A second dose of the vaccine has been approved under emergency use authorization for people 18 and older at least two months after they receive the first dose.
There was concern among the Vaccine and Related Biological Products Advisory Committee over the small sample size in the data presented from Johnson & Johnson and the lack of review from the FDA.
FDA’s Dr. Doran Fink said “public interest and sense of urgency” led to a rushed hearing and therefore “we were not able to conduct an independent verification of their data sets or their analyses or conduct our own analyses.”
The committee also said the Johnson & Johnson vaccine is a two-dose vaccine, based on data presented on the efficacy of the first dose compared to other mRNA vaccines and the proposed booster dose.
“I think it’s better as a two-dose vaccine,” Dr. Paul Offit said. “It would be hard to recommend this as a single-dose vaccine at this point.”
The voting question was revised as well. The committee voted to approve the booster dose two months after the primary series, refusing to consider a six-month interval between first and second doses.
Some committee members wanted to revise the question to say “additional shot” instead of “booster” to reflect their view that the Johnson & Johnson shot should have always been a two-dose vaccine.
The 19-strong committee voted unanimously in favor of a Moderna COVID-19 vaccine booster shot yesterday after several lengthy presentations on data that shows how an extra dose of vaccine can counteract the waning effectiveness of current shots over time.
Despite all members voting “yes” after lengthy presentations, many members still had concerns over the data they saw from Moderna and the Israel Health Ministry, worried that it did not reflect a fully-rounded picture, and answer questions about the necessity of the boosters - and who should get them.
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The proposal would allow employees to evade punishment from current or prospective employers for pursuing exemptions from vaccine mandates.
“I don’t believe that really and truly we should just throw our freedoms and our rights in a trash can,” Governor Jim Justice said in a news conference.
Under the bill, a doctor or nurse can give signed documentation that an employee has a physical condition preventing them from receiving the COVID-19 vaccine. Employees can also present a notarized certification for religious exemptions.
“If my employer wants to require something, fine. You can still require it. But you’re going to recognize these exemptions. They’re legitimate and they exist,” Raleigh County Republican Brandon Steele, chairman of the House government organization committee, said.
The bill is pending in the state Senate.
Pfizer/BioNTech sent data to the U.S. Food and Drug Administration (FDA) with a request to approve their COVID-19 vaccine to children ages 5 to 11.
The Centers for Disease Control and Prevention (CDC) sent a seven-page document to help states and cities set up expanded vaccination programs.
Pfizer/BioNTech submitted the same data to the European Medicines Agency Friday.
The study tested their vaccine in more than 2,200 children ages 6 months to 11 years. The children in this study received a lower dose than what’s normally given to adults.
The results showed a “strong immune response” in the children and found that the vaccine was safe, the companies said in a statement.
An FDA expert advisory panel is scheduled to publicly debate the evidence at a meeting in late October. If the FDA authorizes vaccines for children, a CDC advisory panel would discuss the data in early November and offer its recommendation to the CDC.
“We are pleased with the unanimous vote by the U.S. FDA Vaccines and Related Biological Products Advisory Committee to recommend a booster of the Johnson & Johnson vaccine,” Dr. Pual Stoffels said in a statement.
According to data from the Indiana Health Department vaccine tracker, 60 percent of the shots administered were booster shots to people who were fully vaccinated.
While the demand for Pfizer boosters has increased following the FDA’s approval in September, the amount of first or second doses received in Indiana has hit its lowest level since the vaccine became widely available last year, the Associated Press reported.
About 49 percent of Indiana’s residents are fully vaccinated, according to the Centers for Disease Control and Prevention.
Dr. Kirsten Lyke from the University of Maryland School of Medicine presented the FDA panel with data from a study on mixing booster shots.
Lyke said the NIH study is adaptive and will include more data on mix and match with the Moderna and Johnson & Johnson booster doses.
The study found that all of the shots resulted in a “boost” of antibodies for recipients. Moderna primary or booster dose recipients had the best antibody responses and there were limited adverse reactions.
More research is needed to determine the correlations between antibody response and protection against infection and severe disease.
The study concluded that heterologous, a mix of vaccine brands, led to a similar or higher antibody response compared to their respective homologous booster responses.
It also found that mRNA vaccine boosters, like Moderna and Pfizer, resulted in a higher level of antibodies in the 28 days after the booster was given.
The committee voted 19-0 in favor of this authorization.
The committee is going to adjust the voting question to decide if an additional Johnson & Johnson should be given at least two months after the first dose.
The committee will only be voting on the first question: if the data support the safety and effectiveness of the Johnson & Johnson as a booster dose for people over the age of 18 at least two months after the first dose is given.
Some committee members want to revise the question to say “additional shot” instead of “booster.”
Johnson & Johnson is presenting the second dose as a booster to the one-shot vaccine and is not looking to change its authorization to a two-dose vaccine.
Committee member Dr. Eric Rubin, editor-in-chief of The New England Journal of Medicine, said the company should focus on a booster dose two months after the first dose.
“If the vaccine isn’t adequate, then it should be boosted in everybody,” Rubin said. He noted that the data for a six-month interval is slim.
“I’m not sure why you’re asking for an indication that would apply to millions of patients with a data set that includes 17 patients.”
Dr. Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, agreed with Rubin and said the Johnson & Johnson vaccine “was always a two-dose vaccine.”
“I think it’s better as a two-dose vaccine,” he said, “it would be hard to recommend this as a single-dose vaccine at this point.”
The CDC’s Amanda Cohn supported that notion, saying the effectiveness of protection with a single dose of the Johnson & Johnson vaccine is not the same as the protection from the Moderna or Pfizer vaccines.
“In our hospitalization network, so in our active surveillance that looks at vaccine effectiveness in hospitalized individuals, we demonstrated that the Janssen vaccine was only 68 percent effective against hospitalization, and this is in adults greater than 18 years of age without immunocompromising conditions, which is both lower than what we saw from that real-world effectiveness presentation and it is also substantially lower than the mRNA vaccines are against hospitalization even with the waning,” Cohn said.
“Additionally there was some other data to suggest that real-world effectiveness is hovering more in the 50 percent to 60 percent [range], and this is from some data from a different surveillance system,” she added.
FDA’s Dr. Peter Marks told the committee Johnson & Johnson may not be telling the whole story.
“There is more data that is out there than what we are seeing,” he said. “There are data suggesting the effectiveness of the vaccine is actually less robust than the company’s presentation here.”
Some of the data sets were very small. One of the studies submitted to the FDA looking into the efficacy of the Johnson & Johnson booster after six months included only 17 people.
Johnson & Johnson said this study still shows robust, compelling responses. The committee seems skeptical.
FDA’s Dr. Doran Fink said the “public interest and sense of urgency” in presenting a second dose based on data for the rush of the hearing.
He said data sets on the Johnson & Johnson booster shot were not submitted to the FDA until recently and therefore the agency could not conduct its usual review process.
“As a consequence of the review time, we were not able to conduct an independent verification of their data sets or their analyses or conduct our own analyses,” he added.
During the committee hearing Friday, FDA’s Rachel Zhang said “except for the immunogenicity assessments of the six-month booster interval,” the datasets for the studies “were not submitted in sufficient time for FDA to conduct an independent review to verify Johnson & Johnson analyses.”
The FDA was also unable to independently verify Johnson & Johnson’s safety data.
Johann Van Hoof, managing director of Janssen Vaccines, is against mixing vaccine brands when administering boosters. He pushed for homologous booster doses, boosting the first Johnson & Johnson shot with a second Johnson & Johnson shot, believing Johnson & Johnson protection is durable.
However, FDA reviewers pointed out the efficacy for the single-dose Johnson & Johnson vaccine has been lower than the efficacy of the other mRNA vaccines.
Johnson & Johnson’s Penny Heaton noted “while the efficacy has been stable, it’s been consistent.” She said the vaccine’s efficacy increased from about 74 percent to 94 percent when a booster dose was given after two months, highlighting the vaccines’ “unique profile.”
Any waning efficacy seen in its single-dose vaccine is linked to the spread of variants, not a function of time, Johnson & Johnson officials said.
This data differs from what was presented by Pfizer and Moderna.
Moderna and Pfizer’s booster returned their vaccine’s efficacy to normal, while Johnson & Johnson’s booster increase its original dose efficacy to the level of the other brands of vaccines, according to STAT News’ Helen Branswell.
There will be two votes at this hearing.
The first vote will determine if the data support the safety and effectiveness of the Johnson & Johnson booster dose for adults 18 years of age and older two months after the primary vaccination dose.
The second vote is based on whether the committee voted yes or no to the first questions.
If they vote yes on the first question, the committee will next vote if extending the interval between the first dose and the booster to at least six months will result in “a more robust booster response.”
If they vote no on the first question, the committee will vote if the data support a booster shot given six months after the first shot.
Anyone over the age of 18, regardless of health status, can get a Johnson & Johnson, according to the voting questions.
This criterion differs from Pfizer and Moderna booster shots, which were approved for specific groups of people. These groups including those over 65, people 18 to 65 with medical conditions that increase their risk for severe COVID-19, and people who live or work in places that expose them to a higher risk of contracting COVID-19.
This pair of graphs shows the rate of cases and then the rate of deaths between unvaccinated and fully vaccinated people.
This pair of graphs shows the rate of cases and then the rate of deaths by vaccine status and vaccine brand.
This pair of graphs shows the rate of cases and then the rates of deaths by vaccination status and age group.
The plans were already confirmed but the date at which the new rules would come into effect was uncertain.
“As morbidity declines, we can ease [restrictions]. We are thinking of lifting more Green Pass restrictions,” Ash told Radio 103FM, appearing to confirm a Thursday report that said the government was planning to push for a significant easing of COVID-19 limits.
A total of 1,325 new cases were identified nationwide yesterday - down from more than 10,000 a day at the height of the Delta variant wave in August and September.
Idaho has faced weeks of high COVID caseloads and hospitalization rates, with over 1,000 cases each day since early September.
FULL STORY: Idaho Doctor Says ‘We’ve Lost the War’ and COVID Is ‘Here to Stay’ as Cases Remain High
Concerns were raised when people had tested positive on lateral flow tests - rapid tests used widely by British households - but had negative PCR results.
The error means potentially thousands of people infected with the virus were wrongly told to stop isolating and could have infected others.
Economists hoped more people would find work in September as schools reopened, lessening child care constraints, and enhanced unemployment aid ended across the U.S. However, employers added just 194,000 jobs last month - much lower than expected.
FULL STORY: 3 Million U.S. Workers Have Not Resumed Job Search After COVID Pandemic Layoffs
The CDC said 217,953,275 people have received at least one dose so far while 188,281,747 people have been fully vaccinated.
On Tuesday evening, President Clinton was admitted to [University of California Irvine] Medical Center to receive treatment for a non-Covid-related infection. He is on the mend, in good spirits, and is incredibly thankful to the doctors, nurses, and staff providing him with excellent care.
FULL STORY: Bill Clinton Hospitalized in California With Infection
The Biden administration said in May that it supported waiving the intellectual property rights for COVID vaccines to boost production of the shots and Tai confirmed work was being done behind the scenes, even if it didn’t appear to be “from the public vantage point”.
FULL STORY: U.S. Says It Supports Vaccine Production Waiver, But All WTO Member States Must Agree
Follow Newsweek’s liveblog throughout Friday for all the latest.
