Pfizer and the German company BioNTech have become the first companies to apply to the US Food and Drug Administration for full approval of their Covid-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in America under an emergency use authorization granted in December.
The approval process is likely to take months.
The companies said in a statement on Friday that they had submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the FDA. They plan to submit additional material, including information about the manufacturing of the vaccine, in the coming weeks.
As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.
It could also make it easier for companies, government agencies, and schools to require vaccinations. The Equal Employment Opportunity Commission said in December that employers could mandate vaccination, and legal experts have generally agreed.
Many companies have been hesitant to require the vaccines, especially while they have only emergency authorization, which is designed to be temporary. Some institutions, like the University of California and California State University systems, have said that they would do so only after a vaccine has full approval.
Full approval could also prompt the US military, which has had low uptake of Covid-19 vaccines, to mandate vaccinations for service members.
The agency is also expected to issue an emergency authorization for use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds next week. The companies have said that they plan to file for emergency authorization for 2- to 11-year-olds in September.
Moderna plans to apply for full approval for its Covid-19 vaccine this month, the company said during its quarterly earnings call on Thursday. (New York Times)
CDC stresses airborne transmission
Federal health officials on Friday updated public guidance about how the coronavirus spreads, emphasizing that transmission occurs by inhaling very fine respiratory droplets and aerosolized particles, as well as through contact with sprayed droplets or touching contaminated hands to one’s mouth, nose, or eyes.
The Centers for Disease Control and Prevention now states explicitly — in large, bold lettering — that airborne virus can be inhaled even when one is more than six feet away from an infected individual. The new language, posted online, is a change from the agency’s previous position that most infections were acquired through “close contact, not airborne transmission.”
As the pandemic unfolded last year, infectious disease experts warned for months that both the CDC and the World Health Organization were overlooking research that strongly suggested the coronavirus traveled aloft in small, airborne particles. Several scientists on Friday welcomed the agency’s scrapping of the term “close contact,” which they criticized as vague and said did not necessarily capture the nuances of aerosol transmission.
The new focus underscores the need for the federal Occupational Safety and Health Administration to issue standards for employers to address potential hazards in the workplace, some experts said. (New York Times)
WHO to authorize Chinese firm’s vaccine
A World Health Organization panel announced Friday that it would authorize emergency use of a coronavirus vaccine made by Chinese firm Sinopharm.
The step means that the vaccine, developed by Sinopharm with the Beijing Institute of Biological Products, can be used to bolster WHO-backed efforts such as the Covax initiative to share doses equitably around the world.
It is also a major boost in international recognition for Sinopharm’s vaccine. It marks the first time that any Chinese-made vaccine received emergency authorization from the WHO.
Though the Sinopharm vaccine is already in widespread use around the world with an estimated 65 million doses administered, its developers have released only limited information about the vaccine’s efficiency and side effects. (Washington Post)
Indian PM pressed to institute lockdown
Indian Prime Minister Narendra Modi faced growing pressure Friday to impose a strict nationwide lockdown, despite the economic pain it will exact, as a startling surge in coronavirus cases that has pummeled the country’s health system shows no signs of abating.
Many medical experts, opposition leaders, and even Supreme Court judges are calling for national restrictions, arguing that a patchwork of state rules is insufficient to quell the rise in infections.
Indian television stations broadcast images of patients lying on stretchers outside hospitals waiting to be admitted, with hospital beds and critical oxygen in short supply. People infected with COVID-19 in villages are being treated in makeshift outdoor clinics, with IV drips hanging from trees.
As deaths soar, crematoriums and burial grounds have been swamped with bodies, and relatives often wait hours to perform the last rites for their loved ones.
Infections have swelled in India since February in a disastrous turn blamed on more contagious variants as well as government decisions to allow massive crowds to gather for religious festivals and political rallies. On Friday India reported a new daily record of 414,188 confirmed cases and 3,915 additional deaths. The official daily death count has stayed over 3,000 for the past 10 days.
That brings the total to more than 21.4 million COVID-19 infections and over 234,000 deaths. Experts say even those dramatic tolls are undercounts. (associated press)
Oregon church tied to outbreak
In early April, dozens of maskless churchgoers in northwest Oregon stood onstage singing and clapping inside a packed indoor venue for Easter Sunday service. The Peoples Church, which previously sued the state over coronavirus restrictions, hosted three similar indoor services that day, each lasting a little over an hour.
Days later, the state’s health authority began investigating a potential outbreak at the Salem church.
Now, the Oregon Health Authority says that at least 74 people associated with the church have tested positive for the coronavirus — one of the state’s largest workplace outbreaks.
In a statement, the church’s leaders attributed the outbreak to a recent rise in covid-19 cases in Marion County, Ore. ’'We are concerned about the covid-19 surge in Oregon,’' Executive Pastor Tom Murray said in an email to The Washington Post. ’'This statewide increase has impacted our entire region, including our church family.’'
Murray said the church, which has held in-person services throughout the pandemic, intends to continue with in-person services on Sunday. (Washington Post)
Britain easing ban on leisure travel
Britain will permit relatively open leisure travel to just 12 nations and territories including Portugal — but not the US — as it seeks to restart tourism while keeping control over the coronavirus pandemic.
A legal ban on international leisure trips will be eased from May 17, the Department for Transport confirmed on Friday. Return journeys from approved countries will require Covid-19 tests but no period of quarantine.
Also on the “green list” with Portugal and its island provinces of Madeira and the Azores are Israel, Iceland, the Faroes, Singapore, Brunei, New Zealand, and Australia, together with the British territories of Gibraltar and the Falklands. There’s no place for the European holiday hotspots of Spain, Greece, and France, and trans-Atlantic trips vital to some airlines remainon hold.
Virgin Atlantic Airways Ltd. called the development an important step but said the government had been “overly cautious” and that there’s no reason the US shouldn’t be immediately added to the green list. Its concern was echoed by EasyJet and the British Airline Pilots Association. (Bloomberg)