The European Medicines Agency has recommended the authorization of two coronavirus vaccines made by Pfizer-BioNTech and Moderna Inc., tweaked to include protection against an early version of the omicron variant.
In a statement on Thursday, the EU drug regulator said the two messenger RNA boosters offered protection both against the original version of COVID-19 and the omicron subvariant BA.1, which has since been overtaken globally by later omicron subvariants BA.4 and BA.5. Nearly 80% of coronavirus cases worldwide are now being caused by omicron BA.5, according to the World Health Organization.
The decision comes a day after the U.S. drug regulator cleared updated versions of COVID-19 vaccines incorporating protection against the later subvariants, after telling pharmaceuticals in June that any updated boosters must target the most recent versions of omicron.
The European Medicines Agency said adapted vaccines are expected “to help maintain optimal protection against COVID-19 as the virus evolves.” The regulator is also currently reviewing an updated version of the Pfizer-BioNTech vaccine that aims to protect against the later BA.4 and BA.5 omicron variants.
Scientists hope the new boosters will trigger a strong response from the immune system to prevent not just serious illness but perhaps milder infections also – much like the original vaccines did earlier in the pandemic, before super-contagious mutants emerged.
It’s unclear how well the updated boosters will work since experts are still gathering data. But there’s evidence that they are safe, so waiting for more study on their effectiveness would risk another mutation appearing before people are immunized.
Last month, British authorities cleared an updated version of the Moderna booster that included protection against omicron subvariant BA.1, saying the shots would be offered to people 50 and over beginning in September.
In Germany, health minister Karl Lauterbach said that inoculations with the new vaccines could start next week and that “now is the optimal time to close vaccination gaps for the fall.”
Globally, coronavirus cases and deaths have been dropping for weeks, but scientists expect a surge of hospitalizations and deaths with the coming onset of winter in the northern hemisphere.
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Geir Moulson in Berlin contributed to this report.
Chinese authorities have locked down Chengdu, a southwestern city of 21 million people, following a spike in COVID-19 cases.
Residents have been ordered to stay home, and about 70% of the flights have been suspended to and from the city, which is a major transit hub in Sichuan province and a governmental and economic center.
The start of the new school term has been delayed, although public transport continues to operate and citizens are permitted to leave the city if they can show a special need.
Under the rules announced Thursday, just one member of each family who can show a negative virus test within the past 24 hours is allowed out per day to buy necessities.
No word was issued on when the lockdown would be lifted.
Similar measures have seen millions of people confined to their homes in the northeastern city of Dalian, as well as Shijiazhuang, the capital of Hebei province that borders the capital Beijing.
Chengdu has reported around 1,000 cases in the latest outbreak and no deaths from the latest round of domestic transmission, but the extreme measures reflect China’s rigid adherence to its “zero-COVID” policy that has exacted a major toll on the economy, with lockdowns, business closures and mass testing requirements.
China says the measures are necessary to prevent a wider spread of the virus, which was first detected in the central Chinese city of Wuhan in late 2019. The fear of being caught in a lockdown situation or sent to a quarantine facility for even being in proximity with a person who tested positive has severely constrained people’s work, consumption and travel habits.
The Biden administration hopes to make getting a COVID-19 booster as routine as going in for the yearly flu shot.
That’s at the heart of its campaign to sell the newly authorized shot to an American public that has widely rejected COVID-19 boosters since they first became available last fall.
Shots of the updated boosters, specifically designed by Pfizer and Moderna to respond to the omicron strain, could start within days. The U.S. government has purchased 170 million doses and is emphasizing that everyone will have free access to the booster.
White House COVID-19 coordinator Dr. Ashish Jha said this latest round of shots will offer protection during the busy cold and flu season, with the hope of transitioning people to get the vaccine yearly. Typically, at least half of U.S. adults get a flu shot.
“We expect them to provide more durable protection over time,” Jha said in an interview Wednesday with The Associated Press. “The goal very much is to get to a point where people get their COVID shot on a regular basis, the way they do their flu shot.”
Community health workers in North Carolina, home to the country’s lowest COVID-19 booster rate, like the strategy, especially because of confusion among some people about vaccine schedules.
“I believe in keeping things simple,” said Marty Stamey, an outreach coordinator for the Mountain Area Health Education Center in western North Carolina. “I’ve heard a lot of people say, ‘I think I’ll just wait and try to do it like the flu shots.’”
The White House plan also relies in part of on local health departments, providers and community groups to reach out and encourage people to get the updated booster. Pharmacies, health providers and state or local health departments are preparing to send text messages to millions of people that will encourage them to get a booster this fall, White House officials said.
Jha said he recommends most Americans get the booster by the end of October.
Still, this latest vaccination campaign faces several challenges.
Congress also has not moved forward on President Joe Biden’s $22.5 billion request earlier this year for the COVID-19 response. Republicans criticized the request, pointing to the $1.9 trillion already spent on responding to the pandemic. Running short on funds, the government announced it would stop shipping COVID-19 tests to people’s homes after Friday.
And COVID-19 funding is drying up for many of the community groups that received millions of federal tax dollars to hire workers who spent months reaching deep into neighborhoods with door knocks, mobile vaccine clinics and posters encouraging people to inoculate against COVID-19.
White House officials say those local leaders deserve a lot of credit for stamping out misinformation about the COVID-19 vaccine and convincing many around the country that the shot will protect them.
“Those are the really critical messengers,” Jha said.
That on-the-ground work has been crucial to getting people vaccinated in the rural, Spanish- and Haitian-speaking communities that the Migrant Clinicians Network has reached throughout Texas, California and Maryland with its $8.5 million federal grant.
“Simply having the vaccines available is one thing, but getting the shots in the arms is another,” said Amy Liebman, a chief program officer for the nonprofit group.
Dr. Niharika Khanna at the University of Maryland School of Medicine has just started making progress on convincing new mothers that the vaccine is safe and effective for their babies.
Her program, which has hired more than 269 health workers and administered more than 12,000 vaccinations and boosters across Delaware, Maryland, Virginia and West Virginia, isn’t quite ready to transition back to pushing COVID-19 boosters.
“All of these people, all of these relationships we’ve carefully cultivated are at risk for falling apart,” Khanna said. “Today if you were to say to me switch to booster, I’d say no. I need another two to three weeks to really get these people going.”
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AP White House Correspondent Zeke Miller contributed to this report.
It was a long road to recovery for 22-year-old Sebastian Deleon, who lost most of his motor skills six years ago after suffering a brain-eating amoeba.
“For the first couple of years, it was kind of hard. The part that I most remember is the part that I was in rehab,” Deleon recalled. “It was tough. I had to, like, learn how to walk, how to write again, how to do all the basic stuff again.”
In 2016, Deleon — who was 16 years old at the time — remembered experiencing an unbearable headache while on vacation with his family in Orlando.
“This headache was different. It felt more like — the description that I kept saying at the hospital was that it felt there was a smooth rock on top of my head, and someone was pushing it down,” he said.
Those were the initial symptoms of the deadly brain-eating amoeba.
“I couldn’t get up, and I couldn’t move and stuff like that, so my parents were like, ‘OK, there’s something wrong with this boy. We need to take him somewhere,’” he said. “We got in the car. It felt like I was in one of those roller coasters spinning around and around and around, and I had to wear sunglasses, and the sun wasn’t even out.”
From his home in Weston, Florida, Deleon said he contracted the amoeba after swimming in a pond near his home.
“It was more of a pond, but we used to call it the lake because it was a huge pond, but the only thing was that it was still-water,” the college student recalled.
At the time, Deleon said he had never heard about the condition or the risk of swimming in freshwater.
“I went in, I believe, like, three times or twice,” he said.
Doctors told him it was one of those times the amoeba made its way up his nose and into his brain.
“That’s probably when I got it — that I did jump in there, and I did not cover my nose, and I just cannon-balled in a way,” he said.
The latest report from the Centers for Disease Control and Prevention shows that from 1962 to 2021, there have been 154 known cases of people contracting brain-eating amoebas, and only four people have survived.
Three of the survivors, including Sebastian, were treated with the drug commercially known as Impavido.
“We felt optimistic at the very beginning because we knew that this was the first time a patient ever had received the drug while still conscious,” Todd McLaughlan, the CEO of Orlando-based Profounda, Inc. — which is the sole distributor of Impavido in the U.S. — said.
The drug was brought from Germany by the CDC after it showed promise in treating the brain-eating amoeba found in warm freshwater.
“The most important thing is a proper diagnosis, and the second thing is speed: making sure you get that drug to them as quickly as possible,” McLaughlan said. “Think of the treatment for a severe car accident or severe brain trauma. This is to prevent the brain from swelling.”
According to Profounda, only 26 hospitals carry the drug nationwide. Seven of those hospitals are in Florida.
“It’s not anywhere near where it needs to be,” McLaughlan said.
For Sebastian, he hopes sharing his story will shed light on a condition that’s left so many families in heartbreak.
“We should probably have more research into this because there’s no reason why a kid should go into a pond and be scared that could get something that we barely know what to do with,” Sebastian said. “I really do think that we should spread more awareness about this because it’s something that no one, almost nobody, knows about it, and yet it’s so fatal.”
Sebastian has made a full recovery and is now a pursuing a degree in criminal justice.
California won’t allow teens age 15 and up to be vaccinated against the coronavirus without their parents’ consent.
State Sen. Scott Wiener, the bill’s author, announced Wednesday he won’t put the measure up for a vote in the state Assembly because it doesn’t have enough support to pass.
Minors age 12 to 17 in California already can receive vaccinations for hepatitis B and HPV, which prevent sexually transmitted diseases, without permission from their parents or guardians. The bill would have allowed teens 15 and older to receive any vaccine that has been approved by the U.S. Food and Drug Administration and Centers for Disease Control and Prevention, even if their parents objected.
Wiener, a Democrat from San Francisco, blamed the lack of support on “months of harassment and misinformation” by “a small but highly vocal and organized minority of anti-vaxxers.”
“The anti-vaxxers may have prevailed in this particular fight, but the broader fight for science and health continues,” he said in a statement.
A coalition of groups opposed to vaccine mandates called it a “blatant, dangerous trampling of California parents’ and guardians’ ability to protect and care for their children.”
A Voice for Choice Advocacy said minors may not know their full medical history and the potential risks. And if they don’t tell their parents that they obtained the vaccine on their own, the group said parents may not know what’s wrong if their child has an adverse reaction.
Vaccine consent ages vary across the country. Alabama allows children to consent to vaccines starting at age 14, Oregon at 15 and Rhode Island and South Carolina at 16. Cities including Philadelphia and Washington, D.C., allow children age 11 and up to consent to COVID-19 vaccines, and in San Francisco the age is 12 and older.
The teen consent bill was one several coronavirus-related bills that faced heavy opposition.
Gov. Gavin Newsom and Democratic Sen. Richard Pan both delayed until next year measures relating to school vaccinations, while Democratic Assemblymember Buffy Wicks withdrew her bill that would have forced all California businesses to require coronavirus vaccines for their employees.
Another Pan bill still moving forward would require schools create COVID-19 testing plans.
Also still under consideration are a bill by Democratic Assemblymember Evan Low that would make doctors spreading coronavirus misinformation or disinformation subject to discipline for professional misconduct, and one by Democratic Assemblymember Akilah Weber that would require health care providers, schools, child care facilities and others to disclose certain patient information to the California Department of Public Health and local health officials.
The number of new coronavirus cases and deaths reported globally continued to fall nearly everywhere in the world in what the World Health Organization described as a “welcome decline” at a media briefing on Wednesday.
The U.N. health agency said there were 4.5 million new COVID-19 cases reported last week, a 16% drop from the previous week. Deaths were also down by 13%, with about 13,500 fatalities. WHO said COVID-19 infections dropped everywhere in the world while deaths decreased everywhere except for Southeast Asia, where they climbed by 15% and in the Western Pacific, where they rose by 3%.
WHO Director-General Tedros Adhanom Ghebreyesus warned that with the coming onset of winter in the Northern Hemisphere and the possible emergence of a more dangerous new COVID-19 variant, experts expect to see a spike in hospitalizations and deaths. Tedros said vaccination rates, even in rich countries, were still too low, noting that 30% of health workers and 20% of older people remain unimmunized.
“These vaccination gaps pose a risk to all of us,” he said. “Please get vaccinated if you are not and a booster if it’s recommended that you have one.”
In the U.S., the Food and Drug Administration cleared its first update to COVID-19 vaccines on Wednesday, booster doses that target today’s most common omicron strain. Authorities said shots could begin within days.
Until now, COVID-19 vaccines have targeted the original coronavirus strain, even as wildly different mutants emerged. The new U.S. boosters are combination, or “bivalent,” shots. They contain half that original vaccine recipe and half protection against the newest omicron versions, called BA.4 and BA.5, which are considered the most contagious yet.
Earlier this month, Britain decided it would offer adults 50 and over a different booster option from Moderna, a combo shot targeting that initial BA.1 omicron strain.
On Friday, the European Medicines Agency will consider whether to authorize the combination COVID-19 vaccine including BA.1 made by Pfizer-BioNTech and Moderna. Another version of the Pfizer-BioNTech vaccine incorporating the BA.5 subvariant of omicron is also under review by the EU regulator.
