When the US Centers for Disease Control and Prevention decides whether and how to adopt the adviser’s recommendations, it will offer advice on how people should consider the US Food and Drug Administration’s permission to use the mix and match approach, formally known as the heterologous approach.
While the advisers just voted to recommend both Moderna and Johnson & Johnson boosters, it will now be up to CDC Director Dr. Rochelle Walensky to accept or modify the committee’s recommendation.
Here’s a look at some of the language being considered by the CDC:
The same product that was used for the primary regimen should be used for the booster.
- If that is not available or another product is preferred, heterologous boosting with a single dose of any of the authorized Covid-19 vaccine boosters is acceptable.
Heterologous dosing may be considered for the booster dose only.
- All doses of the primary series and additional dose (if indicated for moderately to severely immunocompromised people who received 2 doses of mRNA vaccine) should utilize the same vaccine product.
Individual benefit-risk assessment may inform which booster product to use.
- Availability of booster product
- Risk profile of vaccine boosters, including rare events
Vaccine advisers to the US Centers for Disease Control and Prevention voted on Thursday to recommend booster doses of Johnson & Johnson Covid-19 vaccines.
The vote came moments after they voted to recommend booster doses of the Moderna vaccine.
The CDC’s Advisory Committee for Immunization Practices accepted the US Food and Drug Administration emergency use authorizations for each vaccine – after considerable discussion about whether such broad authorization was needed for Moderna’s. Members broadly agreed that people who got Johnson & Johnson’s vaccine need a second vaccination, as that vaccine is less effective than Moderna’s and Pfizer’s in preventing infection.
What happens next: It will now be up to CDC Director Dr. Rochelle Walensky to accept or modify the committee’s recommendation. The CDC will also issue detailed clinical guidance spelling out what people should consider in seeking out and getting booster shots. This will include whether people may mix and match vaccines.
The FDA gave emergency use authorization Wednesday for booster doses of Moderna’s and Johnson & Johnson’s Janssen vaccines. The FDA also authorized a mix and match approach – saying people could get any vaccine as a booster, regardless of which vaccine they got for the initial immunization.
The FDA’S EUA covers Moderna recipients who were vaccinated at least six months ago or longer, who are 65 or older or who are 18 or older and at high risk of severe coronavirus infection because of a medical condition or because of working or living conditions – medical staff, for instance. That’s the same as the existing EUA for Pfizer’s vaccine. The EUA for the Janssen vaccine is for anyone who got that vaccine two months ago or longer.
ACIP modified its interim recommendation to use the same language to cover Moderna’s and Pfizer’s vaccines jointly.
Vaccine advisers to the US Centers for Disease Control and Prevention voted on Thursday to recommend booster doses of Moderna’s Covid-19 vaccine.
The CDC’s Advisory Committee for Immunization Practices accepted the US Food and Drug Administration emergency use authorization for a half dose of Moderna’s vaccine, combining it with the earlier recommendation for Pfizer’s vaccine.
The voting language said: “A single Covid-19 vaccine booster dose is recommended six months or more after completion of an mRNA primary series in the same risk groups for whom CDC recommended a booster dose of Pfizer-BioNTech, under FDA’s Emergency Use Authorization.”
Now they’ll vote on Johnson & Johnson’s vaccine.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is preparing to vote on whether to recommend booster shots for Moderna and Johnson & Johnson vaccines.
There will be two separate votes – one for Moderna and one for Johnson & Johnson.
Yesterday, the US FDA authorized booster doses of both Covid-19 vaccines and said any of the three authorized vaccines could be used as a booster in a mix-and-match approach.
After the advisers vote, CDC director Dr. Rochelle Walensky will need to sign off. If she does, people could start getting Moderna and J&J boosters within days.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will soon vote on whether to recommend the mix-and-match approach to booster vaccines authorized by the US Food and Drug Administration Wednesday.
They are also expected to vote on whether boosters of the Moderna and Johnson & Johnson vaccines are safe.
If the committee recommends them, the CDC director must give a stamp of approval for boosters doses to be officially administered.
Booster doses of coronavirus vaccines so far seem to be as safe as first and second doses, vaccine advisers to the US Centers for Disease Control and Prevention were told Thursday.
The Advisory Committee for Immunization Practices is meeting to decide whether to recommend the mix-and-match approach to booster vaccines authorized by the US Food and Drug Administration Wednesday. One question is whether adding a third dose of Moderna’s vaccine or a second dose of Johnson & Johnson’s is safe.
So far, the answer is yes, Anne Hause of the CDC’s Covid-19 Vaccine Task Force told the ACIP meeting.
She reviewed data from two vaccine safety monitoring programs – the Vaccine Adverse Reporting System (VAERS) and the cellphone-based vSafe system set up to monitor Covid-19 vaccines.
“Overall, 94% of the 4,990 adverse reports following dose two of Janssen or dose three of mRNA Covid-19 vaccinations were non-serious,” Hause said. She said rates are similar to what’s been seen for Covid vaccines in general. The most common serious adverse event was the wrong vaccine having been administered.
“Anyone can submit a VAERS report regardless of the possibility of vaccine causing the event or the clinical seriousness of the events,” Hause noted.
Nonetheless, few worrying reports came in.
“We did not observe any unexpected patterns of adverse events,” Hause told the meeting. “Nearly all reports to VAERS were non-serious.” Common adverse events included sore arms, headaches, fevers and muscle aches. A sore arm was considered a local event, while a fever or headache would be a systemic event.
“For Pfizer/BioNTech, local and systemic reactions were reported less frequently following dose three than dose two. For Moderna, local reactions were reported slightly more frequently and systemic reactions slightly less frequently following dose three than dose two,” she said.
Not many people have received a second dose of Johnson & Johnson’s Janssen Covid-19 vaccine, Dr. Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University who heads one of ACIP’s safety working groups, told the meeting. The vaccine is linked with a slightly higher risk of two rare but dangerous side effects – a blood clotting condition called thrombosis with thrombocytopenia syndrome, and a neurological condition called Guillain-Barré syndrome. “There have been no new safety signals following a second dose,” Talbot told the meeting.
The authorization process for Covid-19 vaccines can get confusing. Here’s a look at where we stand on Covid-19 boosters in the US today:
In September, the US Food and Drug Administration and US Centers and Disease Control and Prevention signed off on boosters of the Pfizer/BioNTech Covid-19 vaccine for adults 65 and older, adults at high risk of severe Covid-19 and adults with frequent exposure to the coronavirus through their work. Those boosters were authorized only for people who had already received the Pfizer vaccine at least six months earlier.
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, CDC’s vaccine advisers are considering whether to recommend such mixing and matching, and the CDC director will need to sign off on the recommendation. If she does, the mixing and matching of boosters could be available to the public in a matter of days.
Also today, Pfizer and BioNTech announced that a booster dose was found to have a high efficacy — 95.6% — against Covid-19 in a Phase 3 trial.
The FDA gave emergency use authorization on Wednesday 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.
Now vaccine advisers to the US Centers for Disease Control and Prevention are considering the FDA’s authorization and will vote on whether to recommend the booster for use.
Johnson & Johnson
On Wednesday, the FDA authorized booster doses of Johnson & Johnson’s vaccine for anyone who received It at least two months ago. The J&J vaccine authorized only for those 18 and older.
The company announced last month that a two-dose version of the vaccine provides 94% protection against symptomatic infection.
If the CDC director signs off soon, people could start getting Moderna and J&J boosters within days.
Mixing and matching boosters
The FDA said any of the three authorized vaccines could be used as a booster in a “mix-and-match” approach.
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.
The FDA said it decided to allow the mix-and-match boosters after National Institutes of Health researchers presented their findings last week to its vaccine advisers. Although the findings were limited, they made it clear mixing up the different vaccines was safe.
If the CDC director signs off soon, people could start getting Moderna and J&J boosters within days.
Europe was the only region in the world to report an increase in new Covid-19 cases, as global numbers stabilize or decline, the World Health Organization (WHO) said in its epidemiological update Wednesday.
The WHO said there were more than 2.7 million new coronavirus and 46,000 deaths globally in the week ending Oct. 19, representing a 4% and 2% drop, respectively. It described the figures as representing a “stabilization.”
Europe was the only exception, after it reported a rise in cases for the third consecutive week, amounting to a 7% increase in cases compared with the previous week.
The African region, by contrast, experienced the most significant decline in cases, after reported infections fell by 18%.
In a statement Thursday, WHO Europe cited uneven vaccine coverage as the “biggest enemy” facing the continent, after announcing that 1 billion Covid-19 vaccine doses have now been administered across the region.
“Uneven vaccine uptake in Europe is our region’s biggest enemy in the fight against COVID-19. A billion doses administered has led to roughly a third of the region being vaccinated. But huge disparities persist, with some countries struggling with inadequate vaccine supply, difficulties in reaching the most vulnerable, vaccine uptake and hesitancy,” the statement said.
These are some of the countries reporting record high Covid-19 cases:
- UK: New coronavirus cases are up 17% week over week, and deaths are up 21%, according to figures released on Wednesday. The UK on Thursday reported 52,009 new cases of Covid-19 after Health Secretary Sajid Javid warned on Wednesday numbers could reach 100,000 infections per day this winter. Despite this, the UK will not reinstate measures in England such as mandatory face coverings, prompting the British Medical Association (BMA) to accuse the government of being “willfully negligent”.
- Ukraine: Ukraine reported its highest daily number of Covid-19 cases since the beginning of the pandemic on Thursday, according to the data on the country’s coronavirus situation portal, with 22,415 cases in the last 24 hours. The country also recorded 546 deaths in the last 24 hours due to Covid-19, its highest number since the begging of the pandemic.
- Russia: Coronavirus infection rates have been surging across the country with daily infection numbers recently lingering around all-time highs too. As of Tuesday, Russia recorded 7,832,964 infections since the start of the pandemic and government officials have blamed increasing infections on low vaccination rates. Russia has lagged behind much of the world when it comes to getting its population inoculated, despite being the first country in the world to approve a coronavirus vaccine, Sputnik V, for use in Aug. 2020.
- Singapore: Singapore will extend its Covid-19 restrictions for another month after the city-state reported 18 new deaths from the disease on Wednesday, its highest number of the pandemic. In a news release Thursday, Singapore’s Ministry of Health said current measures would be extended to Nov. 21 to help contain case numbers, which rose by more than 3,800 on Wednesday.
- Caribbean: The Dominican Republic and Barbados are reporting a more than 40% increase in new cases over the past week. In Latin America and the Caribbean, 41% of people have been fully vaccinated against Covid-19 according to Pan American Health Organization (PAHO) Director Carissa Etienne at PAHO’s weekly press briefing on Wednesday. Yet, coverage has still not been evenly distributed across the region, Etienne said, imploring that public health measures be maintained and prioritized.
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.