Q. While the Pfizer, Moderna, and Johnson & Johnson vaccines all achieved Emergency Use Authorization (EUA) earlier this year, when can we expect them to receive full approval?

A. Both Pfizer and Moderna having new data showing second-dose efficacy rates above 90%, both companies have indicated that they plan to file requests for full approval for their vaccines. As such, the vaccines could potentially be fully approved as soon as May, enabling the vaccines to be marketed and sold directly to individuals and private US companies. With the J&J vaccine paused for further review of rare blood-clotting cases (6 cases in 7 million doses given), we would expect any full approval of that vaccine to be further delayed.

• In Friday’s Recommendations for Industry, we discussed the efficacy of the COVID vaccines against the current variants. Read more here.
• The NYT has also put out an article on “Can the COVID Vaccine Protect Me Against Virus Variants?”
• In non-COVID news and essential in the public health realm, the WHO has released a report highlighting that there has been little progress in developing new and desperately needed antibiotics to fight against drug-resistant infections. See the WHO review here. See CIDRAP’s summary
• In a recent CVS Health discussion, the CEO of Pfizer has said that it might be likely a third dose of COVID-19 vaccinations will be needed within the next 6 – 12 months. He also echoes another aspect of what TAG has mentioned before; an annual COVID-vaccine will likely need to be received (just as with the flu vaccine).
• Many factors are influencing why young Brazilians are being hit harder by COVID-19.
• Aljazeera discusses why Canadian Atlantic provinces have been able to control COVID-19 more effectively than other areas of Canada – a lot related to “strong communication, collaboration, and cooperation between public health authorities”.
• In Wednesday’s Recommendations for Industry, we discussed this week’s risk matrix and how to answer your employees’ questions on the J&J vaccine. You can read more here.
• The Johnson & Johnson vaccine’s use in the U.S. is currently paused as there is investigation for blood clots.
• The NIH has begun its trial of anti-CD14 antibodies to treat COVID-19 respiratory disease. Read the news release here.