- Johnson & Johnson coronavirus vaccination generates a promising immune response.
- It is not yet clear whether the picture can inhibit COVID-19, or how it will compare to competing vaccines.
- The drug is expected to publish data within weeks which should provide more accurate information about the protection provided by the vaccine.
- Visit the Business Insider homepage for more stories.
Johnson & Johnson released updated early data about its COVID-19 vaccine on Wednesday, showing that it gave at least some immunity to participants in a clinical trial after a single dose.
The data, published in the New England Journal of Medicine, offer only suggestions on a tantalizing question: Could the vaccine, given as one picture, outperform the vaccines? already authorized by US regulators, which are given as two?
In the study, participants nested antibodies, measured in a unit called geometric mean titer, of 224 to 354, on day 29 after their first vaccine dose; these levels reached 288 to 488 by day 57. These levels may be sufficient to achieve immunity. But there was a major benefit in giving participants a higher dose. It doubled or doubled their levels of neutral antibodies. The question is whether the antibody levels that cause the first dose are sufficient, or whether there are other types of immunosuppression with the vaccine that leads to immunity.
“Just because it’s higher in neutralization of response doesn’t mean it’s more effective,” said Paul Offit, director of the Vaccination Education Center at Philadelphia Children’s Hospital. an immune response that comes with the first dose is enough and no more is needed to get better. “
Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels.
Johnson & Johnson
‘The proof is in the mud’
The answer to the question, of course, comes from the results of a Level 3 clinical trial. Carlos del Rio, a distinguished professor of medicine at Emory University School of Medicine, said: “The proof is in the puddle.”
A third authorized vaccine – and one that may be given in a single dose – could help reshape the fight against Covid-19 pandemic disease, even if limited supply for a period of time.
“Part of the problem is our two-dose agreement,” del Rio said. “If we can get a single-dose vaccine, the J&J vaccine has undoubtedly become the world’s preferred vaccine. “
Two Phase 3 studies are underway. A 40,000 volunteer study of the single-dose vaccine, conducted in the US, is expected to be read in the next two weeks. A second, similar study is performed using the same vaccine given in two doses, each administered 57 days apart, in case the vaccine is not effective in schedule one. -dose or that there are other benefits, such as the durability of the vaccine, to the administration of a second dose.
Read more: What’s next for COVID-19 vaccines? This is the latest in 11 major programs.
Reasons to be optimistic about the J&J vaccine.
A previous version of the paper published in NEJM was released in September on an introductory server, meaning it was not reviewed by peers. However, the standard paper contains new data on the safety and stability of the vaccine, which includes information on the safety of the shot, the duration of immune responses, and the impact of administration. second dose to the first.
Del Rio is optimistic. He says that after one dose of the standard vaccines – one made by Pfizer and its partner, BioNTech, and another made by Moderna – only 60% of participants appeared to be neutralized. antibody levels against SARS-CoV-2, the virus that causes Covid19. With J&J vaccine data in NEJM, he said, that figure appears to be 90%. Del Rio was an investigator in the Moderna trial.
But Anna Durbin, a professor at the Johns Hopkins Bloomberg School of Public Health, was less optimistic about the levels of protection. In particular, she doubted that a single-dose vaccine would be sufficient for older adults, who do not always elicit as strong an immune response as younger people.
Read more: The lead scientist at the world’s largest healthcare company has told us the key challenge facing J&J and competitors racing to develop a coronavirus vaccine
‘A little gamble’
“I think going with the same dose was a bit of a gamble, and I think it was very responsible for the company to look at a two-dose regimen and a one-dose regimen. dose, “said Durbin, an investigator in trials of the Pfizer vaccine and another in a vaccine tested by AstraZeneca.
Johan Van Hoof, global head of the J&J vaccination division, said both animal data, which had shown strong single-dose protection, and data released Wednesday, had encouraged J&J to try it. single-dose test. But part of the reason, he said, was whether a single-dose vaccine was needed in a pandemic.
World Health Organization Van Hoof said the very good image of a pandemic vaccine is different from a normal one.
“The difference is there to use it in an epidemic situation, where you go for the [largest] vaccination campaign, there are huge benefits to going with a single dose, even if there is ultimately trade – off in terms of stability or protection, “Van Hoof said.
The J & J vaccine could receive an emergency license as early as next month
If the result of the test, which is expected in the next few weeks, is positive, the data will be submitted to the Food and Drug Administration, establishing an emergency use permit in February. But then there will be the question of how quickly the vaccine can be made. On Tuesday, on a call with reporters, Moncef Slaoui, head of the government’s Operation Warp Speed program, said the ramp could take time.
He said doses of “one million million” would be available in the second half of February, and that efforts were being made to increase that number. There would be more in March, and many more in April, Slaoui expected.
Johnson & Johnson said that, without regulatory approval, it was too early to offer monthly estimates of the number of doses available.
“We have begun to implement our vaccine candidate and are confident in our ability to meet our 2021 procurement commitments signed by governments, and we look forward to sharing more details after some of those measures, “the company said in a statement.