In documents released Tuesday, Moderna argued that the Food and Drug Administration should authorize a half-dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence that the vaccine’s potency against infection wanes over time. The agency noted in its own analysis that, overall, available data show that Moderna and the other vaccines “still afford protection against severe COVID-19 disease and death in the United States.”
Moderna cited the rate of breakthrough infections, “real world evidence of reduced effectiveness against the delta variant,” and falling levels of neutralizing antibodies from its vaccine six to eight months after a second dose. The company said its clinical trial studies showed that a third injection boosted antibody levels — one measure of the immune system’s response — higher than what they had been before the second dose.
The documents were released by the FDA before a two-day meeting of the agency’s advisory committee, scheduled for Thursday and Friday. In its own briefing document for the committee, also released Tuesday, the FDA summarized the data without taking a position.
The committee is expected to vote on whether to recommend emergency authorization of boosters of Moderna’s and Johnson & Johnson’s vaccines. While the panel’s votes are not binding, regulators typically follow them.
Moderna did not try to argue that its vaccine is waning now against severe disease or hospitalization, and the existing data do not appear to support that claim. That distinguishes Moderna’s application from Pfizer-BioNTech’s last month.
In its document, the FDA said, “Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 vaccine over time against symptomatic infection or against the delta variant, while others have not.”
The agency said “there are many potentially relevant studies,” and it has not independently reviewed the underlying data or conclusions of each one.
The FDA and the Centers for Disease Control and Prevention decided to authorize boosters for many but not all Pfizer-BioNTech vaccine recipients. The eligible include those who are 65 or older, who live in long-term care facilities, who have underlying medical conditions or who are at higher risk of exposure to the virus because of their jobs or institutional settings. The last group includes health care workers, teachers, and prisoners.
In the document released Tuesday, the FDA proposed the outside experts consider essentially the same eligibility groups for Moderna recipients. But people familiar with the deliberations said that federal officials may also ask the committee to consider broadening eligibility for boosters of both vaccines to include more middle-aged people.
Moderna said it compared using a full dose and a half-dose as a booster and found that a half-dose boosted antibody levels well with lower risks of adverse side effects. It also tried to make a point about conserving limited supplies, saying a half-dose “would result in a substantial increase in the world wide supply” of its vaccine.
NEW YORK TIMES
Airlines to follow Biden COVID mandate, defying Texas order
American Airlines Group Inc., the biggest US airline, and number 4 Southwest Airlines Co. will follow President Biden’s mandate requiring that employees be vaccinated against COVID-19, defying an order from the Texas governor blocking such actions.
The decisions Tuesday set up an immediate challenge to Republican Governor Greg Abbott by two of the state’s largest corporations. Companies with business operations in Texas like the two airlines have been caught between Abbott’s decree and a White House measure that says federal contractors must require the shots.
American employed 117,400 workers nationwide as of the end of June and Southwest had about 54,500 staff. Both airlines have contracts with the federal government for transporting employees and goods.
“We believe the federal vaccine mandate supersedes any conflicting state laws, and this does not change anything for American,” Fort Worth, Texas-based American said of the state’s ban.
Dallas-based Southwest echoed that statement.
“We would be expected to comply with the president’s order to remain compliant as a federal contractor,” the company said.
Late Tuesday, International Business Machines Corp. also said it will follow the vaccine mandate.
Florida fines county over employee firings
TALLAHASSEE, Fla. — Florida has issued its first fine to a county it says violated a new state law banning coronavirus vaccine mandates and for firing 14 workers who failed to get the shots.
The Florida Department of Health on Tuesday issued the $3.5 million fine for Leon County, home to the state capital, saying the municipality violated Florida’s “vaccine passport’' law, which prohibits businesses and governments from requiring people to show proof of COVID-19 vaccination.
“These are people that, presumably, have been serving throughout this whole time and now all of a sudden they’re basically getting kicked to the curb,” Florida Governor Ron DeSantis said at a news conference in St. Pete Beach.
Later, the governor tweeted, “No one should lose their jobs because of COVID shots.’’
The law took effect last month and can result in a $5,000 fine per violation. It is being challenged in court and conflicts with a Biden administration order that companies with more than 100 employees require their workers to be vaccinated or face weekly testing.
In a statement, Leon County administrator Vincent Long said the county believes its vaccination requirement is legally justifiable and necessary to keep people safe.
“The governor’s position in this instance unfortunately appears to be less of a public health strategy and more about political strategy,” he said.
Over 700 apply for refreshed WHO virus inquiry panel
The position is unpaid. The world’s scientists and Internet sleuths will scrutinize every move. Completing the first assignment with the available tools, and to everyone’s satisfaction, will be nearly impossible.
Despite those considerable obstacles, more than 700 people have applied for spots on a new committee charged with breathing life into the World Health Organization’s stalled inquiry into the origins of the coronavirus pandemic.
The committee, expected to be announced this week, represents an attempt by the embattled global health body to reset its approach to determining how the pandemic began. Nine months after sending a team of international experts to China, only for its findings to become entangled in geopolitics and trailed by concerns over Beijing’s influence, the WHO is trying to inoculate its latest efforts from the slightest hints of undue deference toward China.
Its new advisory team will include specialists in fields like laboratory safety and biosecurity, a step that analysts say may help placate Western governments pressing for consideration of whether the virus emerged from a lab. And, crucially, the committee will have a mandate to weigh in on the emergence of any new pathogens beyond this novel coronavirus, giving it a permanence that could help insulate it from political squabbling and strengthen the WHO’s hand for future outbreaks.
Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said the group — comprising some two dozen virologists, geneticists, animal experts, and safety and security specialists — would help the organization return to its roots amid the rancor and partisanship of the coronavirus origins debate.
“Especially in light of the politicization of this particular aspect,” she said, “we want to take this back to the science, take this back to our mandate as an organization to bring together the world’s best minds to outline what needs to be done.”
NEW YORK TIMES
Puerto Rico’s governor to lift alcohol sales ban
Puerto Rico’s governor said Tuesday he would be lifting a curfew and a ban on alcohol sales as the US territory reports a drop in the number of COVID-19 hospitalizations and deaths.
Current restrictions prohibit certain businesses from operating between midnight and 5 a.m. and also bar alcohol sales during that time, two measures that will be lifted Thursday.
However, Governor Pedro Pierluisi said other restrictions, including an indoors mask requirement, remain in place.