The Latest: Moderna seeks full FDA approval for its vaccine
CAMBRIDGE, Mass. — American pharmaceutical company Moderna says it has begun the process to win full U.S. regulatory approval for the use of its COVID-19 vaccine in adults.
Moderna announced Tuesday it has begun a “rolling submission” to the Food and Drug Administration of data from its studies of the two-dose vaccine.
Moderna’s vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries. So far, more than 124 million doses have been administered in the United States.
Large-scale studies of the shots continued after Moderna’s emergency authorization. The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.
Moderna is the second COVID-19 vaccine maker to seek full approval, following Pfizer and German partner BioNTech.
Last week, Moderna also announced that its vaccine appears safe and effective in kids as young as 12. The company plans to seek emergency authorization for teen use this month.
MORE ON THE VIRUS OUTBREAK:
— Peru raises COVID-19 death toll sharply, up to over 180,000 from previous count of nearly 70,000
— Son’s grief, guilt become tribute honoring COVID-19 victims
— Japan’s vaccine push ahead of Olympics looks to be too late
— Businesses close in Malaysia’s second lockdown as surge puts health care system on verge of collapse
— Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
HERE’S WHAT ELSE IS HAPPENING:
BERLIN — German authorities are investigating allegations of fraud involving the massive rollout of free coronavirus tests, which are being carried out now in converted cellphone stores, beauticians and art galleries across the country.
Germans have to present a negative test result in order to enter non-essential stores, visit restaurants or bars, or attend small-scale cultural events. The government pays for one free test per person each week, which has led to a proliferation of more than 15,000 businesses offering antigen tests that provide results within 20 minutes.
“There is the suspicion, a very well-founded suspicion after everything I’ve seen, that there’s also been fraud,” Jens Spahn, the country’s health minister, said Tuesday.
The issue has once again raised questions of who is accounting for the German government’s spending splurge in response to the pandemic.
Last year, numerous applicants seeking government support for businesses affected by the lockdown were found to have made fraudulent claims, leading to a tightening of rules and severe delays in payments as further checks were conducted.
STOCKHOLM — Sweden took the first of in a five-step plan to reopen the country Tuesday, when restaurants, bars, cinemas and other venues were allowed to extend their hours.
“I love going to the movies, I used to go to the movies two or three times a week, so this year, it’s been very lonely,” retiree Gunilla Boding said as she was about to head inside a downtown Stockholm movie theater.
Sweden stood out among European nations last year for its comparatively hands-off response to the coronavirus. The government never ordered lockdowns or closed businesses, relying instead on citizens’ sense of civic duty to control outbreaks.
The Scandinavian country has reported more than 1 million cases and over 14,000 deaths since the beginning of the pandemic, far more per capita than Sweden’s Nordic neighbors but less than in most European countries that had nationwide lockdowns and curfews.
Along with allowing businesses to stay open longer, the number of people who can legally gather in Sweden will gradually increase in the coming months.
ROME— Italians may eat and drink indoors at bars and restaurants for the first time in months, and that includes the morning ritual of having an espresso or cappuccino at a local cafe.
Until Tuesday, businesses had to either offer outdoor seating, or serve coffee in takeaway cups, admonishing customers to step away from the bar before sipping or run afoul of virus restrictions.
Rome resident Paolo Leoni enjoyed an espresso at the Toraldo Cafe in the center of Rome. He said that “one coffee gives us the feeling of living serenely again.”
Cafe owner Alessandro Rappini says that seeing the place fill up again after four months “gives me a huge sense of satisfaction.”
Italy began rolling back pandemic restrictions in April as the number of new cases showed signs of steady decline. To date, nearly 35 million people in the country of 60 million residents have received at least one shot of a COVID-19 vaccine.
WARSAW, Poland — Government officials say Poland will begin offering vaccines against the coronavirus to children ages 12-15 next week.
The plans described on Tuesday came after the European Union’s drug regulator recommended Friday that the use of the vaccine made by Pfizer and BioNTech be expanded to that age group.
The Polish government also said that people could start accessing COVID-19 travel certificates online starting Tuesday, a plan the EU agreed on to ease summer travel. It involves providing a certificate to EU residents who can prove they have been vaccinated, tested negative for the virus or recovered from COVID-19, allowing them to avoid quarantines.
Michal Dworczyk, who heads the government’s vaccination program, said vaccines for younger adolescents would begin on June 7. Education Minister Przemysław Czarnek said the government also plans to carry out a school vaccination programs in the fall to encourage families to get shots for older children.
He said that vaccinations for children, as for adults, would be voluntary.
LONDON — London’s Heathrow Airport has reopened a terminal that was mothballed during the coronavirus pandemic to handle passengers now arriving from high-risk countries. Critics say the action should have been taken sooner.
Britain has barred travelers from a “red list” of 43 coronavirus hotspots including India, Brazil and Turkey. U.K. nationals and residents returning from those countries face a mandatory 10-day quarantine in a hotel. Other travelers coming from “amber list” countries like the United States can do their mandatory 10-day quarantine at home in the U.K.
Critics have complained that red list passengers have been using the same massive airport arrivals hall as travelers from other destinations, though in separate lines, since the hotel quarantines were introduced in February.
Starting Tuesday, red list arrivals will pass through the airport’s Terminal 3, which was closed in April 2020 as international air travel plummeted.
BERLIN — Germany’s health minister says the coronavirus risk level in the country is being downgraded from very high to high.
Minister Jens Spahn said Tuesday that the risk level was last raised on Dec. 11, but successful efforts to curb the spread of the virus have now allowed that step to be reversed.
The decision reflects the decline in new weekly cases, which now stands about 35 per 100,000 inhabitants nationwide.
Out of 412 German counties and cities, only four currently have a rate of more than 100 newly confirmed cases per 100,000 inhabitants in the past week, a threshold that triggers tougher pandemic restrictions.
The Robert Koch Institute said it received reports of 1,785 newly confirmed COVID-19 cases Monday and 153 more deaths. Germany has reported over 86,000 COVID-19 deaths.
CANBERRA, Australia — An Australian court has rejected a challenge to the federal government’s draconian power to prevent most citizens from leaving the country so they don’t bring the coronavirus home.
Most Australians have been stranded in their home nation for more than a year under a government emergency order made under the powerful Biosecurity Act. Australia is alone among developed democracies in preventing its citizens and permanent residents from leaving the country during the pandemic except in “exceptional circumstances.”
The libertarian group LibertyWorks argued the government dids not have the power to enforce the travel ban.
But the three judges ruled for the government Tuesday. They said Parliament knew the law’s impact would be harsh when it passed the Biosecurity Act in 2015.
BEIJING — China’s southern manufacturing hub of Guangzhou has imposed lockdowns on two neighborhoods after an additional 11 cases of COVID-19 were detected in the city.
The surrounding province of Guangdong has already required anyone wishing to travel to other parts of China produce a negative test for the virus taken within the previous 72 hours.
Guangzhou has 15 million people but it wasn’t immediately clear how many people were affected by the lockdowns announced on Tuesday.
More than 30 cases of local transmission have been detected in the city over recent days, making it the latest virus hotspot in a country that has mostly eliminated domestic infections through mask mandates, strict case tracing, widespread testing and strict lockdowns when cases are detected.
COLOMBO, Sri Lanka — Sri Lanka eased restrictions on air travel and reopened the airports for inbound passengers on Tuesday, after a 10-day suspension to try to contain the spread of the coronavirus.
The Civil Aviation Authority of Sri Lanka said each incoming flight could carry only a maximum of 75 passengers and all must quarantine for 14 days. Any passenger with a travel history to India or Vietnam in the past 14 days cannot disembark in Sri Lanka.
Sri Lanka did not permit to disembark passengers at its two main international airports from May 21 until Monday, but allowed departures, freighter operations and humanitarian flights.
Travel restrictions remain in place across the country, banning people from leaving their houses through next Monday as health workers are grappling with a highly infectious variant that has caused infections to surge since April.
By Tuesday, the number of cases in Sri Lanka rose to 186,363 with 1,487 fatalities.
GENEVA — The World Health Organization is announcing a new nomenclature for the COVID-19 variants that were previously — and somewhat uncomfortably — known either by their technical letter-number codes or by the countries in which they first appeared.
Hoping to strike a fair and more comprehensible balance, WHO said it will now refer to the most worrisome variants — known as “variants of concern” — by letters in the Greek alphabet.
So the first such variant of concern, which first appeared in Britain and can be also known as B.1.1.7, will be known as the “alpha” variant. The second, which turned up in South Africa and has been referred to as B.1.351, will be known as the “beta” variant.
A third that first appeared in Brazil will be called the “gamma” variant and a fourth that first turned up in India the “delta” variant. Future variants that rise to “of concern” status will be labeled with subsequent letters in the Greek alphabet.
WHO said a group of experts came up with the new system, which will not replace scientific naming systems but will offer “simple, easy to say and remember labels” for variants.
LOS ANGELES — Californians headed to campgrounds, beaches and restaurants over the long Memorial Day weekend as the state prepared to shed some of its coronavirus rules.
Southern California beaches have been busy with families barbecuing and children playing in the sand and surf. Business owners say they’re scrambling to hire workers to keep up with the customer demand since virus cases have fallen and vaccinations have risen.
The surge in travel and recreation comes as California prepares to relax social distancing and masking rules June 15 if coronavirus cases remain low. Newly reported infections in the state have fallen below 1,000 on some days. The positivity rate has been 1%.
LIMA, Peru — Peru announced a sharp increase in its COVID-19 death toll, disclosing more than 180,000 fatalities since the pandemic began.
The announcement was made in the presidential palace during the presentation of a report by a working group commissioned to analyze and update the death toll. The results of the study put the new toll at 180,764 in a population of about 32.6 million, compared to recent data indicating that 69,342 people had died from COVID-19.
Health Minister Oscar Ugarte said the criteria for identifying the coronavirus as a cause of death were changed. Previously, only those who “had a positive diagnostic test” were considered to have died from the virus, but other criteria have since been incorporated.
The new toll from COVID-19 includes deaths reported between March 2020 and May 22 of this year. Among Latin American countries, only Brazil and Mexico have reported higher death tolls from the disease.
On Monday, the coronavirus monitoring site of Johns Hopkins University was reflecting the previous figure of just under 70,000 deaths in Peru. Questions about Peru’s death toll surfaced soon after the beginning of the pandemic.
ANKARA, Turkey — Turkey is further easing its COVID-19 restrictions, including relaxing its night-time and weekend curfews, following a decline in infections.
Turkish President Recep Tayyip Erdogan said restaurants and cafes, which were only able to open for delivery or take-away, would be allowed to accept sitting customers until 9 p.m. beginning Tuesday. Businesses such as gyms and amusement parks can reopen until 9 p.m.
The night-time curfews was pushed back by an hour, to start at 10 p.m. Erdogan said Sunday curfews are to remain in place but people will be free to leave their houses on Saturdays. Civil servants will continue working remotely or in shifts in offices.
Meanwhile, the education minister said primary and secondary school students would return to their classes for in-person education two times a week. In less populous towns and villages, schools would reopen full time.
Earlier this month, the number of daily COVID-19 infections dropped to below 10,000 for the first time since March 1, after reaching a record-high of more than 63,000 daily cases in mid-April.
On Monday, the Health Ministry posted 6,933 new cases and 122 deaths, raising the overall death toll to 47,527.