The latest on Covid-19 vaccine boosters in the US

Following the rollout of a third dose of Covid-19 vaccine in Israel, severe Covid-19 cases among vaccinated people decreased sharply and confirmed infections fell overall, Israeli health officials said on Thursday.

In a meeting, Dr. Sharon Alroy-Preis of Israel’s Ministry of Health and Ron Milo of the Weizmann Institute in Israel presented data on the use of Covid-19 booster doses in their country to the US Food and Drug Administration Vaccines and Related Biological Products Advisory Committee.

As the nation began to offer booster doses to more age groups, the percentage of positive Covid-19 tests dropped to 2.6%, and the overall incidence of severe cases declined.

“We have improved protection against confirmed infection for all ages 16 and above. We have improved protection against severe disease in ages 40 and above,” Alroy-Preis said. “It could impact even younger than 40 years old for severe and critical disease and mortality.”

A member of the U.S. Armed Forces administers a COVID-19 vaccine at a FEMA community vaccination center on March 2, 2021 in Philadelphia, Pennsylvania.

Only about a quarter of Covid-19 vaccinations administered each day are first doses, according to data published Wednesday by the US Centers for Disease Control and Prevention.

Here’s latest data on vaccination efforts in the US:

Covid-19 still poses a great threat to more than 65 million eligible people who remain unvaccinated. CNN’s Dr. Sanjay Gupta spoke to vaccine skeptic Joe Rogan for more than three hours about some of his concerns around vaccines.

You can listen to Dr. Sanjay Gupta and Joe Rogan’s conversation on vaccines here.

Data suggests side effects from a booster dose of a mRNA Covid-19 vaccine have been similar in frequency and type to those seen after second doses — and were “mostly mild or moderate and short-lived,” US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said on Sept. 28.

The two-shot vaccines from Moderna and Pfizer both use genetic material called messenger RNA, or mRNA, to deliver immunity.

Walensky cited a study published that day by the CDC. It covers 22,191 people who received a third dose of an mRNA vaccine and made reports to CDC’s v-safe system, a voluntary, smartphone-based app that lets people report how they feel after they’ve been vaccinated. The reports were made from Aug.12 (when the US Food and Drug Administration OK’d additional doses for certain immunocompromised people) through Sept. 19.

Among those 22,191 who made reports, about 7,000 – nearly 32% – reported any health impacts. More than 6,200 – about 28% – reported they were unable to perform normal daily activities, mostly commonly on the day after vaccination.

The most common complaints were injection site pain (71%), fatigue (56%) and a headache (43.4%). Of those who reported general pain, only about 7% described it as “severe.” Severe was defined as pain that makes “daily activities difficult or impossible.”

Nearly 2% said they sought medical care and 13 people were hospitalized, but it was not clear from the v-safe reports why these people sought medical care or were hospitalized. Those who sought medical attention are contacted by staff members from the Vaccine Adverse Event Reporting System and encouraged to make a report, it said.

Of the 22,191 people, 12,591 happened to have tracked how they felt after all three doses. Out of that smaller group, 79.4% reported a local reaction to the third shot and 74.1% reported a systemic reaction. That’s similar to what they reported after a second dose, when 77.6% reported local reactions and 76.5% reported systemic reactions.

No unexpected patterns of adverse reactions were identified, the report said.

Some people reported getting a booster from different company than their original vaccine or getting a second dose of the single-dose Johnson & Johnson vaccine, but the report’s authors said the numbers in both cases were too small to draw any conclusions.

President Biden is set to deliver remarks this morning about his administration’s Covid-19 response and the state of the pandemic.

He is expected to highlight progress on America’s vaccination program.

The official continued, “He will also highlight the ongoing work on boosters and ensuring our schools remain safe and open. Last, he will remind the American people that even with this strong progress, now is not the time to let up in our response.”

Covid-19 remains a key political priority, and Thursday’s remarks indicate Biden is working to restore confidence in his handling of it.

The White House yesterday touted “tremendous progress” for Covid-19 vaccinations as cases are trending downward across the country, outlining success in private sector efforts to mandate vaccines.

“More than 3,500 organizations, from healthcare systems, to educational institutions, to state and local governments, to private businesses have already stepped up to adopt vaccination requirements,” White House Covid-19 response coordinator Jeff Zients told reporters.

Those mandates, he said, “have increase vaccination rates by 20-plus percentage points, with organizations routinely seeing their share of fully vaccinated workers rise above 90%.”

As for boosters, Zients said it is “off to a very strong start,” with an estimated over 7 million Americans receiving a booster by the end of the day Wednesday, including approximately 3 million in the past week.

The US Food and Drug Administration’s vaccine advisers are scheduled to meet today to discuss boosters, including booster data for Moderna’s Covid-19 boosters. Zients said the administration is ready should that decision move forward on Moderna’s boosters or Johnson & Johnson’s.

Zients noted that since Biden announced vaccination requirements for the federal government, “The number of eligible Americans who are unvaccinated has decreased by about one-third, from 97 million down to 66 million individuals.”

Vaccines, Zients reiterated, are accelerating US economic recovery as Americans feel more comfortable traveling, dining out, and shopping.

“People want to work, shop, and visit where they feel safe,” he said.

CNN’s Kate Sullivan contributed reporting to this post.

A new study from the National Institutes of Health found it was safe for people to get a Covid-19 booster different from the vaccine they initially received and that they generated robust immune responses.

For those who initially got the single-shot Johnson & Johnson vaccine, a boost from the Pfizer or Moderna vaccine seemed to provide a stronger antibody response. People who initially got the Pfizer or Moderna shot seemed to have a comparable response with any booster. Among those evaluated early in the trial, the protection against the Delta and Beta variants “increased substantially” following the booster.

The study followed 458 people at clinical trial sites around the country. The results have not yet been peer-reviewed or published, but are expected to be discussed during a meeting of the US Food and Drug Administration’s vaccine advisers on Friday.

The boosters were tested in two age groups – people who were ages 18 to 55 and people who were age 56 and older. The groups weren’t large enough to compare their responses, the study said. All participants were observed for 30 minutes after receiving a shot. Researchers also collected blood to determine how much of an immune response the shot provided at days one, 15 and 29. People were also asked to record any side effects. 

The side effects were similar to what people experienced with the initial shot. Half of the study participants experienced some side effect including pain at the injection site, tiredness, nausea, chills, headache and muscle pain. Most symptoms were felt one to three days after the booster. None of the side effects were serious.

Both Moderna and Pfizer use mRNA technology – genetic material called messenger RNA delivered directly to cells to instruct the body to make little pieces of the virus to stimulate an immune response. The Janssen vaccine is a vector vaccine, which uses an adenovirus that’s crippled so it cannot replicate to carry pieces of the coronavirus to stimulate the response.

Vaccine advisers to the US Food and Drug Administration are meeting this morning to discuss whether to authorize boosters of Moderna’s coronavirus vaccine for some adults.

It’s the first portion of a two-day Vaccines and Related Biological Products Advisory Committee meeting that will also include a vote on boosters for the Johnson & Johnson vaccine and a presentation on mix-and-match vaccines.

Thursday’s agenda focuses on Moderna boosters, and includes a presentation by Moderna, and another by the FDA, which will provide its assessment of Moderna’s booster data.

Moderna is requesting authorization for a 50-microgram booster dose – half the size of the 100-microgram doses used in the primary series of the two-dose vaccine – at least six months after the second dose, and only for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe Covid-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for Covid-19 complications or severe illness 

Moderna’s request mirrors the groups authorized to receive a booster dose of Pfizer’s mRNA vaccine. Third doses of the Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.

On Thursday, the committee will hear from Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research who recently took over as acting director of the agency’s Office of Vaccines Research and Review as two of its senior leaders prepared to depart the agency.

Israeli researchers will also brief VRBPAC on booster data from there; most people in Israel received the Pfizer Covid-19, and boosters for vaccinated people began weeks before the United States authorized Pfizer boosters. The presenters, Dr. Sharon Alroy-Preiss, director of public health services at Israel’s Ministry of Health and Ron Milo, a professor at Israel’s Weizmann Institute, spoke in support of Pfizer’s booster application last month.

The meeting, which will be streamed online, is scheduled to last until 4:45 p.m. ET. A two-hour period for discussion and voting is scheduled to begin at 2:45 p.m. ET.

More on the process: The FDA’s committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine. If the FDA gives emergency use authorization to Moderna boosters, vaccine advisers to the US Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation.

The CDC’s Advisory Committee on Immunization Practices is already scheduled to meet to discuss boosters from 10 a.m. to 5 p.m. ET Oct. 20 to 21.

In documents released ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Moderna urged the agency to authorize a 50-microgram booster dose of its Covid-19 vaccine. 

That dose is half the size of the 100-microgram doses used in the primary series of the two-dose vaccine. The company says this booster dose increases protection against the coronavirus while helping to keep the worldwide Covid-19 vaccine supply higher.

The documents were released ahead of the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee this week that will consider booster doses of the Moderna and Johnson & Johnson Covid-19 vaccines. The FDA previously authorized boosters of Pfizer’s Covid-19 vaccine for some adults. 

Moderna is requesting authorization for a 50-microgram booster dose at least six months after the second dose for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe Covid-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for Covid-19 complications or severe illness.

Antibodies have been shown to wane several months after people complete their Moderna or Pfizer vaccine series, but protection against severe disease and death remain strong after two doses. However, Moderna says, trial data and real-world evidence “support interventions to restore or enhance” antibodies that have waned over time.

“Clinical trial data breakthrough infections as well as real world evidence of reduced effectiveness against the Delta variant indicate that a booster dose of mRNA-1273 for those vaccinated more than 6 months previously could be beneficial to restore antibody titers to higher than post-dose 2 levels and reduce the number of breakthrough cases particularly against (variants of concern),” Moderna said in its briefing document. 

Efficacy against symptomatic Covid-19 wasn’t evaluated among booster dose recipients, the FDA analysis notes.

Moderna’s authorization request includes results from a study of 171 people who received the authorized 100-microgram doses of Moderna’s vaccine and a 50-microgram booster dose at least six months later – a smaller group than the more than 300 who were studied ahead of Pfizer’s booster authorization request. It also included safety data from additional Moderna trial participants.

There was a higher rate of swollen lymph nodes after the booster dose when compared with the second dose in the primary series, but safety data didn’t otherwise show increased frequency or severity of reactions after a booster dose, the FDA’s analysis said. It notes that trials conducted before authorization might not be large enough to fully understand uncommon, potentially serious adverse reactions.

“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of the Moderna COVID-19 Vaccine,” the FDA’s analysis says. “These risks and associated uncertainties have to be considered when assessing benefit and risk.” The two-dose mRNA Covid-19 vaccines made by Moderna and Pfizer have been linked to rare cases of heart inflammation, particularly among younger men. Studies have found the cases are generally mild.

The US Food and Drug Administration’s independent vaccine advisers are expected today to discuss and vote on whether to recommend authorization of boosters for the Moderna Covid-19 vaccine.

On Friday, the advisers are scheduled to discuss and vote on whether to recommend authorization of boosters for Johnson & Johnson’s Covid-19 vaccine. Both vaccines are already authorized for use in people age 18 and older. Members of the Vaccines and Related Biological Products Advisory Committee will also hear a presentation on Friday on “mix and match” booster doses.

The committee of independent advisers typically discusses and makes recommendations to the FDA around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK vaccines.