Johnson & Johnson Covid-19 vaccine: FDA committee should consider authorization for single dose injection this week

The vaccine is the third in consideration for the United States market and would be the first Covid-19 single dose vaccine available here. Like previous Covid-19 vaccines, it was developed and tested at a remarkable pace, condensing into months what could have taken years before the pandemic.

But there are few answers as to what will happen if and when authorized. The White House said on Monday that it has not yet made plans to distribute the vaccine if it gains authorization. There are total vagueness of how many doses will be available immediately and no word on where exactly those doses will go.

The Biden government said last week that if authorized, there are likely to be millions of single-digit doses available in the coming weeks. On Tuesday, Dr. Richard Nettles of Johnson & Johnson will say that the plan “is to start shipping immediately after emergency use authorization and deliver enough single doses by the end of March to allow vaccination of more than 20 million Americans, “according to observations prepared to be delivered to a subcommittee of the Chamber’s Energy and Commerce Committee.

Still, clinical trial researchers are confident that the Johnson & Johnson vaccine will be authorized quickly, as was the case with the Pfizer / BioNTech and Moderna Covid-19 vaccines.

“We hope it will be just as fast, if not faster,” said Dr. Pat Flynn of St. Jude Children’s Research Hospital in Memphis, a leading investigator in the J&J study.

Johnson & Johnson officially applied to the FDA for emergency use on February 4. Adding a third vaccine to the mix – particularly a vaccine that needs only one dose – would add both supply and flexibility to the United States’ vaccination efforts.
Biden's team finds it difficult to make promises - let alone keep it
“It seemed to work very well in preventing the most severe form of the disease,” said Dr. Jeff Carson, who co-led the study at Rutgers Biomedical and Health Sciences. Its test arm, the second largest at J&J, had more than 800 volunteers. “They didn’t show us any data about the company’s side effect, but I think it’s not a big problem.”

“I expected it to be approved and we certainly need it,” said Carson.

Carson said he is looking forward to seeing more data about the vaccine; details of what has been submitted to the FDA should be available online by Wednesday, according to the agency.

How vaccines differ

On Friday, the FDA committee will examine any possible security issues. With the Moderna and Pfizer vaccines, for example, the committee asked questions about a handful of cases of severe allergic reaction to these vaccines. Serious adverse reactions were extremely rare.

The committee will also review the vaccine’s effectiveness. According to the Johnson & Johnson interim results, the data showed that the vaccine was 66% effective in preventing moderate and severe illnesses. The vaccine is 85% effective in general in preventing hospitalization and 100% in preventing death in all regions where it was tested.
Is it time to postpone the second dose of coronavirus vaccines?

Its effectiveness against moderate and severe illnesses varied 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 the injection.

Differences in regional effectiveness may be partly due to the number of variants in circulation, experts said.

In the South African arm of the clinical trial, most 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 antibody response – including antibodies that would be induced by vaccination.

While the Pfizer vaccine showed 95% effectiveness in preventing a symptomatic Covid infection after a person received two doses and the Modern vaccine was 94.1% effective, the scientist said it is not fair to compare vaccines, since they have not been tested against each other.

The Pfizer and Moderna vaccines, with this almost identical effectiveness, were tested at almost the same time. The J&J vaccine was tested a few months later, when more variants were circulating.

“I think, in the end, we don’t know if one is better than the other,” said Carson.

Vaccines - despite the variants - are still good news

Dr. Aditya Guar, one of the researchers in the study’s St. Jude arm, 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 complete,” said Guar. “It is effective with a dose of the vaccine and it works”.

Carson said patients and friends have asked him if they should get the J&J vaccine when it becomes available.

“My advice to all my patients and all my friends is to get the first vaccine you can. That’s what matters most, to be protected,” said Carson.

All vaccine manufacturers are investigating whether a booster dose could provide better protection against coronavirus variants. J&J also has an ongoing study in the final stage to test a two-dose vaccination program; The expectation is that the company will have these results in the second half of 2021.

What happens next

Johnson & Johnson says it is confident about its single-dose candidate vaccine.

The first Biden-era vaccine against Covid-19 is hitting the market, but new bumps could hinder the big launch

“The company’s presentation in the US is based on first-line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the experimental single-dose vaccine met all important primary and secondary endpoints,” said a spokesman. of J&J by email to CNN. “A single dose vaccine is considered by the World Health Organization to be the best option in pandemic settings, improving access, distribution and compliance”.

If the committee recommends an emergency use authorization for the J&J vaccine, the FDA will decide next whether to accept that recommendation. It usually works, and you can make your decision almost immediately, as you did with the Pfizer and Moderna vaccines.

Then, the US Disease Control and Prevention Center’s Immunization Practices Advisory Committee will meet to discuss whether the vaccine should be given to Americans and, if applicable, this committee helps to prioritize who should receive the vaccine first. . The committee has an emergency meeting scheduled for February 28 and March 1.
Vaccines for all Americans by July?  What to know about Covid-19 on Wednesday

For Pfizer, the process took just over three weeks. For Moderna, it was just over two.

Vaccination can begin soon afterwards. The Johnson & Johnson vaccine is expected to be easier to distribute and would require only one injection.

“If you think about it on a population basis, the J&J vaccine may offer more protection,” said Dr. Philip Grant, principal investigator for the J&J trial at Stanford University Medical Center. “You know that if you give 10 injections of the J&J vaccine, that is protection for 10 people. Ten injections of Pfizer or Moderna protect five people. You know, even in the short term, it will have a big role in the United States.”

Push for more doses

After a week of distribution, pharmacies have a family order: 'We just need more vaccines'

Still, doubts remain about how many doses will be available. When questioned, the company did not directly address specific weekly production numbers. The US government has ordered 100 million doses to be delivered by June and J&J told CNN that it can fulfill that commitment.

The company has struggled to increase production, and the Biden administration has maintained control over manufacturing, saying it is doing “everything we can” to speed up the delivery schedule.

“The production of our vaccine is a highly complex process that requires very special skills and experience”, according to the observations prepared by Johnson & Johnson’s Nettles. “As a result, there are significant challenges inherent in scaling manufacturing production and accelerating the schedule required for a COVID-19 vaccine.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the White House, said on Monday that more doses will come in the future.

“There will not be many doses right after the United States, but that will accelerate as we enter the months when we reach the contractual agreement on when 100 million doses will be given,” said Fauci.

It is also unclear who may be in line for the vaccine. Andy Slavitt, a senior adviser on the White House coronavirus response team, said on Monday that the federal government will await an FDA decision and guidance from the CDC committee.

Fauci said the FDA can find information in the trial data that suggests the best strategies for distributing it.

“In the data, there may be clues as to how it would be used in the most appropriate and effective way. When we discover this, the distribution policy would become much more scientifically substantiated,” said Fauci.

.Source