CDC advisers will meet soon to consider Moderna and J&J Covid boosters
NOW: CDC vaccine advisers’ meeting begins
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet from 10 a.m. ET to 5 p.m. ET today.
A vote is scheduled for later this afternoon.
ACIP is expected to vote on whether to recommend use of the boosters. If the committee recommends them, the CDC director must give a stamp of approval for boosters doses to be officially administered.
Today’s meeting includes presentations on booster data for the Moderna and Johnson & Johnson vaccines and mix-and-match boosters; safety of third doses, as well as data around myocarditis; Covid-19 primary series effectiveness, evidence for a recommendation and clinical considerations. The full meeting agenda is listed here.
Remember: On Wednesday, the US Food and Drug Administration authorized booster doses of Covid-19 vaccines made by Moderna and Johnson & Johnson and also said any of the three authorized vaccines could be used as a booster in a mix-and-match approach.
Pfizer’s Covid-19 booster shows 95.6% efficacy in Phase 3 trial, company says
From CNN’s Jacqueline Howard
A booster dose of the Pfizer/BioNTech coronavirus vaccine was found to have a high efficacy – 95.6% – against Covid-19 in a Phase 3 trial, the companies announced on Thursday.
They noted that “efficacy was consistent irrespective of age, sex, race, ethnicity or comorbid conditions.”
The trial included more than 10,000 fully vaccinated people, age 16 and older, who randomly received either the 30-microgram booster dose of vaccine or a placebo. The median time between completing their initial second dose of vaccine and receiving a booster or placebo was about 11 months, the companies said.
Pfizer and BioNTech reported that during the study, there were 109 Covid-19 cases among people who received a placebo and five cases among those who received the third dose of vaccine. The companies noted that the vaccine efficacy they found, of 95.6%, reflects that reduction of disease among those who received a booster shot versus those who did not. These are the first results from a randomized, controlled Covid-19 vaccine booster trial, the companies said, and they reflect a period when the highly contagious Delta variant was prevalent.
“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a news release Thursday.
“In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic,” Bourla said. “We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.”
In September, the US Food and Drug Administration authorized a booster dose of the Pfizer/BioNtech coronavirus vaccine for emergency use in adults 65 and older, adults at high risk of severe Covid-19 and adults with frequent exposure to the coronavirus through their work.
Then on Wednesday, the FDA authorized the Pfizer/BioNTech booster for those who may be eligible but are fully vaccinated with either the Moderna or Johnson & Johnson coronavirus vaccines, as a mix-and-match approach.
Today, the US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, meet to decide on whether to recommend the FDA’s recent mix-and-match authorization – as well as the authorization of Moderna and J&J boosters – and then the CDC director will decide whether to sign off on ACIP’s guidance
Fauci says CDC will make clear recommendations on boosters
From CNN’s Naomi Thomas
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on CBS on Thursday the US Centers for Disease Control and Prevention will come out with clear recommendations about what people who have had Covid-19 vaccines can do when it comes to boosters.
“I think now with the announcement that was just made from the FDA and the recommendations that will almost certainly come imminently, very soon certainly from the CDC, that things will really be very clear of what people can and should do,” Fauci said, when asked if there is a better way for experts to get the messaging out about vaccines and boosters so that people aren’t distrustful or hesitant.
Fauci acknowledged that when there are three vaccines with different characteristics, “there can be confusion, but I think right now things are going to be pretty clear when people hear what is available to them.”
“The mix and match really gives a good deal of flexibility to people in whatever it is that they want to choose,” he said. “And the CDC, I am sure, will come out with some pretty clear recommendations depending upon what category you fit into.”
People who are eligible for boosters and want optimal protection should get them, Fauci says
From CNN’s Naomi Thomas
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on CBS on Thursday that while the Covid-19 vaccines are still working well against severe disease, people who want optimal protection and are eligible for a booster should get one.
“The vaccines from the original regimen that we got still holding really quite well when it comes to protection against severe disease and hospitalization,” Fauci said, when asked how safe people who have been vaccinated but haven’t got a booster yet should feel. Fauci added that experience from both the United States and Israel shows that the protection does wane after a period of time.
“Even though people right now who’ve been vaccinated within the last several months can feel comfortable, if you really want to have the optimal protection, Gayle, then the people who are qualified and eligible to get the booster should do it,” Fauci told Gayle King.
“The good news,” he said, “is that now everything is a level playing field, those who got J&J, those who got Moderna and those who’ve gotten Pfizer, there’s availability now to get boosters for all of those people who are in those three separate groups.”
The US Food and Drug Administration authorized Moderna and Johnson & Johnson boosters for some adults yesterday, as well as mixing and matching of boosters. Today, the US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, meet to decide on whether to recommend the FDA’s recent mix-and-match authorization — as well as the authorization of Moderna and J&J boosters — and then the CDC director will decide whether to sign off on ACIP’s guidance. At that point, shots can be administered.
Asked if he would get a J&J booster if he had initially got a J&J shot, Fauci said it depends on individual preference, consulting with your physician, and considerations like age and gender.
“The risks for adverse events, Gayle, are really very, very rare and very, very low,” he told King. “But in a certain situation, for example, if I were a woman, I would probably not have any problem at all with an mRNA because the rare, rare adverse event with the mRNA is almost exclusively seen in young men. So, you really have to balance what the risk benefit is. But, I want to emphasize that the risk of adverse events is really very, very low.”
FDA authorized booster doses of Moderna and Johnson & Johnson vaccines. Now it’s up to the CDC.
From CNN’s Maggie Fox
The US Food and Drug Administration authorized booster doses of Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster in a mix-and-match approach.
But it left in place a complex formula for who should get get boosters and when, with officials saying they may simplify the framework as more safety data comes in.
Now vaccine advisers to the US Centers for Disease Control and Prevention will consider the FDA’s authorization, and offer their own advice. If CDC director Dr. Rochelle Walensky signs off, people could start getting Moderna and J&J boosters within days.
The FDA gave emergency use authorization for a half dose of Moderna’s vaccine as a booster for people fully vaccinated at least six months ago who are also at least 65, or who are at least 18 and at high risk of severe Covid-19 or have frequent institutional or occupational exposure to the virus.
It also authorized booster doses of Johnson & Johnson’s vaccine for anyone who got that vaccine, so those 18 and older, at least two months ago.
And it said any of the three authorized vaccines could be used to boost. Pfizer already has authorization for booster shots for its vaccine for people vaccinated at least six months ago – with the same restrictions as those for Moderna’s vaccine: those 65 and older and those with a higher risk of severe disease.
“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
Dr. Peter Marks, director of the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said the ability to use any authorized vaccine as a booster will simplify matters for people.
“Being able to interchange these vaccines is a good thing. It’s like what we do with flu vaccines. Most people don’t know what brand flu vaccine they received,” Marks told reporters in a telephone briefing.
Marks said the FDA would consider lowering the age ranges for booster shots as more safety data comes in.
“We want to make sure that if we deploy the boosters in all of the age ranges, that we truly are making a benefit outweigh any risks,” Marks said. “We will not hesitate to drop this age range as we see this benefit outweigh the risk, and because of the EUA authority that we have, we can do that in a relatively quick amount of time.”
Read the full article here.
The toll of Covid-19 on children is “quite significant,” US surgeon general says
From CNN’s Naomi Thomas
US Surgeon General Dr. Vivek Murthy told CNN that the coronavirus pandemic has had a “quite significant” toll on children.
“Yes, sadly, there have been hundreds of children who have died, thousands and thousands who have been hospitalized, particularly during the Delta surge, but we’ve also seen other consequences,” Murthy told CNN’s John Berman Thursday.
“We’ve seen long Covid among children…we’ve seen things like myocarditis and other complications that have arisen from Covid infection. And think about the lives that our kids have had to go through those last 18 months, many have not been in school consistently, they’ve had to be quarantined, they’ve missed out on social engagements and get togethers, youth sports have been disrupted. When you look at the toll, the price tag if you will, of Covid on our children it is quite significant.”
Asked on how parents can be convinced that the vaccine is necessary for their children, Murthy told Berman, “It’s important to look at the whole picture … like when you look at how our children and their lives have been impacted by Covid-19, it falls into several buckets.”
On whether children getting Covid-19 vaccines would impact the need to wear masks at all, Murthy said, “I think down the line it very well may, depending on, again, what happens with cases, we’ve got to get cases to come down and stay down.”
“While we still have such high levels of infection in the community … it’s likely the CDC will continue to recommend the wearing of masks for vaccinated and unvaccinated individuals indoors,” he said.
CDC advisers will meet today to consider 2 Covid-19 boosters, a day after the FDA authorized them
From CNN’s John Bonifield and Maggie Fox
The US Food and Drug Administration authorized booster doses of both Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster in a mix-and-match approach.
The FDA gave emergency use authorization for boosters of Moderna’s vaccine for people fully vaccinated at least six months ago who are also at least 65, or who are at least 18 and who are high risk of severe Covid-19 or have frequent institutional or occupational exposure to Covid-19.
“The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older,” the FDA added in a statement.
“The use of each of the available COVID-19 vaccines as a heterologous (or ‘mix and match’) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine,” the FDA said.
“To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2,” it added.
The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, will meet today to decide on whether to recommend the FDA’s authorization for the Americans people, and then the CDC director will decide whether to sign off on ACIP’s guidance.
Source: http://rss.cnn.com/~r/rss/cnn_topstories/~3/LcTPCDh5L0E/index.html
