Pfizer Inc. and BioNTech SE have asked the U.S. Food and Drug Administration to authorize their three-dose vaccine for children aged six months to five years, in a move that could add roughly 19 million young children to the program.
The companies PFE, -2.35% BNTX, -2.12% said last month that three doses of their shot were 80% effective at preventing symptomatic COVID-19 and generated a robust immune response in children in that cohort, while also appearing safe and well-tolerated, as the Wall Street Journal reported.
FDA authorization could come before the end of June, at which point the Centers for Disease Control and Prevention will be the agency to sign off on the last remaining group to be added to the nation’s vaccine push. Shots would be available at doctors’ offices, pharmacies and other locations.
The FDA is already reviewing a request from Moderna MRNA, -6.80% to authorize two shots of its vaccine, also an mRNA one, to children below the age of six.
Moderna said Thursday it has revised an agreement with the European Commission on the delivery schedule for its vaccine booster or updated booster vaccine candidate.
The revision will allow member states to have Moderna vaccine booster doses scheduled for delivery in the second quarter to be delivered later in the calendar year 2022 or in early 2023. It will also alow member states to have the possibility to receive the expected updated bivalent booster candidate should it be approved by the European Medicines Agency.
The bivalent prototype and booster vaccine candidate directed at the omicron variant is being evaluated in a Phase 2/3 study with initial data expected in June. That data is expected to inform selection of its candidate for the Northern Hemisphere fall 2022 booster, said Moderna.
The company is still expecting its advanced purchase agreements to total about $21 billion in 2022 and expects sales to be slightly higher in the second half than the first.
The news comes as U.S. COVID cases seem to be stabilizing again after a steady climb caused by omicron and its subvariants. The U.S. is averaging 109,551 cases a day, down 1% from two weeks ago, according to a New York Times tracker.
The country is averaging 27,226 hospitalizations a day, up 16% from two weeks ago. The daily death toll has fallen to 279 on average, down 8% from two weeks ago. Cases are stabilizing in states in the Northeast that were recent hot spots.
But the World Health Organization cautioned on Wednesday that case numbers globally are being distorted by changes in how they are conducted, resulting in lower overall numbers of tests performed and consequently lower numbers of cases being detected.
Many Americans are now testing at home and the data are not being collected.
Meanwhile, the White House is warning that the U.S. is headed for “a lot of unnecessary loss of life,” if Congress fails to provide billions more dollars to brace for the pandemic’s next wave, as the Associated Press reported.
The quest for that money is in limbo, the latest victim of election-year gridlock that’s stalled or killed a host of Democratic priorities.
President Joe Biden’s appeal for funds for vaccines, testing and treatments has hit opposition from Republicans, who’ve fused the fight with the precarious politics of immigration. Congress is in recess, and the next steps are uncertain, despite admonitions from White House COVID-19 coordinator Dr. Ashish Jha of damaging consequences from “every day we wait.”
Jha will join White House press secretary Karine Jean-Pierre at a briefing later Thursday at 3 p.m. ET.
Administration officials say they are running low on money to stock up on, or even begin to order, the latest vaccines, tests and treatments. Also lacking are funds to reimburse doctors treating uninsured patients and to help poor countries control the pandemic.
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Other COVID-19 news you should know about:
• A landmark park in Shanghai has reopened after the easing of COVID restrictions that confined most of the city’s residents to their homes for two months, the AP reported. Yuyuan Garden in the center of Shanghai’s historic old town was busy Thursday as visitors flocked to one of their favorite haunts. In-restaurant dining is still forbidden in Shanghai, Beijing and other Chinese cities and many communities remain under various levels of lockdown.
• Two more U.S. cabinet secretaries have tested positive for COVID, the New York Times reported. Officials said the two, Labor Secretary Martin J. Walsh and Interior Secretary Deb Haaland, have not been in close contact with President Joe Biden. The pair confirmed the news in tweets.
• Iran’s health minister said Thursday the country has marked its first day after more than two years without a single COVID-19 death, welcoming the news as a significant milestone for a nation that long had the highest number of coronavirus cases in the Middle East, the AP reported. The ministry reported 175 new cases over the past day, bringing Iran’s number of confirmed cases during the pandemic to more than 7,230,000. Iran’s officially registered death toll stands at 141,318.
• As many as two million people living in the U.K. are suffering from long COVID, according to data from the Office of National Statistics. The most common symptom reported is fatigue, with 55% of those self-reporting naming it as one way that day-to-day activities have been limited. That was followed by shortness of breath at 32%, a cough, named by 23%, and muscle ache, named by 23%. “As a proportion of the U.K. population, the prevalence of self-reported long COVID was greatest in people aged 35 to 69 years, females, people living in more deprived areas, those working in social care, teaching and education or health care, and those with another activity-limiting health condition or disability,” the ONS said in a statement.
Here’s what the numbers say
The global tally of confirmed cases of COVID-19 topped 530.8 million on Tuesday, while the death toll rose above 6.29 million, according to data aggregated by Johns Hopkins University.
The U.S. leads the world with 84.4 million cases and 1,007,719 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 221.3 million people living in the U.S. are fully vaccinated, equal to 66.7% of the total population. But just 103.5 million have had a first booster, equal to 46.8% of the vaccinated population.
Just 14 million of the people aged 50 and over who are eligible for a second booster have had one, equal to 22.4% of those who had a first booster.