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Johnson & Johnson on Tuesday morning asked federal regulators to authorize a recall for adults, becoming the third coronavirus vaccine maker to do so.
The company said that a second injection of its vaccine about two months after the first significantly increases protection, to 94%, against moderate to severe disease. Other coronavirus vaccines have been given in two doses, but Johnson & Johnson’s is a single dose.
The Food and Drug Administration cleared boosters for many Pfizer-BioNTech vaccine recipients last month, and Moderna is seeking clearance of boosters for its inoculation. Regulators could vote on Moderna and Johnson & Johnson’s demands as early as this month.
Senior federal health officials have been privately convinced for some time about the need to offer a booster to recipients of the Johnson & Johnson vaccine.
A recent study from the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was 71% effective against hospitalizations due to Covid-19, compared to 88% for Pfizer-BioNTech and 93% for two-dose vaccines of Moderna. Further research found that recipients of Johnson & Johnson were more likely to suffer from breakthrough or symptomatic infections of Covid-19 than recipients of the other two vaccines.
Johnson & Johnson’s own study cited better results, concluding that its vaccine was 81 percent effective against hospitalization and 79 percent against infection. The company said its study also found that the protection offered by its vaccine did not diminish over time, as did the protection against Pfizer-BioNTech’s vaccine.
Nearly 15 million Americans have been vaccinated with the Johnson & Johnson vaccine, compared with 102 million fully vaccinated with the Pfizer-BioNTech vaccine and nearly 69 million with Moderna.
On Tuesday afternoon, Dr. Peter Marks, the FDA’s main vaccine regulator, suggested that federal officials favor additional injections for all three vaccines. “The data seems to show that the booster shoots appear necessary,” he said.
Speaking at a virtual town hall organized by the Covid-19 Vaccine Education and Equity Project advocacy group, he added: eligible for booster injections. But we’ll have to see what our advisers say.
Some scientists are unsure whether it would be better to give a Johnson & Johnson booster shot after about two or six months. Johnson & Johnson’s submission to the FDA shows that when a booster was given six months after the initial injection, antibody levels increased nine times in a week and 12 times in a month.
Some research from the National Institutes of Health also indicates that Moderna’s vaccine may work even better as a booster for Johnson & Johnson’s vaccine.
The State of Vaccine Mandates in the United States
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- Vaccination rules. On August 23, the FDA granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 years of age and older, paving the way for mandates in the public and private sectors. Such warrants are authorized by law and have been confirmed in court challenges.
- College and universities. More than 400 colleges and universities require students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California has become the first state to issue a vaccination warrant for all educators and to announce its intention to add the Covid-19 vaccine as a requirement to attend school, which could begin as early as next fall. Los Angeles already has a vaccination mandate for public school students ages 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which went into effect Oct. 4 after delays due to court challenges, appears to have sparked thousands of minutes of gunfire.
- Hospitals and medical centers. Many hospitals and large healthcare systems require their employees to be vaccinated. Mandates for healthcare workers in California and New York state appear to have forced thousands of holdouts to receive injections.
- New York City. Proof of vaccination is required from workers and customers for indoor meals, gymnasiums, shows and other indoor situations. City education staff and hospital staff also need to be vaccinated.
- At the federal level. September 9 President Biden has announced a vaccination mandate for the vast majority of federal workers. This mandate will apply to employees of the executive, including the White House and all federal agencies and members of the armed forces.
- In tthe private sector. Mr Biden demanded that all businesses with more than 100 employees require weekly vaccination or testing, helping to propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
“We look forward to our discussions with the FDA and other health authorities to inform their decisions regarding boosters,” said Dr. Mathai Mammen, a key research and development manager at Johnson & Johnson. “At the same time, we continue to recognize that a single-injection Covid-19 vaccine that provides strong and long-lasting protection remains a crucial component in immunizing the world’s population. “
The FDA and the Centers for Disease Control have been debating whether to boost the vaccine’s effectiveness with booster shots for weeks. After heated debates with experts from external advisory committees, the agencies decided late last month to offer a booster shot to a wide range of adult recipients of the Pfizer-BioNTech vaccine.
Eligible people include people 65 years of age and older and those who live in long-term care facilities, who have underlying health conditions or who are at greater risk of exposure to the virus due to their work or of their institutional environment.
Federal officials are expected to push this month for the same eligibility categories for booster shots of the other two vaccines. There is also pressure to include middle-aged people among those generally eligible. The FDA advisory group is expected to address the issue of a third injection of Moderna’s vaccine on October 14, a day before considering Johnson & Johnson’s request.
“Our goal at the end of the day is hopefully to have a harmonized approach to recalls for the three different vaccines,” Dr Marks told City Hall. His remarks were reported by CBS News and other media.
On Monday, federal regulators in the European Union went further than US regulators, allowing booster shots for all Pfizer-BioNTech beneficiaries 18 years of age or older.
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