Enlarge /. A sign on the Johnson & Johnson campus on August 26, 2019 in Irvine, California.
After a one-day meeting on Friday, an advisory panel to the U.S. Food and Drug Administration voted 22-0 to recommend emergency clearance for Johnson & Johnson's one-of-a-kind, refrigerator-stable COVID-19 vaccine.
If the FDA accepts the panel's recommendation and grants the EEA – which it likely does – the country will have a third COVID-19 vaccine approved for use. Earlier this week, FDA scientists released their review of the vaccine and confirmed approval. Today's panel, the FDA's Vaccines and Related Biological Products Advisory Board (VRBPAC), continued to go through the data.
"It's a relatively easy call," said Eric Rubin, a Harvard researcher and voting member of the VRBPAC after the vote. "(The vaccine) is clearly going over the bar and it's nice to have a single-dose vaccine … the demand is so great (for vaccines) that it clearly has a place."
Authority observers expect the FDA to implement the decision quickly and possibly issue the EEA as early as February 27th. The FDA issued the EUAs for the two previously approved vaccines Moderna and Pfizer / BioNTech mRNA so quickly.
In addition, an advisory body to the Centers for Disease Control and Prevention, which is making recommendations on vaccine use, has scheduled an emergency meeting this Sunday to discuss vaccine use. This adds to speculation that the federal government will quickly approve and introduce the vaccine. If all the parts match, Johnson & Johnson's doses of COVID-19 vaccine could be delivered to vaccination sites early next week.
However, the rollout will not result in a large number of new cans immediately. It'll likely be a slow roll. In a congressional statement this week, a Johnson & Johnson executive said the company will provide 4 million doses under the EEA, of which a total of 20 million will be completed by the end of March and a total of 100 million by the end of June. Since the vaccine only requires a single shot, those 100 million doses equals 100 million people who are protected.
According to a detailed FDA review of data from Phase III clinical trials submitted by Johnson & Johnson, the vaccine was 66 percent effective in preventing moderate to severe COVID-19 28 days after vaccination. (Johnson & Johnson defined moderate cases as cases with two symptoms, such as cough and fever, which other studies would have classified simply as "symptomatic" infections.)
The international study, in which over 44,000 participants took part in different test locations, had different efficacies in different locations. In the US, the overall effectiveness was slightly higher at 72 percent. But in places where worrisome variants are widespread, the effectiveness declined. It was 64 percent effective in South Africa and 61 percent in Latin America.
Fortunately, the effectiveness against serious and critical diseases was consistently high in all test locations and age groups. The total effectiveness against serious illness was 85 percent 28 days after vaccination. By location, efficacy against serious diseases was 86 percent in the United States, 82 percent in South Africa and 88 percent in Brazil. In another analysis, there were no hospital admissions among vaccinated participants and 16 in the placebo group. As of February 5, there were seven COVID-19-related deaths in the study, all of which were in the placebo group.
Additionally, Johnson & Johnson is running a 30,000-person study to test whether adding a booster shot further increases its effectiveness.
In terms of side effects, the vaccine has a "favorable safety profile" according to the FDA. The most common side effects in the approximately 44,000 participants were injection site pain (49 percent), headache (39 percent), fatigue (38 percent) and myalgia (33 percent). There were 15 cases of bleeding conditions in vaccinated participants compared with 10 in the placebo group. There were also six cases of tinnitus (ringing in the ears) among the vaccinated and zero in the placebo group. It is unclear whether these conditions are related to the vaccine.
While anaphylaxis was a rare but documented event with the mRNA vaccines, it appears to be a lower risk with Johnson & Johnson's vaccine. There was a single case of a severe hypersensitivity reaction two days after vaccination that was considered likely to be vaccine-related. However, the reaction was not classified as anaphylaxis.