The Food and Drug Administration on Saturday issued an emergency authorization for a Covid-19 vaccine developed by Johnson & Johnson, the third vaccine to be cleared for use in the United States and the first that requires only one dose.
The vaccine, which has not yet been tested in children or adolescents, was cleared for use in adults aged 18 and older.
On Sunday, the Advisory Committee on Immunization Practices — an expert panel that advises the Centers for Disease Control and Prevention on vaccination policy — urged the CDC to recommend use of the vaccine. CDC Director Rochelle Walensky later signed off on the recommendation, paving the way for the vaccine to be deployed.
The addition of J&J’s vaccine to the arsenal could offer a distinct advantage in the effort to vaccinate large swaths of the American public as quickly as possible. The single-shot vaccine doesn’t have the same onerous cold-chain requirements as the two vaccines developed by Moderna and the Pfizer/BioNTech partnership.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Janet Woodcock, acting commissioner of the FDA, said in a statement.
The federal government has purchased 100 million doses of the J&J vaccine, but supplies are expected to be scarce until at least April. In a call with reporters late Saturday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said vaccine would be shipped “as early as next week” and that an “increasing number of doses will be available over the coming months.”
The FDA’s decision came after an outside panel of experts unanimously recommended on Friday that regulators authorize the vaccine, which was developed by J&J’s vaccine division Janssen Pharmaceuticals. The shot was found to reduce cases of moderate to severe Covid infection by 66.1%, starting 28 days after the single shot. Results from a multi-country study, released in late January, suggested the vaccine worked better in some regions of the world than others. In the U.S., the vaccine was 72% protective.
An FDA analysis of the J&J data suggested the vaccine was slightly less effective against a virus variant first spotted in South Africa, known as B.1.351. Another variant, known as P.2., didn’t appear to erode the vaccine’s protection.
J&J is also conducting a trial in the United States of a two-dose vaccine, with the doses given eight weeks apart. The results from that 30,000-person trial are not expected until sometime in May. During Friday’s meeting of the expert panel, several members questioned whether that trial will show that the J&J vaccine really should be given in a two-dose regimen. But Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, suggested if the results point to a second dose being needed, that can be addressed when J&J files for full licensure of its vaccine.
The approval for all adults comes despite the fact that the data on elderly adults from the company’s Phase 3 study were limited. Some of J&J’s data also raised questions about how well the vaccine works in adults 60 and older who have comorbidities, or underlying medical conditions. The committee ultimately voted unanimously to recommend the vaccine be used in those 18 or older, without any restrictions on age.
FDA reviewers were confident that the differences in effectiveness for people older than 60 who have comorbidities may dissipate with more data, Marks said.
“Obviously we will watch that watch as additional data come in, but at this time there is no concern about reduced efficacy in the older population,” Marks said.
Moderna’s vaccine is also authorized for use in those 18 and older, while the Pfizer/BioNTech vaccine can be given to those 16 and older. J&J plans to launch a trial in adolescents soon, and has also said it plans to study the shot’s safety and efficacy in people who are immunocompromised in the third quarter of this year.
Common side effects of vaccination in the study included injection site pain, fatigue, and muscle aches. While unexpected side effects occurred at the same rate in the vaccine and placebo groups — about 0.5% — some rare conditions appeared more frequently in participants who received the vaccine. Blood clot-related issues appeared in 15 volunteers who received the vaccine, compared to 10 in the placebo group. The FDA has said it would recommend monitoring for such events after an EUA is granted.
The CDC has also been monitoring cases of anaphylaxis, a severe and potentially life-threatening allergic reaction, in the vaccine rollout. There have been a small number of cases reported after receipt of both the Pfizer and the Moderna vaccines. Macaya Douoguih, head of clinical development and medical affairs for Janssen, told the advisory panel on Friday that one participant in an open-label study in South Africa developed anaphylaxis after receiving the vaccine. Prior to that, there had been no reported cases of anaphylaxis in the company’s studies.
There are several other vaccines still being tested that have not yet been authorized in the U.S., including candidates from AstraZeneca and Novavax.
This story has been updated with information from a meeting of the Advisory Committee on Immunization Practices and with additional comment from FDA officials.
I note the article mentions reduced efficacy against P2 from Brazil.
But there is no mention of efficacy against P1.
I also note there is no mention of efficacy against B1452 from South Africa.
I realize this may not be the conventional way things are done, but considering the extreme important to the world – why don’t we send researchers into Manaus and the area of South Africa most impacted by the variant- and start injecting people, fast enough, in big enough numbers, to find out, in a short period of time, if the vaccine will work or not?
Obviously this is dangerous for the people who would go – perhaps it could be done by people who are already on the front lines in these places – but however it is done, we need this information very badly.
I understand Pfizer and Moderna are working on new vaccines to protect against the variants – but, even with all the talk of turning on a dime with mRNA vaccines, the new ones will not be into peoples arms for months. probably towards the end of the year, if all goes well.
is it worthwhile to keep on injecting the Pfizer and Moderna vaccines in the US, considering the presence of both South African and Brazilian variants here already? I have no idea- but it seems pretty certain really knowing their efficacy is a crucial part of figuring that out. It also seems likely we would know within a couple months of putting the vaccines into arms in a place with an outbreak.
Besides efficacy, there is the question of Antibody Dependent Enhancement – if the vaccines we are using here knock down the original type by 95% – but ENHANCE infection by one of the other types – P1, B1452, or any other – that would be really important to know, ASAP. This may be very unlikely, none of the science press seems to be talking about it now, but if there is any chance of that – vaccinating hundreds of millions worldwide, with a vaccine which causes ADE could be the biggest disaster in modern history.
I am very concerned we still do not seem to have effective leadership which is treating this as an ongoing war.
I have multiple allergies and I can only
Take non generic medicine. I’m allergic to Tylenol, sulphur, dyes, certain antibiotics, food allergies, and fillers in drugs generic. Certain chemicals make me sick. Do you think
I could get the Johnson and Johnson
I’ve had ablation surgeries and I’m
Ok now just on Propaphine. Healthy otherwise with a restricted diet no gluten or wheat. MSG gives me a rapid heart beat. I’m very careful what
I put in my body. You can see my concerns. Am I a candidate for vaccine? Help me please
I have multiple drug allergies and need to know if the j&.j vaccine is safe for me to take. I am 71 yrs of age and have ILD ,Copd and a pace maker.
Where is it going to be available?
I am concerned about the variants, and concerned we are not being given the bad news.
The datum reported for JJ efficacy against South African variant is 57%. The standard to approve the first vaccines was 50% – so this is just barely over that, but for a variant which may be more contagious.
Approving the JJ when original Wuhan variant is in a steep decline, but variants are rising, seems odd. It seems likely it will not do a lot to stop the rise of the variants, and CDC obviously must know that.
I understand better than 57% (because for now, a lot of the infections are original type) is a good vaccine, but using a low efficacy vaccine, when you have or soon will have, much better, indicates desperation, doesn’t it? The CDC and FDA seem to believe they do not have the option of waiting until mid to late summer to get the mRNA vaccines to everyone.
OR, OR, they do not believe the mRNA vaccines are going to be much better than 50% efficacious against the variants anyway, so best to get what you have into arms ASAP.
Combined with advice to double up on masks, it looks like CDC is very scared but will not be forthright about it. I mean, they tell us to be more careful, but they do not explain why, I am not sure that is adequate.
I
I need to clarify – the efficacy of the J&J vaccine in testing in South Africa was reported as 57% – that does not mean, however, that the efficacy of the vaccine against the South African variant is 57% = not all of the cases in South Africa where the testing was taken place were due to the new variant – so, the efficacy against the variant is likely less than 57% – probably below the 50% threshold originally required by FDA for the first vaccines.
And on top of that, no one talks about the Brazilian variant or Japanese variant. I am not sure what that is about but the worst case I can think of it, maybe it is too scary to openly talk about?
Very good reports. Congratulations
Seriously no info on if this is a mRNA vaccine, a traditional vaccine or something else? Pretty weak.
Indeed. JNJ uses a modified adenovirus platform as a carrier (same as for many flu vaccines, so known-safe) with double-strand DNA in/on it that targets to disable the virus’ spike protein (the miserable culprit that pries open human cells). The other two vaccines are single-strand genetic material or messenger RNA (mRNA) (this is half of a DNA double helix, sort of a construction-unit).
It’s an adenovirus vector vaccine.
I agree. Is this another rna variant?