Vials of Johnson & Johnson’s Janssen coronavirus disease vaccine candidate (COVID-19) are seen during the Phase 3 ENSEMBLE trial in an undated photograph.
Johnson & Johnson | via Reuters
A key advisory panel from the Food and Drug Administration is scheduled to vote on Friday on the recommendation for Johnson & Johnson’s Covid-19 vaccine approval for emergency use, which would help pave the way for distributing a third preventive treatment in the United States. USA
A favorable vote by the Vaccine and Related Biological Products Advisory Committee is likely to pave the way for the U.S. agency to approve the J&J vaccine for emergency use. The committee plays a central role in the approval of vaccines in the United States, checking whether the vaccines are safe for public use. Although the FDA does not have to follow the committee’s recommendations, it usually does.
During similar requests by Pfizer and Moderna, the FDA authorized the vaccination of these companies the day after the committee of external medical consultants supported the emergency use authorization. If J&J follow the pattern, a third vaccine may be authorized on Saturday.
Public health officials say the United States will need a series of drugs and vaccines to end the pandemic, which infected more than 28.3 million Americans and killed at least 505,899 by Thursday, according to data compiled by Johns Hopkins University. Unlike Pfizer and Moderna vaccines, which require two doses administered three to four weeks apart, J&J requires only one dose, facilitating logistics for healthcare professionals. The J&J vaccine can also be stored at refrigerator temperature for months, unlike the other two vaccines.
Here’s what to expect:
1. When will they vote?
The meeting is provisionally scheduled to take place from 9:00 am to 5:30 pm ET.
Before the vote, medical experts will evaluate data from J&J clinical trials and offer their opinions on the vaccine, including whether the benefits outweigh the risks of an emergency use authorization. The company is asking the FDA to approve the use of the vaccine in people aged 18 and over. Pfizer has been released for use by people at least 16 years of age. The sparse data in younger adolescents was an obstacle for the few members of the advisory committee who voted against the authorization of the Pfizer-BioNTech vaccine in December.
2. What happens next?
The FDA will make the decision to release the J&J vaccine for emergency use. In the Pfizer and Moderna cases, the agency’s final decision came a day after the meeting.
This FDA authorization is not the same as full approval, which can usually take months longer. J&J, like Pfizer and Moderna, submitted only two months of safety data, but the agency usually requires six months for full approval
3. When will I receive the vaccine?
Initially, doses would be limited. Jeff Zients, President Joe Biden’s Covid czar, told reporters on Wednesday that the federal government expects to send 3 to 4 million doses of the J&J vaccine next week to states, pharmacies and community health centers, while awaits FDA authorization.
The company expects to deliver 20 million doses by the end of March, Dr. Richard Nettles, vice president of medical affairs for the United States, Dr. Richard Nettles, told House legislators on Tuesday. J&J has an agreement with the U.S. government to supply 100 million doses of its vaccine by the end of June, and Zients said the federal government will do “everything we can” with the company to increase production.
4. Should I get the vaccine?
The J&J vaccine is 66% effective overall in protecting against Covid-19 compared to about 95% for the Pfizer and Moderna vaccine. Some people questioned whether they should receive the J&J vaccine due to the lower rate of effectiveness.
But infectious disease experts point out that J&J’s results cannot be compared directly with the other two vaccines because it is a single dose and the company’s test was carried out when there were more infections, as well as new, more contagious variants.
The White House Chief Medical Adviser, Dr. Anthony Fauci, said Americans should get any authorized vaccine they could get. He also notes that the J&J vaccine prevented 100% of hospitalizations and deaths related to the virus in its final stage test.
“The most important thing, more important than preventing someone from having pain and a sore throat, is to prevent people” from contracting serious illnesses, he told reporters on a January 29 call. “This will greatly relieve stress and human suffering and death in this epidemic.”
5. What are the side effects?
No specific safety concerns for the vaccine were identified when analyzed for age, race and comorbidities, according to an FDA report published Wednesday.
Headaches, fatigue and muscle aches were some of the most common side effects among people who received the inoculation, the report said. There have also been reports of nausea, fever and pain at the injection site. There were no reports of anaphylaxis, a serious and life-threatening allergic reaction, according to the report.
The report found some cases of Bell’s palsy, a condition that causes half of his face to fall, but they were “balanced” with the number generally found in the general population. The FDA had previously said that the condition would be monitored among vaccine recipients after being flagged as a potential concern with Pfizer vaccines, noting that it is not necessarily a side effect, but it is worth watching.
Medical experts say the side effects of vaccines are common and, in fact, indicate that the injections are working as expected. The CDC recommends talking to a doctor about taking over-the-counter medications if you feel pain or discomfort after receiving the injection.
—Noah Higgins-Dunn of CNBC contributed to this report.