Vaccine for kids under 5 could be available in late February; senators urge DOJ to deter sale of fake masks: Latest updates
Pfizer and its partner BioNTech on Tuesday requested FDA clearance for their low-dose COVID-19 vaccine for children 6 months to just under 5 years old, a major step that could make the shots available by the end of February.
Food and Drug Administration officials had urged the companies to pursue emergency authorization for a two-dose regimen of the vaccine while awaiting data on a three-dose course, the Associated Press reported.
Tuesday's filing could accelerate the availability of vaccines for kids of pre-school age by more than a month.
COVID-19 infections among children have spiked in 2022 with the emergence of the omicron variant, surpassing 3.5 million cases in January – triple the peak level of the delta wave in 2021, according to the American Academy of Pediatrics.
The lower dose given to 2- to 4-year-olds was deemed safe but didn't produce as much immune protection as shots given to other age groups in early tests, Dr. Alejandra Gurtman, vice president of vaccine clinical research and development for Pfizer, said at a meeting of the Advisory Committee on Immunization Practices last month.
Kids ages 6 months to 2 years, however, did experience an adequate immune response at that 3-microgram dose, Gurtman said.
The company hopes a third dose of the vaccine eight weeks after the first two shots will provide the desired effectiveness, but those results won't be available until late March or early April. Applying for an EUA now would allow young children to get started on the vaccination regimen sooner while the merits of a third shot are studied.
Also in the news:
►U.S. Rep. Steny Hoyer of Maryland, the second-ranking Democrat in the House, said he has a breakthrough case of COVID-19.
►The previously coronavirus-free island nation of Tonga, trying to recover from a devastating volcanic eruption and tsunami last month, will go into lockdown Wednesday after two port workers who had been helping distribute international aid got infected.
►The Maryland biotechnology company Novavax said Monday it has submitted a request to the Food and Drug Administration for emergency use authorization of its protein-based COVID-19 vaccine.
►Washington state filed a lawsuit Monday against the Center for COVID Control, a nationwide coronavirus testing chain that operated more than 300 locations across the U.S., claiming it provided "invalid, false and delayed" COVID-19 test results to Washingtonians.
►COVID-19 hospitalizations continued to plummet in New Jersey over the weekend and are now less than half of what they were at their peak on Jan 11.
📈Today's numbers: The U.S. has recorded more than 75 million confirmed COVID-19 cases and 890,000 deaths, according to Johns Hopkins University data. Global totals: More than 381 million cases and over 5.6 million deaths. More than 211 million Americans – 63.8% – are fully vaccinated, according to the Centers for Disease Control and Prevention.
📘What we're reading: While travel is possible to most countries, vacationers can still expect to find COVID-related mandates in many beach towns. USA TODAY's Bailey Schulz reviews some of the most popular beach destinations' entry requirements and COVID-19 restrictions ahead of spring break 2022.
Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY's free Coronavirus Watch newsletter to receive updates directly to your inbox and join our Facebook group.
Senators press DOJ to root out fake N95 and KN95 masks
Three Democratic senators are urging the Justice Department to address the proliferation of fake N95 and KN95 masks on the market, a growing problem as Americans seek improved protection from the highly infectious omicron variant.
In a letter to Attorney General Merrick Garland, Senators Edward Markey and Elizabeth Warren of Massachusetts and Richard Blumenthal of Connecticut point out consumers are increasingly finding fraudulent masks for sale, and it can be difficult to tell if they're legitimate, especially when purchasing online.
The CDC says about 60% of the KN95 masks evaluated by the National Institute for Occupational Safety and Health in 2020 and 2021 were not up to requirements.
"We urge the DOJ to redouble its efforts to ensure that consumers are not vulnerable to fraudulent masks sold through brick-and-mortar and online retail settings,'' the letter says. "Americans trying to protect themselves, their families, and their communities should not face potentially life-threatening exploitation by unscrupulous actors.''
US had nearly as many cases in January as in all of 2020
There were almost exactly as many cases of COVID-19 reported in the U.S. in January as in all of 2020.
The country's 20,148,614 infections in January are just below 2020's complete tally of 20,193,451, a USA TODAY analysis of Johns Hopkins University data shows. The January case count was more than three times higher than the previous record for any month. Limited access to testing, home testing kits and undiagnosed asymptomatic infections mean the real number of people who contracted the coronavirus was higher.
The wildly contagious omicron variant also put record numbers of people into hospitals in January, even though on a per-case basis infections are milder.
A record 798,190 patients were hospitalized in January with confirmed or suspected COVID-19, according to USA TODAY analysis of a database of the U.S. Department of Health and Human Services. The 161,785 hospitalizations on Jan. 19 were the biggest number for any day on record.
But the thunderous omicron wave is receding. The pace of new cases has fallen some 44% since mid-January's peak, bringing them to an average of about 450,000 every day. Only four states – Maine, Minnesota, Montana and Tennessee – were still seeing rising case counts in the week ending Jan. 31.
Globally, the 90 million infections recorded since omicron was first identified 10 weeks ago add up to more than in all of 2020, the WHO said.
– Mike Stucka
Medical facilities struggle to manage extra health care waste, WHO says
Tens of thousands of tons of medical waste from the COVID-19 pandemic are straining waste management systems worldwide and threatening human and environmental health, according to a new World Health Organization report released Tuesday.
The findings are based on estimates on the approximately 87,000 tons of PPE requested from March 2020 to November 2021 to support countries' COVID-19 response and delivered through the United Nations. Materials from test kits and syringes, needles and boxes from the vaccine rollout have also created a tremendous amount of waste – far more than hospitals regularly handled before the pandemic.
"Today, 30% of health care facilities (60% in the least developed countries) are not equipped to handle existing waste loads, let alone the additional COVID-19 load," the WHO said.
Workers at facilities unable to manage the extra waste are more susceptible to "needle stick injuries, burns and pathogenic microorganisms," according to the report, and surrounding communities are more likely to suffer from "contaminated air from burning waste, poor water quality or disease carrying pests."
Fourth shot may help immunocompromised but not everyone
Evidence supports giving a fourth dose of COVID-19 vaccine to people with weakened immune systems, but it’s not clear whether fourth shots make sense for healthy Americans.
A third dose of the Pfizer-BioNTech vaccine or the Moderna vaccine has been extremely effective at preventing severe disease from the omicron variant, which accounts for virtually all the COVID-19 infections in the U.S.
The CDC authorized a fourth dose at least five months after a third for immunocompromised people – such as transplant recipients, cancer patients receiving certain treatments and people on certain medications. The CDC has not said whether it would consider allowing healthy people to get a fourth shot, nor has the FDA considered authorizing one.
Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, said to limit severe disease, the best approach would be to get more people vaccinated, not worry about giving four or more doses to people who are largely protected.
"We're focusing on the wrong group," Offit said. "If you really want to have an impact on this pandemic, vaccinate the unvaccinated."
– Karen Weintraub, USA TODAY
San Francisco allows second COVID-19 booster for all J&J takers
In mid-January, the San Francisco Department of Public Health became the first known official body in the country to sanction anyone with normal immune protection to get a second booster dose if they received the Johnson & Johnson vaccine as their first shot.
The department described the third dose as “an accommodation” based on recent studies that found a third dose of an mRNA COVID-19 vaccine, such as from Pfizer and Moderna, is needed to induce adequate protection as immunity wanes. The third dose reduces symptomatic infection, hospitalization and severe outcomes from the omicron variant. The second booster is only available to residents of San Francisco or people who got their initial J&J vaccination there.
In a release, the department said while the research so far has focused on people whose vaccines were either from Pfizer or Moderna, “We believe that similar studies in persons whose primary series was a single J&J vaccine dose would yield similar results showing that three doses are needed for optimal protection.”
– Elizabeth Weise, USA TODAY
This article originally appeared on USA TODAY: Pfizer seeks OK of kids vaccine; senators try to root out fake masks