Moderna’s experimental COVID-19 vaccine that combines its original shot with protection against the omicron variant appears to work, the company announced Wednesday.
COVID-19 vaccine makers are studying updated boosters that might be offered in the fall to better protect people against future coronavirus surges.
Moderna’s preliminary study results show people given the combination shot experienced an eight-fold increase in virus-fighting antibodies capable of targeting the omicron mutant, the company announced.
Today’s COVID-19 vaccines all are based on the original version of the coronavirus. They’re still providing strong protection against severe disease, hospitalization and death even after the appearance of the super-contagious omicron variant — especially if people have had a booster dose.
But the virus continues to mutate rapidly in ways that let it evade some of the vaccines’ protections and cause milder infections.
So U.S. regulators, and the World Health Organization, are considering whether to order a change in the vaccine recipe for a new round of booster shots in the fall — when cold weather and kids returning to school are expected to drive yet another surge.
Key questions: How to make that change without losing the continued strong protection against COVID-19’s worst outcomes? And what’s the right variant to target? After the huge winter omicron surge, that mutant’s genetically distinct siblings now are the main threats, including one that’s fueling the current U.S. wave of infections.
The Food and Drug Administration has set a meeting in late June for its scientific advisers to debate those questions and evaluate data from vaccine makers’ tests of potential new formulas. Pfizer also is studying a combination shot, what scientists call a bivalent vaccine.
Moderna said its new study found that a month after the combo shot, recipients harbored higher omicron-fighting antibody levels — and cross-protection against other prior variants — than the original vaccine triggers. However, antibodies naturally wane so it’s not clear how long the protection against infection will last.
The study was performed in 437 people, and safety was similar to today’s boosters, Moderna said. The results were announced in a press release and haven’t undergone scientific review.
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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.
Vietnam’s health minister and the mayor of the capital Hanoi have been arrested as part of an expanding investigation into massive price gouging of COVID-19 tests, state media reported.
Nguyen Thanh Long was dismissed from his ministry post and Chu Ngoc Anh, who previously was the science minister, was fired as Hanoi mayor, Tuoi Tre online news outlet reported Tuesday. They are being investigated for abuse of power, according to the Ministry of Public Security, and have been expelled from the ruling Communist Party.
An investigation concluded earlier that mismanagement in the science and health ministries had allowed Viet A Technology Corporation to inflate prices for test kits supplied to hospitals and health centers in Vietnam.
Nearly 60 suspects including ministry officials, public health leaders and military generals have been detained or are being investigated for involvement in the price gouging, according to the Ministry of Public Security.
The report said the two officials’ violations had harmed Vietnam’s response to the COVID-19 pandemic and were costly to the state budget.
A deputy science minister, Pham Cong Tac, also was arrested Tuesday and accused of violating regulations on managing state assets.
Viet A took in $172 million for supplying its test kits in 62 localities. Its general director was arrested in December and allegedly admitted his Ho Chi Minh City-based company had inflated the selling price of a test kit to about $20, or 45% more than the original, to earn a difference of $21.5 million.
Phan Quoc Viet allegedly confessed to investigators that he paid illegal kickbacks worth $34 million to his state-owned partners who bought his test kits at the inflated prices.
American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot.
Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a more conventional technology than today’s U.S. options.
Novavax shots are already used in Australia, Canada, parts of Europe and dozens of other countries. But U.S. clearance is a key hurdle for the Maryland-based company.
FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts — whatever their reason — to consider rolling up their sleeves.
“We do have a problem with vaccine uptake that is very serious in the United States,” Marks said. “Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.”
If the FDA authorizes Novavax as the nation’s fourth vaccine, it’s not clear how widely it would be used — at least right away. Only about 27 million U.S. adults remain unvaccinated. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines. The shots are used elsewhere as a booster, regardless of which vaccine people got originally.
Tuesday’s question: Do the benefits of two primary doses of the Novavax vaccine outweigh any risks? The FDA advisory panel voted that they do, by a 21-0 vote with one abstention.
Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. One complication: Those studies were done far earlier in the pandemic, well before more contagious coronavirus variants emerged — including the omicron mutant and its relatives.
Novavax chief medical officer Dr. Filip Dubovsky said the company already has tested a booster dose — and it revved up virus-fighting antibodies that could tackle that mutant.
This type of vaccine “we think generates a broad immune response against a broad array of variants,” he told the FDA advisory panel.
And while the trials showed generally people experienced only mild reactions such as injection-site pain or fatigue, the FDA did highlight a possible concern: six cases of heart inflammation, known as myocarditis, found among the 40,000 people who received the vaccine in studies.
Vaccines are coming under close scrutiny for the possibility of that heart inflammation after the Pfizer and Moderna shots were linked to that rare risk.
Novavax argued there were other potential causes for some of the cases in its trials. COVID-19, as well as other infections, also can cause heart inflammation. The company said more than 744,000 vaccinations in other countries so far support the shots’ safety.
The Novavax vaccine is made of copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.
Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.
That’s very different than the vaccines currently used in the U.S. The most widely used Pfizer and Moderna vaccines deliver genetic instructions for the body to produce its own copies of the spike protein. J&J; uses a cold virus to deliver those instructions.
Manufacturing problems held up Novavax’s vaccine but the company said those problems have been resolved. Novavax, a small biotech company, created the vaccine in its research lab, but the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots including those slated for the U.S.
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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.
Total Doses Distributed = 752,083,155. Total Doses Administered = 589,654,645. Number of People Receiving 1 or More Doses = 258,865,995. Number of People Fully Vaccinated = 221,559,553.
The European Union’s chief executive vowed Tuesday that Poland would get no money from the bloc’s vast pandemic relief fund until the right-wing government rolls back measures deemed to limit the independence of the country’s judiciary.
Poland is line to receive nearly 36 billion euros ($38.5 billion) to help its economy recover from the impact of measures introduced to limit the spread of the coronavirus. But the EU has frozen its access to the funds amid concern about political interference with the judiciary.
The European Commission, which proposes EU laws and supervises the way they are enacted, insists that a disciplinary chamber for Polish judges be abolished, that its rulebook be rewritten and that judges sanctioned by the chamber have their cases reviewed.
“Let me be very clear. These three commitments, translated into milestones, must be fulfilled before any payment can be made,” European Commission President Ursula von der Leyen told EU lawmakers in Strasbourg, France.
The European Parliament has also launched action against Poland over democratic backsliding. The lawmakers have criticized von der Leyen and her commission for being too slow to act. Some are calling for a no-confidence vote on her should the commission release any funds too early.
“I know that some of you are skeptical, but let me assure that no money will be disbursed until these reforms are undertaken,” von der Leyen said. “A first payment will only be possible when a new law is in force that ticks all the boxes under this contract,” she said of a plan for Poland to access the funds.
Von der Leyen added that “Poland must demonstrate by the end of 2023 that all unlawfully dismissed judges have been reinstated. If this is not the case there cannot be any further disbursement.”
Poland’s lawmakers are still working on changing Supreme Court regulations to abolish the disciplinary chamber. Only one of the dozens of suspended judges has been reinstated, but to a different section in his court, and has been ordered to go on leave.
Many EU lawmakers argued that Poland should have met the conditions before its action plan for access to the recovery fund was submitted. Even some senior members of von der Leyen’s own commission had reservations about the Polish plan.
Dutch liberal parliamentarian, Sophia In’t Veld, said the commission’s conditions are merely “a smokescreen.” Facing von der Leyen, she said: “If you make any payment to Poland without all the criteria having been fully met, you lose my confidence. It’s democracy.”
Poland’s pandemic recovery plan must still be endorsed by the other 26 EU member states before the end of the month. It would pave the way for government to eventually gain access to 23.9 billion euros ($25.4 billion) in grants and 11.5 billion euros ($11.7 billion) in loans.
EU officials have said that Poland is unlikely to win access to any of the money for several months.
Health workers protested Tuesday around France to demand more hiring and better salaries in public hospitals, after years of cost cuts that left medics submerged when the COVID-19 pandemic hit and are now forcing emergency rooms to cut services.
Nine unions and collectives organized a day of protest, including a demonstration outside the Health Ministry in Paris and in dozens of other towns and cities, to call the government’s attention to growing concerns about staff shortages.
President Emmanuel Macron has promised a rethink of the public hospital system and commissioned an urgent review by July 1. Protesters hope to pressure the government as France heads into two rounds of legislative elections starting Sunday.
“We need an emergency plan for public hospitals today, with massive hiring … We also want a pay rise. We are the least paid in Europe,” said Nathalie Marchand, a personnel assistant at Paris’ Saint Louis hospital.
She was among several hundred health workers who demonstrated outside the Health Ministry.
Demonstrations were held elsewhere in France, including in Cherbourg, where Macron visited a hospital last week to announce his “flash mission” to work to bolster saturated emergency services.
“How could Emmanuel Macron, call an urgent review when there have been shortages for so long?” said Rachid Ouchem, a psychological assistant.
Ouchem is among those who would like to see the rehiring of around 15,000 health workers who lost their jobs for refusing to get vaccinated against COVID-19, saying it would be an immediate answer to the long process of eventually training new hospital staff.
Macron’s government offered slight salary boosts to some hospital workers last year and authorized new equipment, but medics say the problems are deeper. Years of gradual cost cuts left France’s once-renowned public health care system understaffed and ill-prepared when the pandemic hit. Morale was already low among many medics, and some have quit the profession. Others are still reeling from the challenges of treating successive waves of COVID-19 patients.
An emergency medics’ group, Samu-Urgences de France, calculated last month that more than 100 emergency facilities have either already limited services are plan to because of staff shortages.
Despite the crisis situation, the Paris demonstration failed to attract huge throngs of protesters.
“The public hospital is the common good,” said Ouchem, encouraging health professionals and others to mobilize. “Anybody could be at the hospital or in an ER tomorrow.”
He added, “For two years, hospitals only stand thanks to health workers.”
