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March 1, 2021
Emergency Use Authorization (EUA) was given to Johnson & Johnson’s COVID-19 vaccine this weekend, giving United States’ citizens a third option for a vaccination.
The Associated Press reported that J&J will be shipping vaccine on Sunday night. The vaccine has been approved under EUA for adults 18 years and older. J&J says it plans to deliver about 16 million doses by the end of March and 100 million by the end of June.
The Food and Drug Administration hosted its Vaccine and Related Biological Products Advisory Committee Meeting Friday to deliver along with the CDC updates on the Pfizer and Moderna COVID-19 vaccines along with sharing data about the J&J vaccine clinical trials.
The independent committee of advisors and experts in the vaccines and/or infectious disease fields gives recommendations the FDA takes into consideration before approving vaccines for emergency use authorization rather than full FDA approval during the pandemic.
Representatives from CDC gave an update on the safety of the two currently available vaccines under EUA. The J&J team presented their data, followed by an open forum with the public before the FDA’s presentation and Q&A.
The Apex team watched the online streamed hearings. Here are some items we noted during the day about the J&J vaccine.
The vaccine is called Ad26.COV2.S, and it works differently than others
The J&J vaccine is an adenovirus viral vector vaccine. This is a different mechanism of action from the Pfizer and Moderna vaccines.
- J&J took a harmless adenovirus (the viral vector) and then replaced its own genetic instructions with the spike protein genes from the coronavirus.
- This adenovirus viral vector technology has been around since the 1960s and has been used in other vaccines.
J&J’s vaccine is a one-shot dose (so far)
Whereas the Pfizer and Moderna vaccines both require two doses, the J&J vaccine was studied and presented today as only a one-shot dose. However, there are two-dose studies outside the US currently underway.
- The large-scale Phase 3 clinical trial — called ENSEMBLE — enrolled approximately 44,000 patients ages 18 to 59, then 60+.
- The primary goal of the study was to prevent moderate to severe/critical COVID-19 cases confirmed by central lab at least 14 days and 28 days after vaccination.
- One vaccine dose is 0.5 mL, and there will be five doses per vial with no dilution required and given by needled into the muscle.
- The vaccine can be stored for three months between 36 to 46 degrees Fahrenheit. It has a shelf life of up to two years when frozen.
- Unlike the original Pfizer and Moderna vaccines, the J&J vaccine does not require freezers for storage. The FDA provided an update last week saying the Pfizer vaccine could have alternate means of storage.
The vaccine candidate was 72% effective in the US and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination
- The vaccine is also 85% effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death after Day 28.
- There was some discussion on J&J’s lack of “mild” to “moderate” definitions of COVID-19 data in the Phase 3 US trial.
The side effects were similar to other COVID-19 vaccines
The side effects were mild to moderate, and happened less frequently, in adults greater than 60 years old compared to those 18 to 50 years of age.
- The clinical trials showed common side effects such as pain, redness, swelling, fatigue, headache, muscle pain, nausea and fever within seven days after vaccination.
- Interestingly, a quarter of trial participants took fever-reducing drugs like acetaminophen or ibuprofen, and committee members discussed using these drugs may decrease efficacy of the vaccine.
- There was one post-study severe adverse event of a severe allergic reaction reported in a current ongoing clinical trial outside of the Phase 3 US clinical trial.
- There were eight patients who were pregnant, even though participants were screened and excluded if pregnant or planning a pregnancy within three months of vaccination. Four received the vaccine, while four received the placebo.
- Of the four pregnant patients that were given the vaccine, there was one spontaneous abortion, one ectopic pregnancy and the other two are being further monitored. J&J plans a pregnancy study later.
Could this be a game changer? If so, why?
Due to the vaccine achieving high efficacy in one dose against COVID-19 and requires no freezing, it could be a gamechanger for employers, because this vaccine could potentially be given in workplace settings.
- Of course, the state of Indiana requires registration for COVID-19 vaccination sites, and it has yet to be determined to be granted emergency use authorization.
Apex will continue to monitor updates with the J&J vaccine.