Total Doses Distributed = 953,826,425. Total Doses Administered = 668,814,259. Number of People Receiving 1 or More Doses = 268,927,705. Number of People Fully Vaccinated = 229,619,755.
COVID-19 Vaccination Data Updates
WKMG News 6 & ClickOrlando
The U.S. is poised to make COVID-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus.
The Food and Drug Administration asked its scientific advisers Thursday to help lay the groundwork for switching to once-a-year boosters for most Americans — and how and when to periodically update the shots’ recipe.
“This is a consequential meeting to determine if we’ve reached the point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” said FDA’s Dr. David Kaslow.
The advisory panel mostly agreed with the FDA’s approach.
COVID-19 vaccines have saved millions of lives and booster doses continue to help the most vulnerable even as more contagious variants have popped up. But protection does wane and the shots don’t fend off milder infections for long.
And people are tired of getting vaccinated. While more than 80% of the U.S. population has had at least one COVID-19 shot, only 16% of those eligible for the latest boosters — so-called bivalent doses updated to better match more recent virus strains — have gotten one.
That makes for tough decisions on how to move forward: Who really needs another shot, how often and what kind?
“We’re still protected against severe disease, thank goodness,” even after the latest mutated omicron strains cropped up, noted FDA adviser Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.
The first step: The FDA advisory panel voted unanimously that people should get the same vaccine formula whether they’re receiving their initial vaccinations or a booster. Today, Americans get one formula based on the original coronavirus strain that emerged in 2020 for their first two or three doses — and their latest booster is a combination shot made by Pfizer or Moderna that adds omicron protection.
The FDA would have to decide how to phase in that change.
But “this isn’t only a convenience thing” to ease confusion about different kinds of shots, said Dr. Archana Chatterjee, dean of Chicago Medical School. Since the original coronavirus strain has disappeared, “moving towards the strains that are circulating is very important.”
Who needs another shot and when sparked more debate.
Looking ahead, the FDA said most Americans should do fine if they get a once-a-year booster targeted to the newest variants in the fall. The agency asked if some people might need two doses — adults with weakened immune systems and very young children who’ve never been previously vaccinated. That’s similar to how youngsters get their first-ever flu vaccination.
But more data is needed to show exactly who might need two yearly doses — such as a careful count of who still gets hospitalized with COVID-19 despite being up-to-date with today’s vaccinations, Offit said.
“Only then can we really best make the decision about who gets vaccinated with what and when,” he said.
Nor is it clear that younger, healthier people would need a COVID-19 booster every year.
“It’s hard to say it’s going to be annual at this point,” said Harvard’s Dr. Eric Rubin.
Fall might not even be the best time to boost, something that would depend on when infections start rising and how long a booster’s protection might last, said FDA adviser Dr. Arthur Reingold of the University of California, Berkeley.
Unlike flu which in the U.S. circulates mostly during late fall and winter, COVID-19 waves have occurred year-round.
As for the recipe, the FDA’s plan is to call its advisory panel for another meeting in late May or early June to decide if the vaccine recipe needs tweaking — including which virus strain to target and whether it should be a single-strain or multi-strain shot. Pfizer and Moderna said that would give enough time to produce needed doses by fall while a third manufacturer, Novavax, urged an earlier start to any recipe change.
Also Thursday, U.S. officials updated how they’re tracking that the newest COVID-19 boosters are safe. The Centers for Disease Control and Prevention spotted a possible warning signal that seniors getting Pfizer’s updated booster might have a slightly higher risk of stroke. But FDA safety expert Richard Forshee said data from Medicare and multiple other health systems — including in other countries — found no sign of trouble, leading the government to conclude it’s unlikely the red flag was real.
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AP Health Writer Matthew Perrone contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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A Food and Drug Administration panel is set to vote Thursday on what could be a major shift in strategy when it comes to COVID-19 vaccinations.
The plan being considered would have the agency simplify the current process and recommend one shot per year, similar to flu vaccines.
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In briefing documents released Monday, the FDA said in part on the simplified process, “Multiple COVID-19 vaccine compositions and immunization schedules have been authorized or approved in the U.S., complicating vaccine administration, communication, and uptake. An approach to both simplifying the immunization schedule and periodically updating the composition of COVID-19 vaccines as needed, requires consideration.”
The document also said the simplified schedule would help vaccinations overall and have less complex communication when it comes to who should receive the vaccine.
The panel will also consider retiring the original vaccines and offer only the updated shots from Pfizer and Moderna, the bivalent mRNA boosters. These boosters are designed to target the original strain of COVID-19, as well as the omicron subvariants.
The updated doses are known as “bivalent” vaccines. According to the FDA, they “contain two messenger RNA (mRNA) components of SARS-CoV-2 virus: one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”
It is also considering in its proposed simplified schedule that young children and older adults would be the ones to receive a two-dose series while the rest of the general population would receive one.
“In age and risk groups presumed to have ‘insufficient preexisting immunity,’ two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for the desired duration,” the documents said.
Some advisors are warning there is little research to support the plan.
However, the Florida Department of Health has completely different guidelines and doesn’t recommend mRNA shots for any man under 40 or any healthy children, saying the potential side effects outweigh the possible benefits.
VRBPAC 01.26.23 Meeting Briefing Document FDA by News 6 WKMG-TV on Scribd
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U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot.
The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus.
This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster.
The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those eligible have received the latest boosters authorized in August.
The FDA will ask its panel of outside vaccine experts to weigh in at a meeting Thursday. The agency is expected to take their advice into consideration while deciding future vaccine requirements for vaccine makers.
In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.
For adults with weakened immune systems and very small children, a two-dose combination may be needed for protection. FDA scientists and vaccine companies would study vaccination, infection rates and other data to decide who should receive a single shot versus a two-dose series.
FDA will also seek input on switching all vaccines to target the same strains. That step would be needed to make the shots interchangeable, doing away with the current complicated system of primary vaccinations and boosters.
The initial shots from Pfizer and Moderna — called the primary series — target the strain of the virus that first emerged in 2020 and quickly swept across the world. The updated boosters launched last fall were also tweaked to target omicron relatives that had been dominant.
Under FDA’s proposal, the agency, independent experts and manufacturers would decide annually on which strains to target by the early summer, allowing several months to produce and launch updated shots before the fall. That’s roughly the same approach long used to select the strains for the annual flu shot.
Ultimately, FDA officials say moving to an annual schedule would make it easier to promote future vaccination campaigns, which could ultimately boost vaccination rates nationwide.
The original two-dose COVID shots have offered strong protection against severe disease and death no matter the variant, but protection against mild infection wanes. Experts continue to debate whether the latest round of boosters significantly enhanced protection, particularly for younger, healthy Americans.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Total Doses Distributed = 950,455,575. Total Doses Administered = 667,815,331. Number of People Receiving 1 or More Doses = 268,765,902. Number of People Fully Vaccinated = 229,508,443.
COVID-19 Vaccination Data Updates
WKMG News 6 & ClickOrlando
China on Thursday accused “some Western media” of bias, smears and political manipulation in their coverage of China’s abrupt ending of its strict “zero-COVID” policy, as it issued a vigorous defense of actions taken to prepare for the change of strategy.
The move in December to end mass testing and quarantines led to a sharp rise in cases, with some hospitals and crematoriums overwhelmed with victims.
An editorial in the ruling Communist Party mouthpiece People’s Daily outlined what it called China’s “optimization and control measures” and blasted reports by media outlets they didn’t identify as “completely biased hype, smear and political manipulation with ulterior motives.”
Since the initial wave of new cases, life in much of China has largely returned to normal, although officials have expressed concern about a further spread of the virus into the countryside during the Lunar New Year travel rush now underway.
Despite that, the editorial said many localities have “passed the peak of the epidemic, and production and life are speeding up to return to normal.”
“Zero-COVID,” as the strategy came to be known, sought to track and isolate every case of infection, along with those who had contact with them and even third-hand contacts. It confined millions of people in cities such as Shanghai to their homes for two months or longer, with many suffering from food shortages and lack of access to health care.
China strongly defended the policy but began dismantling it under economic pressure and after highly rare street protests broke out in Beijing and other major cities denouncing the ruling party and its leader, Xi Jinping. On Jan. 8, it took the further step of eliminating the requirement that those arriving from abroad undergo lengthy and expensive quarantines.
China rejected both foreign and domestic criticism of the policy’s excesses, denouncing earlier calls from the World Health Organization for it to adjust to changes in the nature of the virus, calling them “irresponsible.”
That made the abrupt mid-winter shift to a policy of merely seeking to prevent the most serious cases all the more jarring for the population, many of whom have defied censors to express anger online. Virtually overnight, testing stations where people had stood in long lines disappeared, while field hospitals used to quarantine millions simply packed up.
China also ceased publishing figures on new cases and deaths, which it had long been suspected of underreporting, leading to further complaints from the WHO and foreign nations about a lack of transparency. Unconfirmed estimates now put numbers of new cases at tens of thousands a day, with up to 85% of the population in some provinces having become infected.
China has also rejected calls to release more data and provide more information about the origin of the virus, first detected in the central Chinese city of Wuhan in late 2019, accusing those making the requests of “politicizing” the issue.
The government has also lashed out at countries that require travelers coming from China to show a negative virus test, calling the demand “discriminatory” even though it requires the same of anyone entering China.
That defensive attitude was reflected in the People’s Daily editorial, which said: “Thanks to meticulous medical preparations, sufficient production capacity reserves, and strong organizational planning and equipment, China has smoothly passed the adaptation period after the ‘transition’ and ‘shift’ of the epidemic prevention policy.”
“In the face of China’s prevention and control achievements, any political manipulation is pale and powerless,” it added, citing endorsements from academics in Nigeria, Kenya and Russia, all close Chinese diplomatic partners.
“All parties should focus on fighting the epidemic itself, avoid any words or deeds that politicize the epidemic, strengthen solidarity and cooperation, and work together to defeat the epidemic,” the editorial said.