Johnson & Johnson COVID-19 vaccine is not recommended in the USA: what's wrong with it

The country's public health official has advised people looking for the safest and most effective COVID-19 vaccines and boosters to make Pfizer-BioNTech or Moderna instead of Johnson & Johnson. Writes about it The Washington Post.

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Rochelle Walenski, director of the Centers for Disease Control and Prevention, approved the rule hours after a unanimous vote by a vaccine agency advisory group that raised concerns about the increased risk of blood clots associated with Johnson & Johnson's vaccines.

“The updated recommendation underscores the Centers for Disease Control and Prevention's (CDC) commitment to providing real-time scientific information,” Walensky said, urging all Americans to get vaccinated and get booster shots.

Nine deaths - among seven women and two men - were confirmed due to blood clots until September. Seven of these patients, aged 28 to 62 years, had underlying health conditions including obesity, hypertension and diabetes. Officials are considering including two more deaths while they await more complete medical information. Dozens more people became seriously ill.

The news is the latest blow for Johnson & Johnson, whose single-dose, no-storage vaccine has been proposed as a solution that promises to make it hugely popular. But reports of less comparative vaccine efficacy, as well as a blood clot problem, have led to much lower utilization.

This move is likely to make it difficult to vaccinate the homeless and people in prisons due to the great difficulties in using and transporting the two-dose vaccines. But the effect is expected to be greater overseas than in the United States, which has ample supplies of other vaccines.

The CDC noted in a statement that the supply of mRNA vaccines in the US is extensive, with nearly 100 million doses in the field for immediate use. The CDC's action is following similar guidelines from other countries, including Canada and the United Kingdom.

The CDC and its Advisory Committee on Immunization Practices rarely recommend a policy of preference. So far, the United States has viewed all three vaccines available to Americans as equal choices because early supplies were limited and large studies have shown that they all provide reliable protection.

On the subject: Some countries have changed the concept of 'full vaccination': now you need 3 vaccinations against COVID-19

Johnson & Johnson said it “remains confident in the overall positive benefit and risk profile of its COVID-19 vaccine. Research has shown that the Johnson & Johnson vaccine generates strong antibodies and cellular immune responses, as well as long-term immune memory and protection against different strains. ”

The company said the vaccine remains an important choice for those who "cannot or do not want to take two shots, or who will remain unvaccinated without an alternative to mRNA vaccines." The department noted that the ease of storage and transportation “makes this vaccine a vital tool” for many with low and middle incomes, sometimes the only option.

But commissioner Pablo Sanchez, a professor of pediatrics at Ohio State University, said he was seriously concerned about the Johnson & Johnson vaccine.

“I simply cannot recommend a vaccine that is associated with a disease that can cause death,” he said and urged families who are his patients to stay away from the vaccine.

The Working Group believes that exemptions should be made for those who have had allergic reactions to mRNA vaccines or for those who do not have these vaccines available. People who cannot or do not want to receive the mRNA vaccine should get the Johnson & Johnson vaccine.

Federal authorities initially suspended use of the Johnson & Johnson vaccine for 10 days in April after six women experienced blood clotting problems, the only known cases at the time among more than 7 million people who have received the vaccine in the United States. One of the patients died. The pause was lifted after an extensive safety review determined the vaccine's benefits outweighed the risks.

But now, members of the advisory committee have learned new evidence indicating that the problem is broader than originally anticipated, although rare. As of August, 54 confirmed cases out of approximately 14 million doses administered. All patients are hospitalized; the average age of the patients was about 44 years. Officials review the data to make sure the numbers are not underreported.

Those who died fell ill quickly, were admitted to hospital on average three days after onset of symptoms, and died within one day of hospitalization.

“We've struggled to analyze these cases by how quickly patients deteriorate, leading to death,” said Isaac See, a CDC physician who presented the data. “We have not yet observed a single case... after revaccination with Johnson & Johnson. Although it is worth noting that the number of booster doses administered was small.”

CDC spokeswoman Sarah Oliver said the working group supported the preferred recommendation based on stronger indicators of the efficacy and safety of mRNA vaccines. There has been controversy over the wording “preferred”, with some arguing that the term is not strong enough to reflect the strength of the recommendation.

"It's like saying, 'I prefer strawberry jelly to grape jelly,'" said Helen Keipp Talbot, an infectious disease expert at Vanderbilt University. “I don’t think that’s a strong enough wording.”

Members of the group discussed, among other things, the ethics of limiting the use of Johnson & Johnson's vaccine. If it is not available, life-saving vaccinations may be denied to some. However, if it continues to be used, vulnerable populations may be at greater risk.

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During the public comment session, Claire Hannan, executive director of the Association of Immunization Managers, spoke about the "unique role" of Johnson & Johnson vaccinations, especially for people who are homeless or living in prisons. This vaccine is easier to use because it does not require ultra-cold storage.

“Single-dose vaccination, among other things, provides an affordable option for those who need a quick vaccination for travel or work,” Hannan said.

However, the impact of the recommendation is likely to be much stronger in other countries where options other than Johnson & Johnson are more limited or not available. According to the World Health Organization (WHO), the vaccine is currently approved for use in 90 countries.

WHO spokeswoman Wynn Boelt said her global vaccine safety advisory committee "is reviewing the data and taking into account the CDC's recommendations."

Jen Cates, senior vice president of the Kaiser Family Foundation, is worried about the international implications. She said there could be a potential "deterrent effect" not only for the Johnson & Johnson vaccine, but also for the AstraZeneca vaccine in other countries.

But several experts said that the main advantage of the J&J vaccine as a single-use vaccine is no longer relevant, since even dioecious vaccine boosters have become necessary to protect against weakened immunity and the mutating virus.

“It’s not one dose and you’re done; it’s one dose and you still need another,” one practitioner said during the discussion.

On the subject: The Moderna vaccine is not recommended for people under 30 years old: a dangerous side effect can develop

The working group heard, among other things, the first vaccine safety data for children aged 5 to 11 who received the Pfizer vaccine, recently approved by the US Food and Drug Administration (FDA).

More than 7 million vaccines have been given to this age group, according to CDC spokesman John Soo, with most side effects being mild to moderate and more likely to occur after the second dose. Most of the complaints were related to fever, headaches and fatigue that passed quickly. Few children sought medical attention, and about 1% were missing school.

Eight children — four boys and four girls — developed a mild form of myocarditis, a rare heart inflammation associated with the mRNA vaccine. Two others with complex medical histories died after vaccination and their cases are still being reviewed.

One of them was a 5-year-old girl who had cerebral palsy and a seizure disorder. The second is a 6-year-old girl with a traumatic brain injury. Ten days after vaccination, she developed a fever and increased weakness, and later died.

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