Last week, the director of the National Institute of Allergy and Infectious Diseases, dr. Anthony Fauci, said Johnson & Johnson ‘just around the corner’ authorizes the U.S. Food and Drug Administration to get emergency approval for its Covid-19 vaccine.
It could still take weeks for the vaccine to be approved by the US Food and Drug Administration, and it is not yet clear when any of the key steps will be taken.
The two vaccinations already available in the United States are very effective, but all eyes are on Johnson & Johnson’s, which are only a single dose and which can be administered much more easily.
“If this vaccine proves to be safe and effective, it could have major consequences for the deployment of the vaccine because J&J is committed to producing and using at least one billion doses of vaccine during this calendar year, including at least 100 million doses for the American population., “says dr. Dan Barouch of Harvard Medical School, who helped develop Johnson & Johnson’s vaccine candidate.
“If it’s a single-dose vaccine, then a billion vaccine doses can be translated into a billion people being vaccinated,” Barouch said on CNN’s Coronavirus Fact vs Fiction podcast on Monday.
Waiting for trial results
J&J Phase 3 trial involves 40,000 volunteers; the company has reduced its trial by 60,000 due to the surge in Covid-19 cases across the country.
As with the other Covid-19 vaccine trials, the aim is to see how well the vaccine protects participants. The company recruits from different demographic groups and people with different health statuses. Researchers give half of the group the vaccine and half of the group a placebo, which does nothing, and then monitor who gets sick and whether safety issues arise.
“A single dose has major logistical implications,” said Michael Haydock, senior director of Informa Pharma Intelligence. “As far as the roll-out is concerned, it can really speed things up and simplify things a lot.”
The US ordered 100 million doses and the company manufactured them while testing the vaccine. Companies usually wait to make the vaccine after it has been approved, but which changed during the pandemic.
“The big question, of course, is, will it work?” Haydock said.
Steps to authorization
According to Paul Offit, director of the Vaccine Education Center at the Children’s Hospital in Philadelphia, and a member of the FDA’s vaccines and related, the process for the Johnson & Johnson vaccine should be the same as for the Moderna and Pfizer vaccines. Advisory Committee for Biological Products.
The change in leadership at the FDA and CDC should not make a difference in how long the process takes.
“I do not think it will change under the new administration at all,” Offit said.
If the data from the Phase 3 thesis shows that J & J’s Covid-19 vaccine works and is safe, then the company will apply to the FDA, which calls for an emergency use authorization (EUA).
While the FDA reviews the data, it plans to hold a public meeting of the Advisory Committee on Vaccines and Related Biological Products. The committee is made up of independent scientific and public health experts who will discuss the J&J data and make a recommendation to the agency.
Following the meeting, FDA staff members will consider the input of the committee, along with evaluating the agency’s data from the company, and will decide whether the vaccine should be authorized.
ACIP is a group of medical and public health experts who make recommendations on how the vaccine should be used in the population. The committee’s proposals become the guideline for determining which demographic groups should receive the vaccine.
Once the CDC committee has made a recommendation and it has been approved by the CDC director, vaccines can be sent and the weapons can go on.
CNN’s Amanda Sealy contributed to this report.