Independent advisers to the Centers for Disease Control and Prevention (CDC) said that Johnson & Johnson’s Covid-19 vaccine must be distributed with a warning label attached, But that the benefits of preventing Covid-19 still outweigh the risks of rare blood clots.
The change comes after distribution of the Johnson & Johnson vaccine was temporarily halted while scientists investigated rare but dangerous blood clots with low platelet counts linked to the injection.
“This pause was essential to our ability to inform the public, inform clinicians, and acquire more data for presentation and analysis,” said Dr. José Romero, chair of the CDC’s committee on immunization practices, who advises on how better use vaccines. The committee voted 10 to 4 in favor of recommending the vaccine for adults 18 years of age and older. There was one abstention.
More than 570,000 Americans have died from Covid-19, according to Johns Hopkins University, and 31 million people have been infected with Covid-19 in the US, according to the CDC.
Health authorities from the CDC and the Food and Drug Administration (FDA) put the distribution of the Johnson & Johnson vaccine on April 13 “on hiatus” while six cases of very rare blood clots were investigated in women ages 18 to 49. years.
Since the hiatus, scientists have found nine more cases of clots. That means that among the more than 7.98 million Johnson & Johnson doses distributed, vaccine safety monitoring systems found 15 cases in total. The panel’s physicians said that the fact that researchers were able to identify the very rare associated disorder shows the strength of the control of vaccine safety in the United States.
All confirmed cases were among women, most were middle-aged. Two were cases in women over 50 years of age. The Johnson & Johnson clinical trial also found a case in a man and cases among men are being investigated.
Put another way, if 1 million people were vaccinated with the Johnson & Johnson vaccine, 2,000 fewer people would be expected to die from Covid-19, 6,000 fewer hospitalized, and seven people would develop serious blood clots associated with the vaccine. .
However, the individual risk for women under 50 is higher. Among 1 million people, 12 deaths from Covid-19 and 657 hospitalizations are expected to be avoided, and 13 cases of the blood clotting disorder are expected, according to the CDC.
A description of the risks and symptoms of blood clots would appear in a patient information sheet distributed with the vaccine. In the general population, between 0.7 and 1.6 people per million develop the specific type of blood clot with a low platelet count associated with the vaccine.
It is not uncommon for the committee to modify recommendations as data is collected from millions of people. CDC and FDA health authorities will consider the new recommendations from independent advisers, and are expected to act quickly on the advice. Although health authorities do not always follow the advice of their independent expert advisers, they do so more frequently.
Those who opposed the measure said the recommendation did not issue a strong enough warning. Beth Bell, a public health professor at the University of Washington who voted against the measure, did not object to resuming distribution of the Johnson & Johnson vaccine, she said.
“I am concerned that women are not adequately informed with only [emergency use authorization] fact sheets, ”said Bell.
At the time of the hiatus, authorities said they hoped the high-profile announcement would help uncover any additional cases of the bleeding disorder that had previously been overlooked, and that the suspension would give doctors time to understand how. treat the disorder. Unlike most blood clots, those associated with the Johnson & Johnson vaccine cannot be treated with heparin, a common blood thinner.
Blood clots associated with the Johnson & Johnson vaccine are formally called thrombosis with thrombocytopenia or blood clotting with a low platelet count. Platelets are a component of the blood that helps with clotting. The syndrome has been found to occur after the most common flu-like side effects resolve, between six and 13 days after the vaccine is given.
A similar syndrome has been linked to a vaccine from AstraZeneca, which uses the same vaccine technology, called a viral vector. In both cases, the vaccine manufacturers used a second weakened virus to deliver the genetic payload of the Sars-CoV-2 virus, prompting immunity.
Although the two manufacturers used different types of viral vectors, a chimpanzee virus in the case of AstraZeneca and a human virus in the case of Johnson & Johnson, authorities have said in the past that the conditions linked to the two vaccines are similar. .
Not all experts agreed that a “pause” was the best way to investigate possible side effects. Many argued that it was unnecessary for such a rare side effect and that it could cause further hesitation for the vaccine.
Confidence in the Johnson & Johnson vaccine has declined significantly, the CDC said. In the two days after the announcement, there was a 15% decline in confidence in the Johnson & Johnson vaccine.
Hesitation is already playing an important role in the largest adult immunization campaign in US history, as states now have more open spaces than candidates, especially in areas with large populations of racial minorities and conservative voters.
Local health departments had also planned to use the vaccine to reach the hardest to vaccinate, especially the homeless, incarcerated, homebound or who are seasonal workers.
The recommendation of the advisory committee will not solve all of Johnson & Johnson’s problems. More than 7.9 million Americans have been given a Johnson & Johnson opportunity, and another 10 million wait behind the scenes. But the company has had serious manufacturing problems at a US facility that is expected to produce most of the 100 million doses that the federal government expects the company to deliver by next summer.
George is Digismak’s reported cum editor with 13 years of experience in Journalism