The pharmaceutical developer Novavax says it has asked the European Medicines Agency to extend the authorization of its coronavirus vaccine to children aged 12 to 17 amid a surge of disease across the continent.
In a statement on Thursday, Novavax said its request is based on data from research in more than 2,200 adolescents aged 12 to 17 in the U.S., which found its vaccine to be about 80% effective against COVID-19. The study was done when the delta variant was the predominant virus in the U.S. The main side effects reported were pain at the injection site, headache and tiredness.
The EU drug regulator gave Novavax’s two-dose COVID-19 vaccine for adults the green light in December; the shot has also been cleared by Indonesia, Australia and the World Health Organization, among others. The EMA has previously OK’ed vaccines made by Pfizer-BioNTech and Moderna for use in children from age 6.
The Novavax vaccine relies on an older technology that’s been used for years to make shots for diseases like influenza and pertussis. The Maryland-based Novavax drugmaker uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists then extract and purify the protein and then mix in an immune-boosting chemical.
Novavax has run into repeated production problems and mainly relies on other factories to make its vaccine. It has delayed delivery of its shots to numerous countries in Europe and despite pledges to make 250 million doses available to COVAX, not a single vaccine has been shared with the U.N.-backed effort to distribute shots to poorer countries.
According to the European Centre for Disease Prevention and Control, more than half of adolescents in the EU have not yet been fully vaccinated against COVID-19. Numerous countries across the continent have recently seen a jump in coronavirus cases, due largely to the spread of the hugely infectious omicron subvariant BA.2 and the relaxation of nearly all COVID-19 protocols.
The city of Shanghai prepared Thursday to reopen its eastern half and shut its western half, while authorities elsewhere announced the lifting of a citywide lockdown in the province hit hardest by China’s ongoing omicron-driven coronavirus outbreak.
Residents of the city of Jilin will be able to move about freely starting Friday for the first time in more than three weeks, state broadcaster CCTV said, citing a notice issued by the city. They will be required to wear masks and, when indoors, stay one meter (three feet) apart. Public gatherings in parks and squares are prohibited.
The spread of COVID-19 has been brought under control in Jilin city but not in the rest of Jilin province, officials said at a news conference, according to CCTV. Some progress has been made in Changchun, the provincial capital and an auto manufacturing hub that has been locked down since March 11.
China has been battling its largest COVID-19 outbreak since the initial one in early 2020 that devastated the city of Wuhan and other parts of Hubei province. By far, most of the cases have been in Jilin province, which borders North Korea in China’s industrial northeast. Smaller outbreaks have popped up across the country, including Shanghai, the financial capital and China’s largest city with 26 million people.
The two-phase lockdown of Shanghai, being carried out over eight days, has shaken global markets worried about the possible economic impact. China’s manufacturing activity fell to a five-month low in March, a monthly survey showed Thursday, as lockdowns and other restrictions forced factories to suspend production.
Pudong, the half of Shanghai on the east side of the Huangpu River, was to reopen at 5 a.m. Friday after a four-day lockdown during which residents were tested for the coronavirus and isolated if the result was positive. A lockdown of Puxi on the west side of the river was starting at 3 a.m.
About 16 million people will be tested in Puxi. Residents are not allowed to leave their neighborhoods or housing compounds during the four-day lockdown, with groceries or meals delivered to their complexes.
China on Thursday reported 8,559 new cases in the previous 24-hour period, of which 6,720 had no symptoms. The proportion of asymptomatic cases has been higher than in previous outbreaks, particularly in Shanghai. About 100 of the new cases were imported ones among people who had recently arrived from abroad.
When the end of the COVID-19 pandemic comes, it could create major disruptions for a cumbersome U.S. health care system made more generous, flexible and up-to-date technologically through a raft of temporary emergency measures.
Winding down those policies could begin as early as the summer. That could force an estimated 15 million Medicaid recipients to find new sources of coverage, require congressional action to preserve broad telehealth access for Medicare enrollees, and scramble special COVID-19 rules and payment policies for hospitals, doctors and insurers. There are also questions about how emergency use approvals for COVID-19 treatments will be handled.
The array of issues is tied to the coronavirus public health emergency first declared more than two years ago and periodically renewed since then. It’s set to end April 16 and the expectation is that the Biden administration will extend it through mid-July. Some would like a longer off-ramp.
Transitions don’t bode well for the complex U.S. health care system, with its mix of private and government insurance and its labyrinth of policies and procedures. Health care chaos, if it breaks out, could create midterm election headaches for Democrats and Republicans alike.
“The flexibilities granted through the public health emergency have helped people stay covered and get access to care, so moving forward the key question is how to build on what has been a success and not lose ground,” said Juliette Cubanski, a Medicare expert with the nonpartisan Kaiser Family Foundation, who has been researching potential consequences of winding down the pandemic emergency.
MEDICAID CHURN
Medicaid, the state-federal health insurance program for low-income people, is covering about 79 million people, a record partly due to the pandemic.
But the nonpartisan Urban Institute think tank estimates that about 15 million people could lose Medicaid when the public health emergency ends, at a rate of at least 1 million per month.
Congress increased federal Medicaid payments to states because of COVID-19, but it also required states to keep people on the rolls during the health emergency. In normal times states routinely disenroll Medicaid recipients whose incomes rise beyond certain levels, or for other life changes affecting eligibility. That process will switch on again when the emergency ends, and some states are eager to move forward.
Virtually all of those losing Medicaid are expected to be eligible for some other source of coverage, either through employers, the Affordable Care Act or — for kids — the Children’s Health Insurance Program.
But that’s not going to happen automatically, said Matthew Buettgens, lead researcher on the Urban Institute study. Cost and lack of awareness about options could get in the way.
People dropped from Medicaid may not realize they can pick up taxpayer-subsidized ACA coverage. Medicaid is usually free, so people offered workplace insurance could find the premiums too high.
“This is an unprecedented situation,” said Buettgens. “The uncertainty is real.”
The federal Centers for Medicare and Medicaid Services, or CMS, is advising states to take it slow and connect Medicaid recipients who are disenrolled with other potential coverage. The agency will keep an eye on states’ accuracy in making eligibility decisions. Biden officials want coverage shifts, not losses.
“We are focused making sure we hold on to the gains in coverage we have made under the Biden-Harris administration,” said CMS Administrator Chiquita Brooks-LaSure. “We are at the strongest point in our history and we are going make sure that we hold on to the coverage gains.”
ACA coverage — or “Obamacare” — is an option for many who would lose Medicaid. But it will be less affordable if congressional Democrats fail to extend generous financial assistance called for in President Joe Biden’s social legislation. Democrats stalling the bill would face blame.
Republicans in mostly Southern states that have refused to expand Medicaid are also vulnerable. In those states, it can be very difficult for low-income adults to get coverage and more people could wind up uninsured.
State Medicaid officials don’t want to be the scapegoats. “Medicaid has done its job,” said Matt Salo, head of the National Association of Medicaid Directors. “We have looked out for physical, mental and behavioral health needs. As we come out of this emergency, we are supposed to right-size the program.”
TELEHEALTH STATIC
Millions of Americans discovered telehealth in 2020 when coronavirus shutdowns led to the suspension of routine medical consultations. In-person visits are again the norm, but telehealth has shown its usefulness and gained broader acceptance.
The end of the public health emergency would jeopardize telehealth access for millions enrolled in traditional Medicare. Restrictions predating COVID-19 limit telehealth mainly to rural residents, in part to mitigate against health care fraud. Congress has given itself 151 days after the end of the public health emergency to come up with new rules.
“If there are no changes to the law after that, most Medicare beneficiaries will lose access to coverage for telehealth,” the Kaiser Foundation’s Cubanski said.
A major exception applies to enrollees in private Medicare Advantage plans, which generally do cover telehealth. However, nearly 6 in 10 Medicare enrollees are in the traditional fee-for-service program.
Widespread access to COVID-19 vaccines, tests and treatments rests on legal authority connected to the public health emergency.
One example is the Biden administration’s requirement for insurers to cover up to eight free at-home COVID-19 tests per month.
An area that’s particularly murky is what happens to tests, treatments and vaccines covered under emergency use authorization from the Food and Drug Administration.
Some experts say emergency use approvals last only through the duration of the public health emergency. Others say it’s not as simple as that, because a different federal emergency statute also applies to vaccines, tests and treatments. There’s no clear direction yet from health officials.
The FDA has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for those 16 and older and Moderna’s for those 18 and older, so their continued use would not be affected.
But hospitals could take a financial hit. Currently they’re paid 20% more for the care of COVID-19 patients. That added payment is only for the duration of the emergency.
And Medicare enrollees would have more hoops to jump through to be approved for rehab in a nursing home. A suspended Medicare rule requiring a prior three-day hospital stay would come back into effect.
Health and Human Services Secretary Xavier Becerra recently told The Associated Press that his department is committed to giving “ample notice” when it ends the public health emergency.
“We want to make sure we’re not putting in a detrimental position Americans who still need our help,” Becerra said. “The one that people are really worried about is Medicaid.”
Total Doses Distributed = 702,181,465. Total Doses Administered = 560,419,082. Number of People Receiving 1 or More Doses = 255,428,475. Number of People Fully Vaccinated = 217,556,439.
Many Americans now can get a second COVID-19 booster, but it’s hard to tell who really needs another shot right now and who could wait.
The Food and Drug Administration authorized extra Pfizer or Moderna shots for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of a possible next coronavirus surge.
With COVID-19 cases low in the U.S., it’s easy to ignore calls for another dose — or for those who aren’t yet vaccinated or boosted to get up to date, said Dr. Erica Johnson, an infectious disease specialist at the American Board of Internal Medicine.
Her advice: If you’re on the fence, use this lull to talk with your doctor about how protected you really are — and need to be.
WHO IS ELIGIBLE FOR A SECOND BOOSTER?
Anyone 50 and older can get the extra dose at least four months after their last vaccination. So can severely immune-compromised patients, such as organ transplant recipients, as young as 12.
Adults can choose either the Pfizer or the Moderna vaccine for their extra shot, but Pfizer is the only option for children.
WHAT ABOUT PEOPLE WHO GOT JOHNSON & JOHNSON?
Adults who received J&J;’s single-dose vaccine already were eligible for a booster of any kind — and the Centers for Disease Control and Prevention recommends only some of them get another.
A new study found a Moderna or Pfizer second shot was superior to getting a second J&J; dose. So the advice is anyone who got a second J&J; shot now can choose a Moderna or Pfizer dose.
But if they already had one of those other boosters, the CDC says only those who meet the newest criteria — age or weak immune system — qualify for another.
WHAT PROMPTED THE MOVE?
Vaccines still offer strong protection against severe illness and death, but effectiveness against milder infections wanes months later. The shots also don’t work as well against new variants like the super-contagious omicron mutant as they did earlier in the pandemic.
That’s why everyone 12 and older, regardless of their health, already was urged to get a first booster for the best chance at fending off omicron. Only about half of those eligible have.
With an omicron sibling causing spikes in infections in other countries, officials are nervous the U.S. is next, prompting efforts to offer extra protection to the most vulnerable.
WHAT’S THE EVIDENCE FOR ANOTHER BOOSTER?
Many scientists say it’s limited, leaving public health officials to use their best judgment.
During the U.S. omicron wave, two Pfizer or Moderna doses plus a booster were 94% effective against death or needing a ventilator, according to a recent CDC study. That protection was lowest — 74% — in immune-compromised people, although most hadn’t gotten the already recommended third dose.
Israel began offering people 60 and older a second booster during its omicron surge. Preliminary findings posted online last week show there were fewer deaths among people who chose another booster compared to those who skipped the fourth dose.
The FDA decided to set the age limit at 50 instead of 60 because that’s when chronic illnesses like heart disease or diabetes become more common, leaving people more vulnerable to serious COVID-19.
WHO REALLY NEEDS A SECOND BOOSTER?
The CDC says an extra shot is an option — but those most likely to benefit are those most vulnerable to severe disease, including people 65 and older and 50-somethings who have multiple health problems.
WHEN SHOULD I GET IT?
Again, experts have differing opinions, partly because it’s not clear how long any extra benefit lasts.
“We can never really perfectly time when the next wave is, or when someone might encounter infection,” said Johnson, who sees patients at Johns Hopkins Bayview Medical Center in Baltimore. “To be as ready as possible, I think everyone just needs to stay as up to date as possible with their vaccines.”
Another dose now may make sense for older people and the immune-compromised, but “there’s less urgency in an otherwise healthy person,” said University of Pennsylvania immunologist E. John Wherry.
At 50, Wherry said he’s healthy enough to watch if cases rise enough to prompt another booster, but he’d prefer to wait until fall. That’s because going longer between vaccinations allows the immune response to better mature and strengthen.
___
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.
The Los Angeles City Council is scheduled to vote Wednesday on whether to end a requirement that many indoor businesses and large outdoor events verify that customers have been vaccinated against COVID-19.
The motion proposed by council President Nury Martinez would make vaccination verifications voluntary at such establishments as restaurants, bars, gyms and personal care businesses.
The measure needs at least 12 votes to pass to meet the council’s “urgency” threshold and so it could go into effect quickly. A simple majority would also approve the measure, but it wouldn’t go into effect for several weeks if that happens.
The council last week voted 13-1 to approve the measure, but it needed a unanimous vote that time, meaning a second vote was required.
Councilman Mike Bonin said at the time that he voted against lifting the requirement because of concerns about the spread of new virus variants.
“I know it feels like we’re out of the woods. It feels like we’re all going back to normal. But there’s new variants and new strains all the time,” Bonin said, adding that he hoped he was wrong.
While COVID-19 metrics have been declining in Los Angeles County, public health officials have reported an increasing number of cases of the more-infectious BA.2 subvariant.
