US experts discuss COVID boosters for the fall and beyond

US experts discuss COVID boosters for the fall and beyond

WKMG News 6 & ClickOrlando

While many Americans are trying to move on with their lives after two years of the COVID-19 pandemic, U.S. health officials are debating the best way to use vaccines to stay ahead of the coronavirus.

A panel of U.S. vaccine experts was meeting Wednesday to discuss key questions for future COVID-19 booster campaigns. The Food and Drug Administration’s vaccine advisers won’t make any binding decisions during the virtual meeting, but their advice could shape the government’s approach for years to come.

FDA vaccine chief Dr. Peter Marks told reporters last week that it wouldn’t be surprising if the agency authorized another booster dose in the fall to protect most Americans against the latest coronavirus mutations. He opened Wednesday’s meeting by cautioning that waning vaccine protection, new variants and colder weather later this year could raise the risk of more surges.

“All that taken together makes us conclude that a general discussion of booster vaccination against COVID-19 is warranted at this time so that we can potentially intervene,” Marks said.

Some of the key questions for the panel:

HOW SHOULD THE U.S. DECIDE WHEN TO LAUNCH FUTURE ROUNDS OF BOOSTER SHOTS? WHO SHOULD GET THEM?

Last week, the FDA authorized an extra Pfizer or Moderna shot for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of another possible surge.

Only about half of Americans eligible for a third shot have gotten one. And some independent experts disagree about the need for even that additional protection in healthy individuals, due to limited evidence of the benefit or how long it might last.

The last U.S. wave was driven by the omicron variant. During that surge, two doses were nearly 80% effective against needing a ventilator or death — and a booster pushed that protection to 94%, federal scientists have reported. COVID-19 cases have dropped to low levels in the U.S., but health officials are warily watching an omicron sibling that now accounts for most cases.

WHAT’S THE PROCESS FOR UPDATING VACCINES TO ADDRESS NEW VARIANTS?

All the COVID-19 vaccines now used in the U.S. are based on the original coronavirus version that emerged in late 2019. Updating the vaccines will be a complex task, requiring coordination between the FDA, manufacturers and global health authorities.

The process for updating annual flu vaccines offers one possible model for dealing with mutations. The FDA panel is expected to discuss the strengths and weakness of adopting such an approach.

Twice a year, World Health Organization experts recommend updates to flu vaccines to target emerging strains. The FDA then brings those recommendations to its own vaccine panel, which votes on whether they make sense for the U.S., setting the stage for manufacturers to tweak their shots and begin mass production.

But COVID-19 hasn’t yet fallen into a predictable pattern like the flu. And vaccine manufacturers will likely need more time to conduct additional studies of their COVID-19 vaccines, which don’t have the same decades-long record of safety and effectiveness as flu shots.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

EU officials say it’s too early to consider 4th COVID dose

EU officials say it’s too early to consider 4th COVID dose

WKMG News 6 & ClickOrlando

European health officials say it’s too early to consider giving a fourth dose of messenger RNA coronavirus vaccines to most people, but say an extra booster can be administered to those over age 80.

In a joint statement on Wednesday, the European Medicines Agency and the European Centre for Disease Prevention and Control said they had reviewed data for a fourth dose of the COVID-19 vaccines made by Pfizer-BioNTech and Moderna Inc. They included real-world data from Israel, where research has shown that a second booster provides only marginally higher protection.

“There is currently no clear evidence in the EU that vaccine protection against severe disease is waning substantially in adults with normal immune systems aged 60 to 79 years,” the agencies said. But the organizations acknowledged that if the pandemic situation changes, it might be necessary to consider a second booster dose in that age group.

For adults younger than 60 with no underlying health issues, “there is currently no conclusive evidence that vaccine protection against severe disease is waning or that there is an added value of a fourth dose,” the EMA and ECDC said.

The advice stands in contrast to guidance issued by the U.S. Food and Drug Administration, which decided last week that Americans 50 and older can get a second COVID-19 booster if it’s been at least four months since their last vaccination.

The U.S. Centers for Disease Control and Prevention later recommended the extra shot as an option but stopped short of urging that those eligible rush out and get it right away. That decision expands the additional booster to millions more Americans.

The European recommendations come as numerous countries across the continent have dropped nearly all their COVID-19 restrictions and are battling a surge of the disease fueled by the hugely infectious omicron subvariant BA.2. The variant’s milder disease has not driven up hospitalizations and deaths as in previous waves and authorities in many countries hope their high immunization rates will ward off any major disruptions to society.

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WHO: COVID cases and deaths continue to fall globally

WHO: COVID cases and deaths continue to fall globally

WKMG News 6 & ClickOrlando

The number of coronavirus cases reported globally has dropped for a second consecutive week and confirmed COVID-19 deaths also fell last week, according to a World Health Organization report issued Wednesday.

In its latest pandemic report, WHO said 9 million cases were reported, a 16% weekly decline, and more than 26,000 new deaths from COVID-19. The U.N. health agency said confirmed coronavirus infections were down in all regions of the world.

However, it warned that the reported numbers carry considerable uncertainty because many countries have stopped widespread testing for the coronavirus, meaning that many cases are likely going undetected.

WHO said it was also tracking an omicron variant that is a recombination of two versions: BA.1 and BA.2, which was first detected in Britain in January. WHO said early estimates suggest the recombined omicron could be about 10% more transmissible than previous mutations, but further evidence is needed.

The agency has continued to warn countries not to drop their COVID-19 protocols too quickly and predicted that future variants could spread easily if surveillance and testing systems are shelved.

Last week, the U.K. said COVID-19 had hit record levels across the country, with government statistics estimating that about 1 in 13 people were infected. Those figures came on the same day the British government abandoned its free testing program.

Meanwhile, Chinese authorities conducted more mass testing this week across Shanghai, which remains in lockdown following another jump in infections; the city has recorded more than 90,000 cases but no deaths during the pandemic.

Despite growing public frustration and concerns about economic effects, China says it is sticking to its hard-line “zero-tolerance” approach mandating lockdowns, mass testing and the compulsory isolation of all suspected cases and close contacts. Following a public uproar, Shanghai authorities said Wednesday they would allow at least some parents to stay with children infected with COVID-19, making an exception to a policy of isolating anyone who tests positive.

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German minister backs off ending compulsory COVID isolation

German minister backs off ending compulsory COVID isolation

WKMG News 6 & ClickOrlando

Germany’s health minister has backed off a decision to end compulsory isolation for people who test positive for COVID-19, declaring that it was a mistake and sent the wrong signal.

Health Minister Karl Lauterbach said on Monday that obligatory self-isolation, usually for 10 days — which can be cut to seven days with a negative test — would be scrapped May 1 and replaced with a strong recommendation to isolate for five days. Local health offices would still have ordered infected people in health facilities to stay off work.

Lauterbach, who first announced his change of heart on a television talk show Tuesday night, said Wednesday that the idea “was a mistake I am personally responsible for.”

“I have withdrawn the proposal because the completely wrong impression would have arisen that either the pandemic is over or the virus has become significantly more harmless than was assumed in the past,” he told reporters in Berlin.

He noted that nearly 350 coronavirus-related deaths were recorded on Tuesday, and said Germany has case numbers “that are much too high” and that long COVID is “a big problem.”

Lauterbach said his aim had been to lighten the burden on local health offices and that he will instead do so by lifting a requirement for the contacts of infected people to quarantine. He said he would propose keeping a compulsory five-day isolation period for inviduals with COVID-19 in place.

Infection levels in Germany have been drifting down, and most coronavirus restrictions have recently been relaxed.

Lauterbach, an epidemiologist and longtime lawmaker with Chancellor Olaf Scholz’s center-left party, was one of Germany’s most prominent voices urging caution and strict measures against the coronavirus in the earlier stages of the pandemic.

Since becoming health minister in December, he has tried to balance that approach with the political challenges of a diverse three-party coalition government and the impact of the omicron variant, which has brought high case numbers but in many cases relatively mild illness.

Speaking on Deutschlandfunk radio, opposition leader Friedrich Merz assailed what he called a “breathless” style of government “with decisions that don’t last for 48 hours.”

Merz also criticized the government’s approach to a potential vaccination mandate ahead of parliamentary votes set for Thursday. Scholz favors a mandate, but left it to lawmakers to come up with cross-party proposals amid divisions in his own government.

Backers of obligatory vaccinations for adults backed off that idea this week, at least for now, after struggling to build enough support.

They agreed to a compromise that foresees a mandate for people age 60 and over taking effect in October. Parliament could decide this fall whether to extend the requirement to all residents over 18. It’s unclear whether that or any other proposal has a chance of winning a majority in parliament.

Some lawmakers in the governing parties oppose any mandate. Merz said his center-right party is sticking to its own proposal, which foresees setting up a national vaccination register but doesn’t include an immediate vaccination mandate.

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US pulls GSK’s COVID drug as omicron sibling dominates cases

US pulls GSK’s COVID drug as omicron sibling dominates cases

WKMG News 6 & ClickOrlando

GlaxoSmithKline’s IV drug for COVID-19 should no longer be used because it is likely ineffective against the omicron subvariant that now accounts for most U.S. cases, federal health regulators said Tuesday.

The Food and Drug Administration announced that the company’s antibody drug sotrovimab is no longer authorized to treat patients in any U.S. state or territory. The decision was expected, because the FDA had repeatedly restricted the drug’s use in the Northeast and other regions as the BA.2 version of omicron became dominant.

The Centers for Disease Control and Prevention said Tuesday that BA.2 accounts for 72% of the COVID-19 cases sequenced by health authorities. Some experts have warned of a BA.2-driven surge similar to those that have hit European countries, though U.S. case counts have yet to rise.

The drug from Glaxo and codeveloper Vir Biotechnology is the latest antibody medication to be sideline by the mutating coronavirus, which previously rendered drugs from Eli Lilly and Regeneron obsolete. The FDA pulled their authorization in January after concluding they were ineffective against the original version of omicron.

The decision leaves doctors and hospitals with only one antibody still authorized for use against routine COVID-19 cases: a different Eli Lilly drug that regulators say appears effective against BA.2.

Doctors can also prescribe antiviral pills that haven’t been impacted by omicron’s mutations, which mainly affect the virus’ signature spike protein. The pills from Pfizer and Merck mostly have been shipped to pharmacy chains and medical clinics in hopes of getting them to patients early enough to work.

The federal government purchased nearly $2 billion worth of Glaxo’s drug, shipping more than 900,000 doses to U.S. states since last fall.

London-based Glaxo said last month it is studying a higher dose of the antibody against BA.2. But the FDA would need to review and authorize the company’s request before giving the OK to resume use in the U.S.

The antibody drugs are laboratory-made versions of virus-blocking proteins found in the human body. Each antibody is formulated to attack a specific invader — such as a virus or bacteria — but the medications need to be reformulated as the coronavirus repeatedly mutates.

The drugs are prescribed for early use in people with a recent COVID-19 infection who face increased risk of severe disease or death, including seniors or people with diabetes, heart disease and other common health problems.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.