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The vaccine is the third under study for the US market, and is believed to be the first single-dose Covid-19 vaccine available here. Like previous Covid-19 vaccines, it has been developed and tested at a remarkable rate, condensing into months what could have taken years before the pandemic.
But there are few answers on what will happen if and when it is allowed. The White House said on Monday that it had yet to plan to distribute the vaccine if it got clearance. There are vague totals on the number of doses available immediately and no word on where exactly those doses are going.
Nonetheless, clinical trial researchers are confident that the Johnson & Johnson vaccine will be cleared quickly, as happened with the Pfizer / BioNTech and Moderna Covid-19 vaccines.
“We hope it will be as quick, if not faster,” said Dr Pat Flynn of St. Jude Children’s Research Hospital in Memphis, one of the lead investigators of the J&J trial.
“I think it will be approved, and we definitely need it,” Carson said.
Carson said he was eager to see more data on the vaccine; details on what was submitted to the FDA should be available online no later than Wednesday, according to the agency.
How vaccines differ
On Friday, the FDA committee will review possible safety concerns. With the Moderna and Pfizer vaccines, for example, the committee asked about a handful of cases of severe allergic reactions to these vaccines. Serious side effects were extremely rare.
Its effectiveness against moderate and severe illness varies from country to country: 72% in the United States, 66% in Latin America and 57% in South Africa. This was measured from one month after firing.
The regional efficiency differences may be partly due to the number of variants in circulation, the experts said.
In the South African arm of the clinical trial, the majority of cases were due to a variant known as B.1.351, which is more transmissible and carries mutations that make it less susceptible to the immune response of antibodies – including antibodies that would be caused by the vaccination.
While the Pfizer vaccine was shown to be 95% effective in preventing symptomatic Covid infection after a person received two doses and the Moderna vaccine was 94.1% effective, the scientist said he did not was not fair to compare the vaccines because they had not been tested against each other.
The Pfizer and Moderna vaccines, with this almost identical efficacy, were tested at around the same time. The J&J vaccine was tested a few months later, as other variants circulated.
“I think at the end of the day we don’t know if one is better than the other,” Carson said.
Dr Aditya Guar, one of the investigators in the St. Jude part of the trial, said people need to understand that the J&J vaccine does its job very well.
“It is the result of preventing hospitalization and death that is important, and for that, it is comprehensive,” Guar said. “It’s effective with just one dose of the vaccine and it works.”
Carson said patients and friends have asked him if they should take the J&J vaccine when it becomes available.
All vaccine makers are investigating whether a booster dose might offer better protection against the coronavirus variants. J&J also has an ongoing late phase trial to test a two-dose vaccination program; The company is expected to achieve these results in the second half of 2021.
What happens next
Johnson & Johnson say they are confident about their single dose vaccine candidate.
“The company’s EUA submission is based on leading efficacy and safety data from the ENSEMBLE phase 3 clinical trial, demonstrating that the investigational single-dose vaccine met all endpoints primary and key secondary, “a J&J spokesperson said in an email to CNN. “A single dose vaccine is considered by the World Health Organization as the best option in pandemic situations, improving access, distribution and adherence.”
If the committee recommends an emergency use authorization for the J&J vaccine, the FDA will then decide whether it wishes to accept that recommendation. He usually does, and he could make his decision almost immediately, as he did with the Pfizer and Moderna vaccines.
For Pfizer, the process took a little over three weeks. For Moderna, it was a little more than two.
Vaccinations could start soon after. Johnson & Johnson’s vaccine is expected to be easier to distribute and would only require one vaccine.
Push for more doses
However, questions remain about the number of doses available. When asked, the company would not directly address specific weekly production numbers. The U.S. government has ordered 100 million doses delivered by June and J&J told CNN it can meet that pledge.
“The production of our vaccine is a very complex process that requires very special skills and experience,” according to remarks prepared by Johnson & Johnson’s Nettles. “As a result, there are significant challenges inherent in scaling up manufacturing production and speeding up the schedule needed 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 on Monday that more doses would come.
“There won’t be a lot of doses right after the EUA, but that will accelerate as we move into the months towards the contractual arrangement where 100 million doses will be administered,” Fauci said.
It’s also unclear who might be in line for the vaccine. Andy Slavitt, senior advisor to the White House Coronavirus Response Team, said on Monday that the federal government would await a decision from the FDA and advice from the CDC committee.
Fauci said the FDA could find information in the trial data that would suggest the best strategies for distributing it.
“In the data, there may be clues as to how this would be used in the most appropriate and efficient way. When we find out, then the distribution policy would become much more scientifically sound,” Fauci said.
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