What to Know Earlier than Voting on the Prime FDA Panel
Vials of Johnson & Johnson’s Janssen Coronavirus Disease (COVID-19) vaccine candidate are shown in an undated photo during the Phase 3 ENSEMBLE trial.
Johnson & Johnson | via Reuters
A key Food and Drug Administration advisory body is due to vote on Friday on whether to recommend Johnson & Johnson’s emergency approval of the Covid-19 vaccine to pave the way for a third preventive treatment to be distributed in the United States
A positive vote by the Advisory Committee on Vaccines and Related Biological Products will likely pave the way for the US agency to approve J & J’s emergency vaccine. The committee plays a pivotal role in getting vaccines approved in the U.S. and verifying that the shots are safe for public use. While the FDA does not need to follow the committee’s recommendation, it often does.
At a similar request from Pfizer and Moderna, the FDA approved these companies’ vaccinations the day after the committee of external medical advisors endorsed emergency use approval. If J&J follows the pattern, a third vaccine could be approved on Saturday.
According to data from Johns Hopkins University, the US will need a range of drugs and vaccines to end the pandemic that has infected more than 28.3 million Americans and killed at least 505,899 people as of Thursday. Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J&J only requires one dose, which makes logistics easier for healthcare providers. J & J’s vaccine, unlike the other two vaccines, can also be stored at refrigerator temperature for months.
Here’s what you can expect:
1. When do you vote?
The meeting is expected to take place from 9:00 a.m. to 5:30 p.m.
Prior to voting, medical experts will evaluate J & J’s clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks of being approved for emergency use. The company is asking the FDA to approve use of the vaccine in people 18 years and older. Pfizer’s has been approved for use in people aged 16 and over. The poor data in younger teenagers was a sticking point for the few advisory board members who voted against approval of the Pfizer BioNTech vaccine in December.
2. What happens next?
The FDA will decide if J&J should clear the vaccine for emergency use. In the Pfizer and Moderna cases, the agency’s final decision came one day after the meeting.
Such approval by the FDA is not synonymous with full approval, which can usually take months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval
3. When will I get the vaccine?
Initially, the doses would be limited. Jeff Zients, President Joe Biden’s Covid Tsar, told reporters Wednesday that the federal government expects to ship 3 to 4 million doses of J & J’s vaccine to states, pharmacies and community health centers next week pending FDA approval .
The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told House lawmakers on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. Zients said the federal government will “do everything we can” to get production going.
4. Should I have the vaccine?
J & J’s vaccine provides 66% overall protection against Covid-19, compared to about 95% for Pfizer and Moderna’s vaccine. Some people have wondered if they should get the J&J vaccine because of the lower rate of effectiveness.
However, infectious disease experts point out that J & J’s results cannot be directly compared to the other two vaccines because it is a single dose and the company’s study was conducted when more infections emerged as well as new, more contagious variants .
The Chief Medical Officer of the White House, Dr. Anthony Fauci said Americans should take every approved vaccine they can get. He also notes that J & J’s vaccine prevented 100% of virus-related hospitalizations and late-stage deaths.
“The most important thing, more important than preventing someone from getting a pain and a sore throat, is preventing people from getting serious illness,” he told reporters on a January 29 call and human suffering and death in this epidemic. “
5. What are the side effects?
Analysis by age, race and comorbidity did not reveal any specific safety concerns about the vaccine, according to an FDA report released on Wednesday.
Headache, fatigue, and muscle pain were some of the most common side effects in people who received the vaccination, the report said. There have also been reports of nausea, fever, and pain at the injection site. According to the report, there have been no reports of anaphylaxis, a serious and life-threatening allergic reaction.
The report identified a few cases of Bell’s Palsy where half of your face fell down but were “balanced” with the number generally noted in the general population. The FDA previously announced that the condition would be monitored among vaccine recipients after flagging it as a potential problem with Pfizer’s shots, and noted that this isn’t necessarily a side effect, but it is worth looking out for .
Medical experts say vaccine side effects are common and actually indicate that the shots are working as intended. The CDC recommends talking to a doctor about taking over-the-counter drugs if you experience pain or discomfort after the shot.
– CNBC’s Noah Higgins-Dunn contributed to this report.