NEW YORK — Drugmaker Pfizer has begun the process to earn full U.S. regulatory approval for its COVID-19 vaccine for people aged 16 and older.
That gives Pfizer and German partner BioNTech a shot at winning the first full approval from the U.S. Food and Drug Administration.
The two companies say they’ve started a “rolling submission” of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing. That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose. The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.
Pfizer Chief Executive Albert Bourla said in a statement that the companies are aiming to win full regulatory approval “in the coming months.”
The shot received emergency use authorization from the FDA on Dec. 11. Since then, the companies have delivered more than 170 million doses across the U.S., and many more to other countries that also have authorized emergency use amid the coronavirus pandemic. Such emergency authorizations only last until countries declare an end to the emergency, so the vaccine must undergo a more stringent review by regulators to earn full approval for continued use.
Dr. Ugur Sahin, co-founder of BioNTech, said the submission “is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”
The partners also applied to the FDA to expand the current emergency authorization to people ages 12 to 15. They plan to seek full approval for that age group once they have the required six months of follow-up data from the volunteers tested in that group. They’re also testing the shot in younger children and pregnant women.
THE VIRUS OUTBREAK:
— India cases hit new record as calls grow for strict lockdown
— Japanese impatient over virus steps; state of emergency extended in Tokyo
— WHO panel to decide on emergency use of Chinese vaccine
— Doctors in Nepal warn of major crisis as virus cases surge
Follow more of (DailyNews)’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
HERE’S WHAT ELSE IS H(DailyNews)PENING:
LONDON — Britain says a coronavirus strain first identified in India has been labelled a “variant of concern” because it appears be more transmissible than some other variants.
Public Health England says the number of cases of the B.1.617.2 variant identified in the U.K. has increased from 202 to 520 in the past week. The majority are in northwest England and London and just over half the cases haven’t been linked to travel to India.
Health authorities say there is “insufficient evidence” so far to say whether the variant causes more severe disease or is resistant to vaccines. But they say it appears more transmissible than the original strain of the virus.
Prime Minister Boris Johnson says authorities were being “very careful” about the new strain and door-to-door “surge testing” will be carried out in areas where it was spreading.
Strains first identified in South Africa and Brazil have been designated variants of concern. The variant first identified in southeast England last year was the first to be called a “variant of concern.” It is now the dominant variant in the U.K.
However, coronavirus cases in Britain have gone down significantly since a lockdown in January, and restrictions are gradually easing. Schools, hair salons and shops are open, along with restaurants and pubs operating outdoors.
TOKYO — Japan extended its state of emergency in Tokyo and other areas through May 31.
Japan is showing social and political strains as the coronavirus spreads ahead of the Tokyo Olympics, which start in 11 weeks.
Tokyo logged 907 new cases of coronavirus infections, up sharply from 635 when the state of emergency began in the capital last month. It’s far above the target of 100 that some health experts recommend.
Most Japanese oppose hosting the Olympics during a pandemic, while the government seems determined to hold the event. However, people are growing impatient and less cooperative, which could make the measures less effective.
The president of the Tokyo Olympics organizing committee, Seiko Hashimoto, says a possible mid-May visit by International Olympic Committee President Thomas Bach has become more difficult because of the extension of the emergency. The postponed Olympics from last year are scheduled for July 23-Aug. 8.
(This item has been corrected to show Seiko Hashimoto is the president of the Tokyo Olympics. She was formerly the minister of the Olympics.)
LONDON — Britain’s vaccines regulator says people under 40 shouldn’t be given the AstraZeneca coronavirus vaccine if another shot is available because of a suspected link to very rare blood clots.
The Joint Committee on Vaccination and Immunization says people ages 30 to 39 without underlying health conditions should receive an alternative vaccine, “where available and only if this does not cause substantial delays in being vaccinated.”
Last month it gave the same advice for people under 30. Two-thirds of U.K. adults have received at least one shot of vaccine, and almost a third have had both doses. A majority have had the AstraZeneca shot, though Britain is also using vaccines made by Moderna and Pfizer-BioNTech.
British health officials say the risk from COVID-19 far exceeds any risk from the AstraZeneca vaccine for the vast majority of people.Up to April 28, Britain’s medicines regulator had received 242 reports of blood clots accompanied by low blood platelet count in people who had received the AstraZeneca vaccine, out of 28.5 million doses given. There were 49 deaths.
Most of the cases occurred after the first dose, and the vaccination watchdog says there are no concerns about people getting second AstraZeneca shots.
LONDON — The European Medicines Agency said the product information for the COVID-19 vaccine made by BioNTech and Pfizer should be modified to make doctors and patients aware that people who have previously had dermal injections could experience facial swelling after getting a dose.
The EU drug regulator says it had reviewed all available evidence and concluded that “there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers.” It described dermal injections as “soft, gel-like substances injected under the skin.”
The EMA recommended facial swelling be added as a potential side effect but that its assessment of the vaccine remained unchanged and the benefits outweighed the risks.
LONDON — The European Medicines Agency says it has begun an accelerated authorization process for an experimental coronavirus treatment made by GlaxoSmithKline and Vir BioTechnology.
In a statement on Friday, the EU drug regulator said it had started a rolling review of sotrovimab, based on early results from an ongoing study into whether the treatment can prevent hospitalization or death in people who don’t yet have severe COVID-19. But EMA said it had not yet received the complete data and cautioned that “it is too early to draw any conclusions about the benefit-risk balance of the medication.”
Although the EMA has given the green light to four vaccines, there are few licensed treatments for the coronavirus, especially any that might prevent people with mild COVID-19 from progressing to severe disease.
Sotrovimab is a monoclonal antibody, a lab-produced antibody that is intended to stimulate the immune system by reducing the ability of the coronavirus’s spike protein to enter the body’s cells.
An emergency use authorization for sotrovimab has also been submitted to regulators in the U.S. and Canada.
ROME — The head of the World Trade Organization says the U.S. administration’s call to remove patent protections on COVID-19 vaccines will give an impetus to negotiations to resolve access inequity but that the decision in and of itself won’t resolve the problem.
WTO Director-General Ngozi Okonjo-Iweala told a virtual conference Friday that the WTO was aiming to find a “pragmatic solution that assures access to developing countries to deal with vaccine inequity, whilst at the same time making sure we don’t disincentivize research and innovation.”
In remarks to the Florence-based European University Institute’s annual State of the Union conference, Okonjo-Iweala, a Nigerian economist, said the patent waiver “may not be the critical issue” on increasing vaccine volume.
Other key steps include reducing export restrictions and prohibitions for both final products and raw materials, as well as training manufacturing personnel and increasing manufacturing capacity globally.
She noted that 80 percent of the world’s exports of vaccines is concentrated in 10 countries in North America, South Asia and Europe, and that Africa imports 99 percent of its vaccines. She said: “We are seeing the problems with that concentration now.”
THE HAGUE, Netherlands — Dutch authorities have seized the bank accounts of hundreds of businesses that are suspected of fraudulently claiming government coronavirus financial support.
The Netherlands Enterprise Agency announced Friday that prosecutors have filed cases against companies accusing them of abuse or dishonest use of a scheme in which the government contributes to rent payments and other recurring business costs.
It was not immediately clear how much money has been fraudulently claimed.
The enterprise agency says it has seized bank accounts as a way of clawing back wrongly claimed payments.
The Dutch government has pumped billions of euros into propping up companies ranging from national carrier KLM to small businesses that have been hit by the coronavirus and lockdown measures.
HONG KONG — Hong Kong health officials say quarantine rules for inoculated travelers arriving in Hong Kong from low- and medium-risk countries will be relaxed.
Inbound travelers who have been fully vaccinated from low-risk countries like Australia, New Zealand and Singapore will only need to undergo seven days quarantine in a hotel, down from 14 days previously. They will also need to take two coronavirus tests after their quarantine.
Those coming from medium-risk countries, such as Malaysia or Vietnam, will have their quarantines reduced to 14 days, from 21 days. Arrivals from high-risk countries, such as the U.S., Britain and other European countries like Germany or France will still have to undergo three weeks of quarantine, regardless of their vaccination status.
The new measures will take effect from May 12.
Hong Kong is seeking to boost its slower-than-expected vaccination rates in the city. Hong Kong has so far only vaccinated about 13.6% of its population, amid public distrust of the largely pro-Beijing government and concerns over side effects.
On Friday, officials also announced the reduction of quarantine periods for close contacts of coronavirus patients who have been fully vaccinated.
BERLIN — Germany’s health minister has welcomed a decline in new COVID-19 cases, but says Germans need to endure “weeks or a few months” of restrictions.
Germany’s seven-day rolling average of daily new cases declined over the past two weeks, from almost 25 cases per 100,000 people on April 22 to 19 cases per 100,000 people on May 6.
Health Minister Jens Spahn said Friday that efforts to reduce social contacts and travel had helped push down the number of infections in recent weeks.
He also cited the rapid increase in vaccinations in the country.
Spahn said about 26.2 million people, or about 31.5% of the German population, have received at least one dose of vaccine. Almost 9% have received two shots.
He warned against reopening some areas of public life too quickly however, warning that “this bears a risk.”
Some of Germany’s 16 states have begun allowing limited tourism and outside dining again.
Germany’s disease control agency reported 18,485 newly confirmed cases Thursday, and 284 deaths. Since the start of the outbreak, Germany has recorded almost 3.5 million confirmed cases and 84,410 deaths.
CANBERRA, Australia — Australia’s prime minister said on Friday an India travel ban will end with three government-chartered flights to repatriate Australians by the end of May.
The government has resisted mounting pressure to lift the travel ban imposed last week until May 15 to reduce infections in Australian quarantine facilities.
Prime Minister Scott Morrison said the 900 Australians listed as vulnerable would be given priority among the 9,000 citizens registered with authorities as wanting to come home from India.
But Australians would have to provide a negative result to a rapid antigen COVID-19 test before they could board a flight.
“I’m sure that’s what all Australians would expect,” Morrison said.
The flights would end at a quarantine facility outside the northern city of Darwin. The government had yet to make a decision on when normal commercial flights from India would resume.
TACOMA, Wash. – Washington Gov. Jay Inslee is receiving criticism from lawmakers in his own party over his shifting economic reopening plan, with a group of Democrats from the state’s second most populous county threatening the possibility of a special legislative session.
The lawmakers from Pierce County, south of Seattle, are upset that Inslee paused the plan that left their county stuck in a phase with tighter COVID-19 restrictions.
The letter, sent Thursday afternoon, was signed by eight Democrats in the House and Senate and four House Republicans. It comes the same day that the Washington Hospitality Association launched a petition to follow California’s lead and fully reopen the state on June 15.
Dozens of other states have already set plans to fully reopen their economies, include including New York and New Jersey, which have set a May 19 goal.
The letter states that while they don’t dispute the rising numbers in Pierce County that have only recently started to level out, the decision to pause Pierce and three other counties with more restrictions while allowing counties that were set to roll back to continue to have more business activity “damages both our confidence and communities.”
TOPEKA, Kan. — Kansas has requested less than 9% of its federal allocation of COVID-19 vaccine doses for this week, as Republican state lawmakers try to revive proposals to ban government vaccine passports and restore limits on tracing the close contacts of people exposed to the virus.
Democratic Gov. Laura Kelly’s office said Thursday that the state asked for fewer than 14,000 vaccine doses for the week, out of a federal allotment of almost 162,000. While the state sought its full allotment of 6,400 doses of a one-shot vaccine made by Johnson & Johnson, it requested only 7,510 doses of its allocation of 155,540 doses of two-shot vaccines manufactured by Pfizer and Moderna.
Kansas has seen its vaccination rate slow in recent weeks. It peaked at an average of 29,380 shots a day for the seven days ending April 6 and averaged only 11,872 for the seven days ending Wednesday, according to state Department of Health and Environment data.
Counties have been turning down vaccine doses as demand has waned, and while the department reported that more than 1.95 million shots had been administered as of Wednesday, there still were almost 647,000 more doses available. The health department in Sedgwick County, home to the state’s largest city of Wichita, has reduced the operations of its vaccine clinic by 10 hours a week because of falling demand, The Wichita Eagle reported.
NEW YORK — New York City wants to begin offering coronavirus inoculations to tourists by stationing vaccination vans at Times Square and other attractions, Mayor Bill de Blasio said Thursday.
The city needs state approval to vaccinate visitors and hopes to get an OK as soon as this weekend. The state Health Department didn’t immediately comment on the proposal.
De Blasio called it “a positive message to tourists: ‘Come here. It’s safe, it’s a great place to be and we’re going to take care of you.’”
“It’s a show of goodwill. It’s a welcome,” but not a requirement, the Democratic mayor said. He said the city has no plans to track tourists’ vaccination status.
Besides Times Square, the vans would appear in such places as Central Park, Brooklyn Bridge Park and the High Line elevated park, de Blasio said. Visitors would get the one-dose Johnson & Johnson vaccine, so they wouldn’t have to follow up with a second shot.
CHICAGO — Illinois will further lift coronavirus pandemic restrictions this month including increasing capacity limits at museums, events and gyms.
Gov. J.B. Pritzker said Thursday that the changes will start May 14 with the goal of full reopening next month if cases continue to decline.
Capacity at museums, theaters, gyms, offices and stores will be increased to 60% from 50% currently. Pritzker says the light at the end of the tunnel is getting brighter.
The Illinois Department of Public Health reported 1,778 new COVID-19 cases, which is the the lowest in several weeks.
SAO PAULO — Brazil’s health minister Marcelo Queiroga on Thursday said that he is concerned about the possibility of waiving intellectual property rules for COVID-19 vaccines, as it could jeopardize efforts to purchase vaccines from pharmaceutical companies.
“My fear is that we do not have the conditions, even after waiving (restrictions), to produce these vaccines here in Brazil,” Queiroga said in testimony during the Senate’s investigation into the government’s pandemic response. “Our program is based on vaccines like Pfizer’s and Janssen’s, and that (would) interfere in a negative way with the purchase of vaccines for the national immunization program.”