FDA scientists strike favorable tone forward of vote this week

The Janssen Johnson & Johnson COVID-19 vaccine.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration staff adopted a more favorable tone on Wednesday Johnson & Johnson Covid-19 booster vaccination, which states that giving a second dose two months after the first vaccination may be beneficial.

However, staff admitted that data to support boosters was limited and the agency has not yet verified all of the information.

“Although not independently confirmed by the FDA from independent datasets, summaries of the data suggest that a second dose administered approximately 2 months after the primary dose may have a benefit compared to efficacy in the pivotal study COV3001,” they wrote in a 54-page document published on Wednesday.

They also said that a J&J dose was consistently less effective than the Pfizer and Moderna mRNA vaccines in both clinical trials and real-world trials.

“The highest effectiveness estimates (including for more severe COVID-19 illnesses) in clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine are consistently below the highest effectiveness estimates for the mRNA COVID-19 vaccines,” they said.

Overall, the data shows that the J&J single-shot vaccine “still offers protection from severe COVID-19 illness and death in the United States”.

The report by FDA scientists is set to brief the agency’s Advisory Committee on Vaccines and Related Biological Products, which will meet on Friday to discuss data on the safety and effectiveness of a second J&J syringe in adults. The published documents give an insight into the agency’s perspective on additional recordings.

Unlike Pfizer and Moderna’s two-step mRNA vaccines, J&J hoped to offer a one-shot solution that would protect the public adequately to contribute to the Coronavirus pandemic. But its 72% protection in the US was viewed by some as inferior to the Moderna and Pfizer vaccines, both of which touted efficacy rates of over 90%.

A second dose of J & J’s Shot provides similar performance to the mRNA vaccines and increases protection against symptomatic infection to 94% when given two months after the first dose in the United States, according to company data released Sept. 21 became. J&J, the a. used modified adenovirus In order to trigger an immune response, the agency asked on October 5 for approval of a booster dose of its single-dose vaccine for people aged 18 and over.

However, in the documents released on Wednesday, FDA scientists suggested that there wasn’t enough data on the elderly or the fast-paced Delta variant to draw any conclusion about the benefits of boosters.

They said the sample size J&J provided for people 60 years and older “limits the possibility of inferring an increase in efficacy after the second dose in this group.”

“Finally, the small number of defendants who have been confirmed to be caused by the Delta variant precludes any conclusion as to effectiveness against the variant,” they added.

Staff said no new safety issues were observed after a second dose given two or three months after the first dose, but noted that it is currently unknown “if after” an increased risk of these or other side effects there is an additional dose.

The FDA advisory group is due to discuss data on the safety and effectiveness of booster vaccinations for Moderna in adults on Thursday and J&J on Friday. The agency could make a final decision within days of the meetings and hand it over to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee, expected to make their own decision next week.

FDA scientist refused to take a stand whether on Tuesday, in an unusual move, booster shots of the Covid vaccine from Moderna will be supported, with the data showing that currently approved vaccines in the US still protect against serious illness and death

Last month, US regulators authorized Covid booster recordings from Pfizer and BioNTechs Vaccine for a wide variety of Americans, including the elderly, adults with pre-existing conditions, and those who work or live in high-risk environments such as health and food workers.

Norman Baylor, former director of the FDA’s vaccines office, said last week that he did not recommend presenting Moderna’s vaccine to an advisory committee because it uses a similar platform to Pfizer’s vaccination, which has already been approved for booster vaccination. J&J is different, however.

It “gets a little trickier” because a second dose of J & J’s vaccine appears to work “extremely well,” Baylor said. “Maybe it should have been a two-dose [vaccine] at the beginning.”

CDC masks pointers might enhance danger of spreading Covid at work and in public, scientists say

The CDC’s new mask guidelines could actually increase the risk of Covid-19 spreading in public spaces and workplaces, scientists from a leading group of infectious diseases said Thursday.

The Centers for Disease Control and Prevention abruptly reversed Mask instructions for vaccinated Americans last week said vaccinated people no longer need to wear a mask indoors or outdoors in most environments. Officials said they changed their guidelines in part because research shows the vaccines offer very high levels of protection against the disease of Covid-19 and spread it to others.

“There is no debate about this fact,” said Dr. Jeffrey Duchin, who sits on the CDC’s Advisory Committee on Immunization Practices, at a news conference hosted Thursday by the Infectious Diseases Society of America. However, the agency’s announcement created widespread confusion and frustration because “it was unexpected and lacked the necessary context for implementation by the state and local health community,” he said.

Duchin is the society’s liaison with the CDC’s Vaccination Committee. The company represents leading specialists in infectious diseases in the USA

“There was no information on how the guidelines could be used in practice, particularly in relation to the inability to check vaccination status,” said Duchin. The CDC also did not provide guidance on whether people should continue to wear masks in areas with high transmission rates or low vaccination rates, he said. “What the CDC did, however, was not optimal and gave the wrong impression that the mask mandates were being lifted.”

Doctors across the country and federal health officials continue to stress that only vaccinated people are safe to remove their masks. The new mask management was misinterpreted as the end of the pandemic and mask mandates, which puts the local health authorities in a very difficult position. States in the United States took the news as a cue to facilitate mask mandates. Texas Governor Greg Abbott used the new guidance to justify signing an executive order that threatens the fine for local officials and communities for not dropping mask requirements.

Duchin said that both vaccinated and unvaccinated people are likely safe outdoors without masks, but they are not indoors.

“Now the risk of Covid-19 spreading in crowded indoor spaces with unvaccinated people and especially with poor ventilation is increased,” said Duchin. While the CDC’s scientific basis for the change is “solid,” Duchin said ending the mandate for inner masks “could lead to increased risk in public spaces and workplaces with avoidable spread of Covid-19, mostly among the unvaccinated spreads. “

Vaccination rates vary across the country, and the majority of those vaccinated are older adults. Large subgroups such as younger adults remain unvaccinated.

Dr. Jeanne Marrazzo, who also spoke at the briefing, said research has shown that up to 3% of Americans have been told by their doctors that they have some level of immunodeficiency, which puts them at an increased risk of being exposed to Covid be.

“Millions of people fit that bill, and we literally have very little data on whether the vaccine works in them,” Marrazzo said. “There is a real reason to be careful and interpret the guidelines carefully.”

The scientists also said people need to acknowledge that there is uncertainty about the future course of the pandemic, the effects of emerging variants, the duration of immunity, and the potential for a Covid-19 resurgence.

“The Covid-19 outbreak is by no means over, there is still significant uncertainty and there is still significant disease activity,” said Duchin.

If someone is fully vaccinated and doesn’t have other conditions that threaten their community, and if the rate of Covid where they live is relatively low and the vaccination rate is high, Marrazzo said it would be “100% okay, pretty much anywhere without one. ” Mask.”

Marrazzo added that despite being fully vaccinated, she will continue to wear a mask around the house as vaccination rates in her community are not even 50%.

“If I knew we were seeing really notable decreases in hospital stays and symptomatic illnesses that may be related to Covid and that have a very high vaccination rate, I would probably go without a mask, but I won’t see this anytime soon,” she said.

While nearly half of all people in the United States, 160.2 million, received at least one shot, Marrazzo said only 4.6% of the world’s population did the same.

“People need to be aware of what’s going on and watch out for vaccination rates, look for the involvement of these new varieties and think about being ready to get things going again,” warned Marrazzo.

Correction: This story has been updated to reflect that the press conference was hosted by the Infectious Diseases Society of America.