Vaccine makers file to obtain full FDA approval
Nations worldwide grapple with coronavirus hot spots
Pfizer and BioNTech have distributed more than 170 million doses of their coronavirus vaccine around the U.S. under an emergency authorization from the Food and Drug Administration. Now the companies have filed a request for full approval from the FDA for patients 16 and older.
The approval process is likely to take months. The designation would mark another important step for Pfizer and BioNTech, allowing them to directly market the drug and offer booster shots against coronavirus variants without first seeking new emergency authorization, Forbes magazine reported.
Full approval could also help raise confidence in the vaccine. The pace of vaccination has slowed in the United States in recent weeks, and a recent national survey indicated that most people in the country who planned to get the shots had already done so.
It could also make it easier for companies, government agencies and schools to require vaccinations. The Equal Employment Opportunity Commission has said employers could mandate vaccinations, and legal experts have generally agreed. Full approval could also prompt the U.S. military, which has had low uptake of covid-19 vaccines, to mandate shots for service members.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, chairman and chief executive officer of the American multinational Pfizer, said in a statement provided to The Washington Post. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
The FDA first granted an emergency authorization for the Pfizer-BioNTech vaccine Dec. 11, a designation later granted to vaccines from Moderna and Johnson & Johnson, as well.
The rule allows federal regulators to “authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency,” such as the pandemic, which has killed almost 581,000 people in the United States.
But that authorization lasts only as long as a public health emergency continues and limits the producers’ ability to market the drugs. On Friday, Pfizer submitted a host of new data — including six months’ worth of information on the vaccine’s safety and efficacy — in seeking full approval.
The request comes as public health experts expect the FDA to grant a new emergency authorization as soon as next week for 12- to 15-year-olds to receive the Pfizer-BioNTech shots. The companies have also said they plan to file for emergency authorization for 2- to 11-year-olds in September.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA [Biologics License Application] submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, co-founder and chief executive officer of the German company BioNTech, said in a statement.
Moderna plans to apply for full approval for its vaccine this month, it said Thursday.
Meanwhile, countries worldwide wrestling with new coronavirus surges are working to ensure that they aren’t hit by an India-style disaster. They face many of the same risks, including large populations that have shirked restrictions and fragile health systems that are straining.
In a province along the Nile in southern Egypt, hospitals have been flooded with patients, a hot spot in a third spike swelling across the country. Doctors in Sohag province warn that the health system there could collapse, even as the government rushes in new supplies.
“My estimate is that there is no family in Sohag that does not have a corona case,” said Dr. Mahmoud Fahmy Mansour, head of the province’s doctors union. “We lost five physicians in one week.”
He said a scenario like India was a possibility, but “God willing, it is a very far possibility.”
Long reluctant to impose new lockdowns, Egypt’s government announced its strictest restrictions in months Wednesday. It ordered cafes, restaurants, stores and malls to close at 9 p.m. and banned large gatherings for two weeks. It also closed beaches and parks for the Wednesday-Thursday Eid elFitr holiday at the end of the holy month of Ramadan.
Egypt is hardly alone. Worldwide, more cases have been reported in the past two weeks than in the entire first six months of the pandemic, said World Health Organization Director-General Tedros Adhanom Ghebreyesus.
India and Brazil accounted for a large part of that, “but there are many other countries all over the world that face a very fragile situation,” he said. “What is happening in India and Brazil could happen elsewhere unless we all take these public health precautions.”
India has been hit by a catastrophic surge after its prime minister boasted of vanquishing the pandemic and following multiple large crowding events. New cases and deaths skyrocketed nearly 30-fold during March and April. The health system has been overwhelmed, leaving patients desperate for oxygen and other supplies.
Wealthier nations, as they immunize more of their populations, are finding room to open up. But countries where vaccinations have been slow or minimal face grimmer prospects. They must grapple with whether to lock down to thwart new surges and risk damaging their economies — all with the possibility of an India-style tragedy looming.
In Turkey, new cases surged nearly six-fold from the beginning of March, reaching a peak of more than 60,000 a day. The government imposed a three-week national lockdown April 29 but exempted many sectors, allowing millions of people to keep going to work.
Numbers have fallen, but medical experts are calling for a 28-day full closure of all nonessential services. Only about 10 million of its more than 80 million people have been fully vaccinated.
In the crowded Palestinian enclave of the Gaza Strip, home to 2 million people, cases have risen swiftly. In March and April, infection rates surpassed 1,000 a day — the number Gaza previously recorded weekly. Daily deaths have doubled to a high of 20. The virus has killed more than 900 Gazans and sickened more than 102,000, more than half of them this year.
“Hospitals are struggling to cope,” the international aid group Doctors Without Borders warned this week.
The territory’s Hamas rulers closed mosques and restaurants, and imposed a nighttime curfew at the beginning of Ramadan to slow the outbreak, but it decided to lift those restrictions for the final 10 days of the holy month, alarming health officials.
In South Africa, with by far the largest number of covid-19 cases and deaths in Africa, officials warn of a new surge as the Southern Hemisphere’s winter approaches.
Pakistan is in the midst of a third wave, with single-day fatalities hitting their highest of the entire pandemic April 28, with 201 deaths.
Health officials added hundreds of hospital beds. Oxygen production had already been nearly doubled to 800 tons a day compared with last year. Still, at the surge’s peak in recent weeks, it was using 90% of that production.
New cases have eased slightly this week from a running average of about 6,000 a day.
“Thank God, we have so far managed to cope with this huge increase because of proactively building capacity of the entire system,” Planning and Development Minister Asad Umar said.
But he warned that the country of more than 200 million people could face an India-level disaster unless people adhere to precautions that have been widely ignored. The government has rejected calls for a lockdown but warns that could change.
“Be careful. For yourself, and your loved ones,” Umar said in a tweet.
CHINA VACCINE
The WHO gave emergency-use authorization Friday to a vaccine manufactured by China’s Sinopharm, potentially paving the way for millions of the doses to reach needy countries through a United Nations-backed program.
The decision by a WHO technical advisory group — a first for a Chinese vaccine — opens the possibility that Sinopharm’s offering could be included in the U.N.backed Covax program in coming weeks and distributed through UNICEF and the WHO’s Americas regional office.
Aside from efficacy numbers, the Chinese manufacturer has publicly released little data about its two vaccines — one developed by its Beijing Institute of Biological Products and the other by the Wuhan Institute of Biological Products.
The Beijing shot is the one the WHO advisory group gave emergency-use approval.
It will join the ones made by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca, and a version of the AstraZeneca vaccine made by the Serum Institute of India, in receiving authorization from the U.N. health agency.
The Chinese vaccine, which has already been exported in the millions of doses in some countries, could join the U.N.’s arsenal at a time when supplies of other vaccines have been lacking.
The addition “has the potential to rapidly accelerate covid-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr. Mariangela Simao, WHO assistant director general for access to health products.
Medical regulators in the European Union, Britain and the United States have not examined the Sinopharm vaccine, which relies on relatively old technology.
BOOST EXPORTS
Also Friday, the EU called on the U.S. to start boosting its vaccine exports to contain the global crisis and said Washington’s backing of patent waivers would provide only a long-term solution at best.
“We invite all those who engage in the debate of a waiver for (intellectual property) rights also to join us to commit to be willing to export a large share of what is being produced in that region,” said EU Commission President Ursula von der Leyen.
French President Emmanuel Macron summarized the view from Europe when he said at an EU summit in Porto, Portugal: “You can give the intellectual property to laboratories that do not know how to produce it; they won’t produce it tomorrow.”
Spanish Prime Minister Pedro Sanchez gave the idea endorsed by Biden this week a guarded welcome, but added, “We believe it is insufficient. It should be more ambitious.”
While the U.S. has kept a tight lid on exports of American-made vaccines so it can inoculate its own population first, the EU has become the world’s leading provider.
Von der Leyen said any patent waiver “will not bring a single dose of vaccine in the short- and medium-term.”
Macron said it was more important for Biden to work on exports. “The Anglo-Saxons block many of these ingredients” needed to make vaccines, the French leader said, referring to Washington and London. “Today, 100% of vaccines produced in the United States of America are for the American market.”
Von der Leyen said this week that the EU had distributed about 200 million doses within the bloc while about the same amount had been exported abroad.
“Around 50% of what is being produced in Europe is exported to almost 90 countries,” she said, calling on Biden and other vaccine-producing regions or nations to step up their efforts.
Information for this article was contributed by Tim Elfrink of The Washington Post; by Emily Anthes of The New York Times; and by Samy Magdy, Jamey Keaten, Suzan Fraser, Munir Ahmed, Sam Olukoya, Fares Akram, Andrew Meldrum, Cara Anna, Huizhong Wu, Lauran Neergaard, Maria Cheng, Raf Casert and Barry Hatton of The Associated Press.