The Food and Drug Administration is expected to authorize new COVID-19 booster shots this week that target the latest versions of the omicron variant, but will do so without data from a study showing the shots were safe and worked in humans.
Authorizing doses, without data from human tests known as clinical trials, is similar to the approach the FDA takes with influenza vaccines, which are updated annually to track mutating influenza viruses, such as reported the Wall Street Journal.
“Real-world evidence from current COVID-19 mRNA vaccines, which have been given to millions of individuals, shows us that vaccines are safe,” FDA Commissioner Robert Califf said in a recent tweet. .
Perhaps the biggest challenge once the boosters become available will be their passage, given that Congress has not agreed to release the billions of dollars needed to pay for distribution and deployment to vaccination sites, as reported by the New York Times.
The federal government ran out of money this spring to reimburse injections given to uninsured people. At the same time, local health officials have reduced their outreach to unvaccinated people and most of the country behaves as if the pandemic is over. Local authorities are also distracted by the efforts needed to contain an outbreak of monkeypox and new cases of polio.
The overall COVID vaccination program has been more or less at a standstill for several months, with numbers provided by the Centers for Disease Control and Prevention barely budging from week to week.
Known cases of COVID in the United States continue to decline, although the true count is likely higher given the number of people testing at home, with data not being collected.
The daily average of new cases stood at 88,391 on Sunday, according to a New York Times tracker, down 14% from two weeks ago. Average daily hospitalizations fell 10% to 38,252, while average daily deaths fell 2% to 478.
While these numbers are well below the peaks seen in late 2021 and early 2022, it still means the country is incurring 9/11 level casualties roughly every six days.
Meanwhile, time is running out for Americans to get their batch of free COVID-19 tests from the government.
The program is set to be suspended on September 2 – which is this Friday – or even earlier, if supplies run out, according to a post on the COVID testing site.
Every US household is entitled to eight free rapid antigen tests per order, for a total of 16 free tests. The program began in January, offering four tests per household, then expanded into March and May.
Anyone who has not used their lot can still order them in the coming days by registering online at https://special.usps.com/testkits, or by calling 1-800-232-0233. Testing is free and there are no shipping costs.
Other COVID-19 news you should know:
Omicron-targeting bivalent COVID booster for use in adults 18 years of age and older. Swissmedic made its decision based on data from a phase 2/3 trial showing the booster increased neutralizing antibodies against omicron about eight times above baseline levels, it added. It also produced higher neutralizing antibody titers against BA.4 and BA.5, the latter of which has become the dominant subvariant worldwide, according to the World Health Organization. Moderna is working to get the product to Switzerland by early September.
• The US Secret Service has recovered $286 million in fraudulently obtained pandemic loans and is handing over the money to the Small Business Administration, the Associated Press reported. The Secret Service said an investigation by its Orlando office revealed suspected conspirators submitted economic disaster loan applications using fake or stolen jobs and personal information and used a bank in line, Green Dot.
to conceal and move their criminal proceeds.
• Authorities in the city of Shenzhen in southern China closed the world’s largest electronics market, Huaqiangbei, on Monday and suspended service at 24 subway stations in a bid to curb a COVID outbreak , Reuters reported. Three key buildings in the sprawling area, featuring thousands of stalls selling microchips, phone parts and other components to manufacturers, will remain closed until September 2.
• Japan is considering allowing asymptomatic COVID patients to leave their homes to buy basic necessities as long as they wear a mask and take other measures against the spread of the virus, the Japan Times reported, citing government sources. The proposal comes as cases are at record highs in many regions in a seventh wave of the pandemic that shows no signs of abating.
Here’s what the numbers say
The global tally of confirmed COVID-19 cases topped 601 million on Monday, while the death toll topped 6.48 million, according to data aggregated by Johns Hopkins University.
The United States leads the world with 94.2 million cases and 1,043,858 deaths.
The Centers for Disease Control and Prevention Tracker shows that 223.9 million people living in the United States are fully immunized, or 67.4% of the total population. But only 108.5 million had a first booster, or 48.5% of the vaccinated population.
Only 21.8 million people aged 50 and over eligible for a second booster had one, or 33.7% of those who had a first booster.