POST 221. December 18, 2021. CORONAVIRUS. “Johnson & Johnson’s Covid vaccine was going to be a shot for the world. Now, under the weight of a mountain of bad PR, one wonders if the world will want it.”

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“The U.S. Centers for Disease Control and Prevention on Thursday recommended Americans choose to receive one of two other authorised COVID-19 vaccines over Johnson & Johnson’s (JNJ.N) shot, due to rare but sometimes fatal cases of blood-clotting.

The CDC’s move came after its Advisory Committee on Immunization voted unanimously to make the recommendation in favour of the vaccines made by Moderna Inc (MRNA.O) and Pfizer (PFE.N)/BioNTech (22UAy.DE) over the J&J shot.

Fewer Americans have received the J&J shot than the other two vaccines by a significant margin. Out of more than 200 million fully vaccinated people in the United States, around 16 million received J&J’s vaccine, according to CDC data.

J&J said in a statement that the safety and well-being of those who use their vaccine is its top priority and it looks forward to working with the CDC on the next steps.

Cases of thrombosis with thrombocytopenia syndrome (TTS), which involves blood clots accompanied by a low level of platelets, have previously been reported in recipients of the J&J vaccine. The highest reporting rates are in women under 50.

The CDC said that the rate of such incidents is higher than previously estimated, both in women and men. The agency has identified more than 50 cases of TTS in the U.S., about 3.83 cases per million J&J doses administered.

At least nine people have died following the blood clotting incidents in the United States, the CDC has said.” (A)

“COVID-19 vaccines produced by Johnson & Johnson and China’s Sinopharm, as well as the Russian-made Sputnik V, were found to provide little or no protection against the newly emerging Omicron variant, according to a study out this week.

Driving the news: The study, which was published as a preprint and isn’t yet peer-reviewed, found that just three out of 13 people who were fully vaccinated with China’s Sinopharm vaccine produced neutralizing antibodies against Omicron.

One out of 12 people with the Johnson & Johnson vaccine exhibited neutralizing antibodies.

None of the 11 with Russia’s Sputnik V vaccine revealed protection, per the study conducted by researchers at the University of Washington and Swiss drugmaker Humabs Biomed SA.

The study also found that the best protection against Omicron appears to come from both having a prior COVID-19 infection and two doses of a Pfizer vaccine.” (B)

“Johnson & Johnson’s Covid vaccine was going to be a shot for the world. Now, under the weight of a mountain of bad PR, one wonders if the world will want it.

On Thursday, a panel advising the Centers for Disease Control and Prevention voted unanimously that the shots developed by Pfizer and Moderna should be recommended over the J&J one. That won’t matter much to J&J as a business — in the third quarter the vaccine generated only $500 million of the company’s $23 billion in revenue.

But the recommendation is confusing news for the public, a slight to one of the world’s largest drug companies, and a disappointing setback for researchers, both inside and outside J&J, who hoped that the shot and the technology behind it would make a huge difference in the fight against a raging global pandemic. Decisions that J&J made seemingly in the service of public health, not commerce, may have hurt the vaccine’s chances, and in the end, the company was bested by one of the central facts of drug development: Biology is unfair, and, besides, you can’t be smart enough to beat bad luck.” (C)

“Ten months ago, the one-dose Johnson & Johnson vaccine created partly by researchers at Beth Israel Deaconess Medical Center was hailed as the most convenient of three coronavirus shots available in the United States.

Now, with a recommendation by the Centers for Disease Control and Prevention that people instead choose the rival shots, experts say the J&J vaccine has received a huge blow with far-reaching implications.

J&J’s shot has played only a modest role in the United States, accounting for less than 4 percent of the roughly 490 million doses administered, but 90 countries have authorized it as part of their immunization campaigns. The CDC said late Thursday that the more popular Pfizer-BioNTech and Moderna vaccines were preferable because the J&J shot poses a higher risk of potentially fatal blood clots than first estimated, although they are still rare. That’s likely to deter other nations from using it, experts say.

It could also stiffen resistance by some people in the United States and abroad to get any COVID vaccine as cases caused by the Omicron variant surge.

“What I fear is that people who were hesitant to get a vaccine will see this as all the more reason why I shouldn’t get one, even though this problem is not a problem of mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

The Pfizer and Moderna vaccines rely on technology called messenger RNA to stimulate an immune response in the body. That has not been associated with the rare blood-clotting condition, known as thrombosis with thrombocytopenia syndrome. The J&J vaccine spurs immunity by using a harmless cold virus to deliver part of the spike protein on the surface of the coronavirus into human cells, triggering the production of disease-fighting antibodies and T cells….

Several health experts said the CDC’s recommendation is likely to discourage countries from using other adenovirus vector vaccines such as the one-dose vaccine from AstraZeneca, which has also been linked to the rare clotting condition. The AstraZeneca vaccine is not authorized in the United States.” (D)

“CDC Director Dr. Rochelle Walensky said Friday she is standing by an advisory committee’s decision to keep Johnson & Johnson’s Covid-19 vaccine on the market despite a rare, but serious, side effect that has caused blood clots in some people.

“Given the current state of the pandemic, both here and around the world, any vaccination is better than no vaccination,” Walensky said during a press briefing by the White House Covid-19 response team. “Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson’s Covid-19 vaccines.“”(E)

“Covid booster shots are “optimal care” as the deadly virus continues to mutate and spread, but the U.S. government is staying firm for the time being on the definition of fully vaccinated, top U.S. infectious disease expert Dr. Anthony Fauci said Sunday.

Currently, two doses of the Pfizer-BioNTech or the Moderna vaccines or one dose of the Johnson & Johnson vaccine provide full vaccination. Health officials will continue to evaluate whether that definition needs to change, Fauci said on ABC’s “This Week With George Stephanopoulos.”

“I think if you look at the data, the more and more it becomes clear that if you want to be optimally protected you really should get a booster,” Fauci said. “It’s the optimal care.”

The push for booster shots comes in tandem with the rise in cases of the omicron coronavirus variant. Twenty-five states so far have detected the variant, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in a Friday briefing. Officials expect that number to continue to rise.

It’s still too early to tell what the long-term impacts of the virus are, but early data suggests those who contract the omicron variant experience mild illness. Vulnerable patients who are older, unvaccinated or have underlying conditions have a much higher risk of developing severe disease, Maria Van Kerkhove, the World Health Organization’s technical lead on Covid-19, said in a press briefing.

As of Sunday, the U.S. was approaching 800,000 coronavirus-related deaths.

The new variant has pushed some government officials to reinstate health restrictions to slow the spread. On Monday, New York will implement its statewide mask mandate, which requires protective face coverings to be worn in public places and businesses, unless proof of vaccination is required.

“This variant moves fast, we have to move faster,” New York City Mayor Bill de Blasio said Sunday on CNN’s “State of the Union.”” (F)

“What booster should I choose if I got Johnson & Johnson?

You should get a Pfizer or Moderna booster, the CDC says, at least two months after your Johnson & Johnson vaccine. This “mix and match” approach for COVID-19 boosters was authorized by the FDA after early studies from the US and other countries found it’s safe and effective. In fact, some research shows that people who originally got J&J’s shot have a better response to Moderna’s and Pfizer’s booster than to another shot of Johnson & Johnson.

Boosters are recommended for everyone age 16 and up for maximum protection against the omicron variant, which appears to lower the effectiveness of all the COVID-19 vaccines, as well as protection from past COVID-19 infections.

Preliminary research from a virologist in South Africa suggests that while Johnson & Johnson appears to lose its antibody protection against omicron, real-world evidence suggests it still provides protection against severe disease and death. (There are more measures to immunity than antibody response.) Johnson & Johnson said in late November the company is testing the vaccine against the new variant.

However, you can still receive Johnson & Johnson’s booster if you choose. The reason that the CDC is now recommending Pfizer and Moderna over Johnson & Johnson is because neither mRNA vaccine carries the rare but dangerous side effect, and both also appear to be more effective than J&J. What’s more, vaccines are widely available in the US now, unlike earlier in the pandemic when the public health advice was to get whatever vaccine you could as soon as you could. (According to a Thursday CDC release, there are nearly 100 million doses of mRNA vaccines “in the field for immediate use.”)” (G)

• A.CDC recommends Moderna, Pfizer COVID-19 vaccines over J&J’s, By Michael Erman, https://www.reuters.com/business/healthcare-pharmaceuticals/blood-clot-rates-after-jj-vaccine-higher-than-previous-estimates-cdc-advisers-2021-12-16/
• B.Study: J&J vaccine provides little or no protection against Omicron, by Erin Doherty, https://www.axios.com/sinopharm-jj-sputnik-omicron-vaccine-1fddee76-155b-4d66-bd7b-e8aaf7707f63.html
• C.The tragedy of Johnson & Johnson’s Covid vaccine, By Matthew Herper, https://www.statnews.com/2021/12/17/the-tragedy-of-johnson-johnsons-covid-vaccine/
• D.Recommendation against J&J vaccine could have ripple effects, By Jonathan Saltzman, https://www.bostonglobe.com/2021/12/17/nation/recommendation-against-jj-vaccine-could-have-ripple-effects/
• E.CDC Director Dr. Walensky says any vaccine is better than none in recommending J&J’s Covid shots, by Sevanny Campos, https://www.cnbc.com/2021/12/17/cdc-director-says-any-vaccine-is-better-than-none-in-recommending-jj-covid-shots.html
• F.Covid booster is ‘optimal care,’ but fully vaccinated definition stays put, Fauci says, by Jessica Bursztynsky, https://www.cnbc.com/2021/12/12/covid-booster-is-optimal-care-but-fully-vaccinated-definition-stays-put-fauci-says.html
• G.What to know if you got Johnson & Johnson’s COVID vaccine, by Jessica Rendall, https://www.cnet.com/health/johnson-and-johnson-covid-booster-omicron-variant/