Last week, the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, said Johnson & Johnson is “very close” to seeking emergency use authorization for its Covid-19 vaccine from the Food and Drug Administration USA.
Still, it may take weeks for the vaccine to go through the US Food and Drug Administration authorization process and it is still unclear when any of these major steps will take place.
The two vaccines already available in the United States are highly effective, but all eyes are on Johnson & Johnson, which is a single dose and would be much easier to administer.
“If this vaccine proves to be safe and effective, it could have important implications for the launch of the vaccine because J&J has committed to producing and implanting at least one billion doses of vaccine during this calendar year, including at least 100 million doses for the vaccine. US population, “said Dr. Dan Barouch of Harvard Medical School, who helped develop the Johnson & Johnson vaccine candidate.
“If it is a single dose vaccine, then one billion doses of vaccine would translate into one billion vaccinated people,” Barouch said on Monday on CNN’s Coronavirus Fact vs Fiction podcast.
Waiting for test results
The J&J Phase 3 trial involves 40,000 volunteers; the company reduced the trial to 60,000 because of the increase in Covid-19 cases across the country.
As with other Covid-19 vaccine tests, the goal is to see how well the vaccine protects participants. The company recruits people from different demographic groups and people with different health conditions. The researchers give the vaccine to half the group and half a placebo, which does nothing, and then monitor who gets sick and whether safety problems arise.
“A single dose would have major logistical implications,” said Michael Haydock, senior director at Informa Pharma Intelligence. “In terms of implementation, it could really speed up and simplify things considerably.”
The United States has ordered 100 million doses and the company makes them while testing the vaccine. Typically, companies expect to make the vaccine after approval, but that changed during the pandemic.
“Sure, the big question is, will it work?” Haydock said.
Authorization steps
The process for the Johnson & Johnson vaccine should be the same as for the Moderna and Pfizer vaccines, according to Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA Vaccines and Related Committee Biological Products Advisory.
The change in leadership of the FDA and CDC should not make a difference in the length of the process.
“I don’t think that will change with the new administration,” said Offit.
If data from the Phase 3 trial shows that J&J’s Covid-19 vaccine works and is safe, the company will request what is known as the FDA’s emergency use authorization, or USA.
While the FDA analyzes the data, it schedules a public meeting of its Vaccine and Related Biological Products Advisory Committee. The committee is made up of independent scientists and public health experts who will discuss J&J data and make recommendations to the agency.
After the meeting, FDA team members consider the committee’s contribution along with the agency’s assessment of the company’s data and will make a decision on 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 suggestions become the guideline used to determine which demographic groups should receive the vaccine.
Once the CDC committee makes a recommendation and it is approved by the CDC director, vaccines can be sent and go to arms.
Amanda Sealy of CNN contributed to this report.