The vaccine is the third to be considered for the US market, and it is the first single-dose Covid-19 shot available here. Like the earlier Covid-19 vaccines, it was developed and tested at a remarkable rate, which summed up in months what would last years before the pandemic.
But there are few answers as to what will happen if and when it is approved. The White House said Monday it has not yet made any plans to distribute the vaccine if it gets authorization. There are vague totals as to how many doses are available immediately, and no word on exactly where the doses will go.
However, clinical trial investigators are confident that the Johnson & Johnson vaccine will be granted promptly, as with the Pfizer / BioNTech and Moderna Covid-19 vaccines.
“We certainly hope that it will be so fast, if not faster,” said dr. Pat Flynn of the St. Jude Children’s Research Hospital in Memphis, one of the principal investigators of the J&J trial, said.
“I would expect it to be approved, and we definitely need it,” Carson said.
Carson said he is eager to see more information about the vaccine; according to the agency, details on what was submitted to the FDA should be available no later than Wednesday.
How the vaccines differ
On Friday, the FDA committee will look at possible safety issues. With the Moderna and Pfizer vaccines, for example, the committee asked questions about a handful of cases of severe allergic reactions to those vaccines. Severe side effects were extremely rare.
Its effectiveness against moderate and severe diseases varies from country to country: 72% in the USA, 66% in Latin America and 57% in South Africa. It was measured from a month after the shot.
The differences in regional efficiency may be due in part to the number of variants in circulation, experts said.
In the South African part of the clinical trial, the majority of cases were due to a variant known as B.1.351, which is more transmissible and contains mutations that make it less susceptible to the immune response against the antibody – including antibodies. by vaccination.
While the Pfizer vaccine shows 95% efficacy to prevent a symptomatic Covid infection after receiving two doses and the Modern vaccine was 94.1% effective, scientists said it is not fair to compare vaccines not, as they have not been tested against each other.
The Pfizer and Moderna vaccines, with this almost identical efficacy, were tested at about the same time. The J&J vaccine was tested a few months later when there were more variants in circulation.
“I think in the end we do not know if one is better than the other,” Carson said.
Dr. Aditya Guar, one of the investigators with the St. Jude-arm of the trial, said people should understand that the J&J vaccine is doing its job very well.
“It is the result of the prevention of hospitalization and death that is important, and for that it is complete,” Guar said. “It’s effective with a single dose of vaccine and it works.”
Carson said patients and friends asked him if they should take the J&J vaccine if it was available.
All vaccine manufacturers are investigating whether a booster dose can provide better protection against coronavirus variants. J&J also has an ongoing late trial testing a two-dose vaccination program; the company is expected to achieve results in the second half of 2021.
What happens next
Johnson & Johnson says they are confident about its candidate for single-vaccine vaccine.
“The company’s EUA submission is based on the efficacy and safety data of the Phase 3 ENSEMBLE clinical trial, which demonstrates that the single-dose investigative vaccine meets all primary and significant secondary endpoints,” a spokesman for J&J said in an email to CNN. “A single-dose vaccine is considered by the World Health Organization to be the best option in pandemic conditions, which improves access, distribution and compliance.”
If the committee recommends an authorization for the use of the J&J vaccine, the FDA will then decide whether to accept the recommendation. It usually does, and it can decide almost immediately, as with the Pfizer and Moderna vaccines.
For Pfizer, the process took just over three weeks. For Moderna, it was a little over two.
Vaccinations can begin shortly thereafter. The Johnson & Johnson vaccine is expected to spread more easily and requires only one shot.
Press for more doses
There are still questions about how many doses are available. The company will not be asked to address the specific production numbers directly from week to week. The U.S. government has ordered 100 million doses to be delivered by June, and J&J told CNN it could comply with the commitment.
“The production of our vaccine is a very complex process that requires very special capabilities and experiences,” according to the prepared remarks of Johnson & Johnson’s Nettles. “As a result, there are major challenges associated with the scale of production production and the acceleration of the timeline required for a COVID-19 vaccine.”
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said Monday that more doses are coming down the road.
“There will not be many doses on the heels of the EUA, but it will accelerate as we move towards the contractual arrangement in the months to come when 100 million doses will be given,” Fauci said.
It is also not clear who is able to fit in for the vaccine. Andy Slavitt, a senior adviser to the White House Coronavirus Response Team, said Monday that the federal government will await an FDA decision and the guidance of the CDC committee.
Fauci said the FDA can find information in the trial data that suggests the best strategies for its distribution.
“In the data, there may be tips on how it will be used most appropriately and effectively. If we find out, the distribution policy will be much more scientifically based,” Fauci said.