Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.
Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public health precautions — even though highly contagious coronavirus mutants continue to spread.
Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers — albeit not as effectively during the omicron surge as earlier in the pandemic.
“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that.”
Now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.
Whether it’s one company’s shots or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding if tot-sized doses are safe and effective.
While questions are swirling about what’s taking so long, Marks pointedly told lawmakers this week that the FDA can’t evaluate a product until a manufacturer completes its application. FDA will publicly debate the evidence with its scientific advisers before making a decision, and Marks said multiple meetings would be set to cover several expected applications.
“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” Marks told a Senate committee.
If FDA clears vaccinations for the littlest, next the Centers for Disease Control and Prevention would have to recommend who needs them — all tots or just those at higher risk from COVID-19.
Many parents are desperate for whichever vaccine gets to the scientific finish line first.
“We’ve been kind of left behind as everybody else moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose 6-year-old daughter is vaccinated — but whose 3-year-old and 18-month-old sons are part of Pfizer’s trial.
The family continues to mask and take other precautions until it’s clear if the boys got real vaccine or dummy shots. If it turns out they weren’t protected in the Pfizer study and Moderna’s shots are cleared first, Dunphy-Daly said she’d seek them for her sons.
“I will feel such a sense of relief when I know my boys are vaccinated and that the risk of them getting a serious infection is so low,” she said.
Some parents even have urged the government to let families choose shots before all the evidence is in.
“This strain of COVID feels almost impossible to dodge,” Dana Walker, a mother of an 8-month-old, tearfully told a CDC meeting last week. “Cut red tape and allow parents to protect their kids.”
The FDA will face some complex questions.
In a study of kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults, Burton said. There were no serious side effects, and the shots triggered fewer fevers than other routine vaccinations.
But the vaccine proved between about 40% and 50% effective at preventing symptomatic COVID-19 during the trial. Burton blamed the omicron variant’s ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.
Another issue: So far in the U.S., Moderna’s vaccine is restricted to adults. Other countries have expanded the shot to kids as young as 6. But months ago the FDA cited concern about a rare side effect, heart inflammation, in teen boys, and it hasn’t ruled on Moderna’s earlier pediatric applications.
Burton said the FDA may consider its vaccine for children of all ages — but also might open it first to the youngest kids who have no other option. He said safety data from millions of older children given Moderna vaccinations abroad should help reassure parents.
While COVID-19 generally isn’t as dangerous in youngsters as adults, some do become severely ill or even die. About 475 children younger than 5 have died from COVID-19 since the pandemic’s start, according to the CDC, and child hospitalizations soared at omicron’s peak.
Yet it’s not clear how many parents intend to vaccinate the youngest kids. Less than a third of children ages 5 to 11 have had two vaccinations, and 58% of those ages 12 to 17.
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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.
Taiwan, which had been living mostly free of COVID-19, is now facing its worst outbreak since the beginning of the pandemic with over 11,000 new cases reported Thursday.
Cases have been on the upswing since late March. In April, the island’s central authorities announced that they would no longer maintain a “zero-COVID” policy like the Chinese government’s in which they would centrally quarantine positive cases.
Instead, the government is asking people to quarantine at home if they test positive, unless they show moderate to severe symptoms.
Chen Shih-chung, the island’s health minister, announced Thursday they had found 11,353 new cases, along with two deaths. During the daily press briefing held by the Central Epidemic Command Center, he said 99.7% of the cases in the current outbreak either had no symptoms or had mild symptoms.
Most of Taiwan’s 858 COVID-19 deaths came from summer 2021. Until this month, it had been the island’s one major outbreak in the pandemic.
Taiwan has been relatively lucky throughout the pandemic, but also has maintained strict border controls with a two-week quarantine on arrival required for all visitors.
Domestically, mask wearing is universal both outdoors and indoors. Masks are legally required on public transportation and in places like shops and theaters.
In the past few weeks, as cases have ratcheted up, people scrambled to buy up rapid tests with stores selling out in just a few hours. Convenience stores across Taipei were unsure where their next delivery would come from.
Difficulty buying rapid tests is likely due in part to the government’s thought throughout the pandemic that there are few benefits to mass testing. The health minister last year said that public funds and medical resources could better be used elsewhere.
The central government this month said it would work with Taiwanese companies who manufacture tests to ensure that everyone would have access. A system was rolled out Thursday that limits each person to buying one pack of five tests per trip. Each purchase must be linked to an individual’s national ID to ensure that there is no stockpiling.
Experts are worried about the 5 million people who have not been fully vaccinated against COVID-19.
Those who did not complete a full vaccination course are four times more likely to get moderate or severe symptoms compared to those those who have gotten a booster, said Ho Mei-Shang, a vaccine expert in Taiwan who has also worked for the U.S. Centers for Disease Control and Prevention, according to Central News Agency.
Most vulnerable in Taiwan’s outbreak this time are children and the elderly. The vaccination rate among people over 75 is 72.5%. However, only 59.1% in the same age group received a booster.
Society’s youngest are also not protected. Some schools have switched back to remote learning based on the number of positive cases each school is reporting. The island is opening up vaccine shots to children ages 6-11 next week.
A 2-year-old boy in New Taipei City died last week, the youngest victim of COVID-19 in Taiwan. His condition deteriorated rapidly after testing positive in a rare case.
Still, officials urged the public to not panic, saying that Taiwan was better prepared with vaccines and ways to ensure moderate and severe cases would get prompt attention.
“We want to tell the public, from the medical world, please rest assured,” said Chiu Tai-yuan, a lawmaker who also heads the Taiwan Medical Association. “Last year’s outbreak situation is not like the one we face today.”
Total Doses Distributed = 724,696,315. Total Doses Administered = 574,232,736. Number of People Receiving 1 or More Doses = 257,423,254. Number of People Fully Vaccinated = 219,483,386.
Colombians will soon be going to movie theaters without having to wear face masks. Chile opens its borders next week for the first time in two years. Mexico’s president has declared the pandemic over. And in Rio de Janeiro, tens of thousands attended Carnival parades just two months after the world-famous spectacle was postponed to prevent COVID-19 infections.
Even as coronavirus cases rise half a world away in China and authorities there impose new lockdowns, plummeting infection rates in Latin America have countries eliminating restrictions on mass gatherings, lifting some travel requirements and scrapping mask mandates that have been in place for two years.
The region has been hit hard by the pandemic, with nations like Brazil and Peru registering some of the world’s highest death tolls. But cases and deaths fell this month in most places to lows resembling levels last seen in the first two months of the pandemic.
Some epidemiologists believe vaccination campaigns and months of exposure to different strains of the virus have helped the region’s populations resist new waves of contagion.
“What we appear to be seeing is that while the virus is still circulating, many people are not falling ill or presenting symptoms,” said Fernando de la Hoz, an epidemiology professor at the National University in Bogota, Colombia’s capital.
Last year Latin American countries were pummeled by the coronavirus, with the Delta and Gamma variants — the latter of which emerged in Brazil — infecting millions and killing hundreds of thousands.
In June, Brazil reached 500,000 deaths and seven countries in South America were among the 10 nations in the world with the highest death rates per capita.
Peru is now the only Latin American nation still to have that dubious distinction, according to data compiled by Statista, a market research platform. But even in Peru, COVID-19 deaths have fallen dramatically, from more than 200 a day in February to around 20 by the end of April. Coronavirus intensive care units, packed a year ago, were at just 11% of capacity at the beginning of this month according to the Ministry of Health.
The BA.2 variant of the virus, which spread rapidly through China, the United States and some European countries in March, has not had a significant impact in most of the region so far.
In Colombia, cases are down from 35,000 per day in mid-January, when the omicron variant peaked, to around 250 per day. Daily deaths are in the single digits, and as of the first week of April, just 177 of a total of 10,700 ICU beds were occupied by coronavirus patients, according to the Pan American Health Organization.
“We don’t expect that wave from China to arrive here because our strategy has been different to theirs,” Martha Lucía Ospina, the director of Colombia’s National Health Institute, told radio station La FM this month.
“They shut down contact with the outside world as they aimed for a zero Covid strategy … while we opened up gradually and applied different kinds of vaccines that have generated an interesting mix of immunity,” Ospina said.
Most countries in the region have met the World Health Organization’s target of vaccinating 70% of their people with at least two doses.
As case numbers and hospitalizations fall away, so do many restrictions on social life.
Brazil’s federal government revoked a 2020 measure that declared the pandemic a health emergency, and many states have eased mask mandates and other constraints.
Masks were not required last weekend at the packed Sambadrome, Rio’s Carnival parade ground, which can hold more than 60,000 spectators. Vaccination cards were supposedly a condition for entry, but people had no trouble getting in without them. After being suspended in February, the celebrations were moved to an April holiday.
Colombia’s government announced that starting May 1, masks will no longer be needed at shopping malls, cinemas and other large indoor venues in cities with vaccination rates of at least 70%.
Argentina lifted all travel restrictions in March including for unvaccinated people, and Buenos Aires, the capital, no longer requires masks in any venues.
In Central America, El Salvador stopped requiring them in public spaces as of April 21st.
Masks are also no longer mandatory in most places in Mexico, which has seen daily cases fall from 40,000 in late January to 1,000 in mid-April. President Andrés Manuel López Obrador said this week that the country had entered a “new stage” in which the virus will have seasonal variations.
There is at least one place where infections are rising: In Puerto Rico, cases rebounded after mask requirements and caps on attendance in public venues were lifted March 10, prompting the island’s government this month to once again mandate masks at large events.
The island surpassed 3,000 cases a day this week, according to Johns Hopkins University, up from about 200 per day during the first week of March.
Iván Darío Vélez, a specialist in infectious diseases at Colombia’s University of Antioquia, said new mutations and outbreaks can still happen in the coming months, and governments in the region may have to apply new rounds of vaccinations or take other steps.
“This virus is very unpredictable,” he added. “Governments will have to monitor its behavior closely and take appropriate measures.”
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Associated Press writers David Biller in Rio de Janeiro; Almudena Calatrava in Buenos Aires, Argentina; Dánica Coto in San Juan, Puerto Rico; Eva Vergara in Santiago, Chile; Franklin Briceño in Lima, Peru; Marcos Alemán in San Salvador, El Salvador; and María Verza in Mexico City contributed to this report.
A British court ruled Wednesday that the government’s decision to discharge hospital patients into nursing homes without testing them for COVID-19, which led to thousands of deaths early in the pandemic, was illegal.
Two High Court judges said the policy from March and April 2020 was unlawful because it failed to take into account the infection risk that non-symptomatic carriers of the virus posed to older or vulnerable people.
The judges said officials did not consider other options, including keeping such patients separate from other nursing home residents for a time as much as practically possible.
“This was not a binary question – a choice between on the one hand doing nothing at all, and on the other hand requiring all newly admitted residents to be quarantined,” the judges said.
The ruling came in response to a lawsuit by two women whose fathers died when the virus swept through the homes where they lived. Their lawyers said the decisions that allowed COVID-19 to spread among the elderly and vulnerable was “one of the most egregious and devastating policy failures in the modern era.”
The judges backed some parts of the lawsuit’s arguments but rejected claims made under human rights legislation and against the National Health Service.
Prime Minister Boris Johnson said the government would study the ruling and respond “in due course.”
He said officials had to make difficult decisions at an “incredibly difficult time” when “we didn’t know very much about the disease.”
“The thing we didn’t know in particular was that COVID could be transmitted asymptomatically in the way that it was, and that was something that I wish we had known more about at the time,” Johnson said in the House of Commons.
“Of course, I want to renew my apologies and sympathies for all those who lost loved ones during the pandemic, people who lost loved ones in care homes,” he added.
Like many countries, the U.K. had little capacity to test for the coronavirus when the pandemic began, and many asymptomatic patients were released from hospitals back into care homes, where COVID-19 soon ran riot.
Around 20,000 people died with the virus in British nursing homes during the initial months of the country’s first outbreak in 2020.
The health secretary at the time, Matt Hancock, has said the government did all it could to keep people safe during the biggest public health crisis in decades.
Hancock’s office said in a statement that the court ruling cleared him of wrongdoing and found he “acted reasonably on all counts.” It said Hancock — who quit the government last year after it was revealed he breached pandemic social-distancing rules by having an affair while living with his wife — wished health officials had told him sooner all they knew about asymptomatic transmission of the virus.
Claimant Cathy Gardner, whose father died in April 2020, said “my father and other residents of care homes were neglected and let down by the government.”
“Matt Hancock’s claim that the government threw a protective ring round care homes in the first wave of the pandemic was nothing more than a despicable lie of which he ought to be ashamed and for which he ought to apologize,” Gardner said.
Johnson has set up an independent public inquiry into Britain’s handling of the pandemic, though it has yet to begin. More than 174,000 people have died in Britain after testing positive for the virus, the highest toll in Europe after Russia.
During the height of pandemic restrictions, thousands of New Zealanders desperate to return home essentially had to roll the dice month after month as they tried to secure a coveted bed in a quarantine hotel run by the military.
On Wednesday, a New Zealand court ruled that the government had breached the rights of its own citizens by imposing the lottery-style system on them.
A group called Grounded Kiwis had used crowdsourcing to help fund their case against the government.
But while they were celebrating their victory, the case may have little impact going forward as New Zealand has since abandoned its zero-tolerance approach to the virus and largely dismantled its contentious quarantine system.
Central to the case was New Zealand’s Bill of Rights Act, which guarantees every citizen the right to return home.
High Court Justice Jillian Mallon ruled that forcing people to stay in quarantine hotels for two weeks initially, and later for one week, was reasonable given the circumstances of the pandemic.
But she found that operating a lottery-style system for the beds was unreasonable, and did not take into account how long people had been waiting abroad, or whether they had a compelling need to return home.
“New Zealanders’ right to enter their country could be infringed in some instances in a manner that was not demonstrably justified in a free and democratic society,” the judge concluded.
The flaws in the system were highlighted earlier this year by the case of Charlotte Bellis, a pregnant New Zealand journalist who was temporarily stranded in Afghanistan due to New Zealand’s strict border policies.
The case quickly became an embarrassment to the New Zealand government, which backed down and offered Bellis a pathway home, which she accepted.
Paul Radich, a lawyer representing Grounded Kiwis, said he was “delighted” with the decision, which came as vindication for people who had faced huge difficulties returning home.
Opposition lawmaker Chris Bishop said the government’s Managed Isolation and Quarantine (MIQ) system had inflicted enormous suffering.
“We now have judicial confirmation of state-sponsored cruelty that was the MIQ lottery,” Bishop said.
“Pregnant women like journalist Charlotte Bellis were denied MIQ vouchers to enter New Zealand,” Bishop said. “People couldn’t return to be with loved ones in the final stages of their lives.”
But COVID-19 Response Minister Chris Hipkins said the court had confirmed that the MIQ system was lawful and justified. He said he acknowledged the court found that the rights of some citizens may have been breached by the lottery-type system for beds.
“We have long acknowledged the difficult trade-offs we’ve had to make in our COVID-19 response to save lives and the effects of those decisions on all New Zealanders, particularly those living abroad,” Hipkins said.
The court case specifically examined the so-called virtual lobby system, which was essentially a government-run lottery for quarantine spots, as it operated between early September and mid-December 2021.
New Zealand’s approach to the pandemic has changed markedly over time, which this year has led to the quarantine system being dismantled.
Until last October, the nation of 5 million pursued a zero-tolerance approach as the government led by Prime Minister Jacinda Ardern tried to eliminate the virus completely.
That gave way to a suppression strategy during an outbreak of the delta variant and then finally to something approaching acceptance as an outbreak of the omicron variant proved impossible to contain.
