In a vote of 10 to 4, a committee of the US Centers for Disease Control (CDC) on April 23 decided to lift the temporary suspension on the use of the COVID-19 vaccine manufactured by Johnson & Johnson / Janssen. The U.S. Food and Drug Administration (FDA) and the CDC temporarily suspended vaccination with the J&J vaccine on April 13 after six reports of unusual blood clots in the brain occurred among nearly 7 million people vaccinated with the J&J vaccine. injection in the United States.
The group of 15 independent experts was under pressure to make a decision on the safety of the vaccine, which is the only single-injection vaccine for COVID-19 currently licensed in the U.S. But after an initial meeting on April 14, the group decided he needed more information.
During the past week, nine more cases of unusual blood clots, called cerebral venous sinus thrombosis (CVST), have been reported, bringing the total to 15 cases so far. All 15 occurred in women and most were in their 30s. However, because it is still among several million people who had recently been vaccinated with the injection, the CDC vaccine safety experts still believed the overall risk was very small.
To contextualize these 15 cases, Dr. Sara Oliver, of the CDC National Center for Immunization and Respiratory Diseases, and her team presented data from the models they built to estimate how the 11-day break in the use of the J&J vaccine has influenced COVID-19 cases, hospitalizations and death. The models showed that if the vaccine were reinstated for all adults over the age of 18, there would be 26 to 45 additional cases of rare blood clot side effects in the next six months, but 800 to 3,500 fewer hospitalizations. in intensive care and anywhere from 600 to 1,400 fewer deaths. If officials restricted the vaccine to only people over the age of 50 – which might make sense given that younger people are more at risk of the side effect of clotting – they would expect two to three additional cases of clotting compared to 300. -1,000 fewer ICU hospitalizations and 40 to 250 fewer deaths.
Oliver also analyzed the data at the individual level and reported that for every million doses of the vaccine given to women aged 18 to 49 – the group at highest risk of a coagulation side effect – 13 cases of coagulation could be expected. coagulation.
J&J representatives at the meeting reiterated that the vaccine starts protecting people from disease within days of administration, and that the company’s clinical trial data showed it was 85% effective in protecting people from COVID-19. severe, even against new variants of the virus. They also pointed out that theirs is the only licensed vaccine that only requires a single dose and that it can be shipped and stored in freezing temperatures rather than extremely cold, making it more accessible to most of the world. “Johnson & Johnson’s vaccine is central to the effort to end the pandemic,” Dr. Joanne Waldstreicher, the company’s chief medical officer, told the committee. “Our vaccine provides access to disadvantaged people as well as people who typically face barriers in accessing health services. Our concern is that with continued vaccine restriction we are not only delaying vaccination, but potentially leaving part of the United States unvaccinated. If the unvaccinated population is large enough, this could risk achieving herd immunity. “
Waldstreich said the company is in favor of adding a clotting risk warning label, similar to how the risk of anaphylaxis is now included on the label for Pfizer-BioNTech and Moderna mRNA vaccines.
Throughout the day, committee members noted that the data appeared to show that the risk of clotting was rare and that the benefits of vaccination with J&J shot outweighed that risk. But they discussed how to warn people, especially younger women, about the potentially serious side effect. Some welcomed a wording that highlighted the risk specifically, pointing out that women under 50 should have the option to choose another vaccine. This is how the UK decided to launch the AstraZeneca vaccine, giving people under 30 the choice of getting an alternative injection. Other committee members argued that specific blood clotting characterization would not be consistent with how the other side effects of any vaccine, including other COVID-19 vaccines, are managed; said blood clotting risks should be part of the language already FDA approved, as follows:
“Reports of adverse events following the use of Janssen COVID-19 vaccine under emergency use suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites … combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following Janssen COVID-19 vaccine have occurred in women aged 18 to 49 years; some have been fatal. under study specific risk factors for thrombosis with thrombocytopenia following the Janssen COVID-19 vaccine and the level of potential excess risk due to vaccination. Based on currently available evidence, a causal relationship between thrombosis with thrombocytopenia and the vaccine Janssen COVID-19 is plausible … Recipients of the Janssen vaccine should be instructed to seek immediate medical attention if they develop deficiency breathing, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headache or blurred vision) or petechiae beyond the vaccination site. “
A secular version of that warning is included in the fact sheets that people who get vaccinated receive when they get their shot.
Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine, was one of four members who voted against the recommendation. “I did not object to the recommendation,” he told the committee explaining his vote. “I opposed the absence of any kind of leadership on our part. I am very sorry that we have not chosen to focus on the knowledge we have that this unique cluster side effect is almost certainly vaccine related and that there are options. “
If the director of the CDC, Dr Rochelle Walensky, accepts the group’s recommendation to reinstate the J&J vaccine with a modified warning, it will be up to the CDC, state public health departments and individual providers to inform people about the risks of the vaccine. injection. The CDC plans to publish the updated EUA warning on both its website and in its weekly MMWR publication on April 27, and information sheets for vaccine providers and individuals will also be updated in the coming days.
Committee members discussed the burden it would place on some providers, particularly those with smaller vaccination programs, who now, ideally, would have to stock two different vaccines in case some people decide not to get the J&J shot. . They also considered the possibility that some women uncomfortable with the J&J injection would end up not getting vaccinated or delaying vaccination altogether if another option wasn’t immediately available. “You entrust us making this vaccine available and distributing it, the responsibility of making sure the public is aware of the risk,” said Dr. Jose Romero, professor of pediatrics at the University of Arkansas, director of the health department of the United States. ‘Arkansas, and chairman of the committee. “Our responsibility as physicians is to make sure women understand this risk and, when possible, have alternatives while administering the vaccine.”