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U.S. Orders 3.2 Million Doses of Novavax COVID Vaccine
The U.S. government will get 3.2 million doses of the COVID-19 vaccine developed by Novavax Inc. (NVAX.O) once the shot has been authorized by the regulators, the Department of Health and Human Services (HHS) and the company said on Monday.
The shot will be made available for free in the country after it gets authorization by the U.S. Food and Drug Administration (FDA) for emergency use and the Centers for Disease Control and Prevention’s (CDC) recommendation.
Advisers to the FDA last month voted to recommend that the agency authorize the shot for use in adults.
Novavax is expected to complete all necessary quality testing in the next few weeks, which would support the final release of the shots, HHS said in a statement on Monday.
U.S. FDA Grants Full Approval to Pfizer COVID Vaccine for Ages 12-15
The U.S. Food and Drug Administration said on Friday it has granted full approval to Pfizer (PFE.N) and BioNTech’s COVID-19 vaccine for adolescents aged between 12 and 15 years.
The vaccine, sold under the brand name Comirnaty for adults, has been available under an emergency use authorization since May 2021 for the 12-15 age group. It will now be sold under the same brand name for adolescents as well.
The FDA said on Friday the full approval follows a rigorous analysis and evaluation of the safety and effectiveness data. The vaccine was approved for use in those aged 16 and older in August last year.
U.S. Has 17M Monkeypox Vaccine Doses Stuck in Denmark as NYC Scrambles to Get Shots Into Arms: ‘Make the Vaccine Available to Everyone’
Nearly 17 million doses of monkeypox vaccine are collecting dust at a manufacturing plant in Denmark instead of being shipped to the U.S. due to a bureaucratic delay, White House officials confirmed Friday, as New Yorkers lined up in droves to get ahold of a shot from the city’s short supply.
The viral disease, which is spreading across the world, primarily among men who have sex with men, causes blister-like rashes, fever and other symptoms.
There are no known U.S. monkeypox deaths, and public health experts have stressed that the virus is less transmissible than COVID-19 — but that hasn’t quelled anxiety in New York City, which has emerged as an early epicenter, with 160 of the country’s roughly 700 cases reported here as of Friday.
About 6,000 monkeypox doses arrived in the city earlier this week, but the local Health Department and a third-party vendor, MedRite, bungled administering the shots, with reports of New Yorkers having their appointments canceled at the last minute due to flagging supply.
Over 10% of COVID Hospitalizations Involve Immunocompromised People — Once Hospitalized, No Mortality Difference Between Vaxxed and Unvaxxed Immunocompromised Patients
Immunocompromised individuals made up 12.2% of all COVID-related hospitalizations, despite accounting for only about 3% of the U.S. population, a CDC report showed.
And once hospitalized, there was no difference in the risk for death between vaccinated and unvaccinated immunocompromised patients, reported Jason Robert Singson, MPH, of the California Emerging Infections Program in Oakland, and colleagues in the Morbidity and Mortality Weekly Report.
Few Young Children Are Getting COVID Vaccines: Data
Uptake of COVID-19 vaccines has been low so far in young children, with a small fraction of those newly eligible for a vaccine receiving one, according to new data.
In a pair of moves in June, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) made the Moderna and Pfizer vaccines available to children from 6 months to 5 years of age and recommended virtually every child in the age group get vaccinated.
But parents have been hesitant to get their child a vaccine, according to the newly released data. Just 1.3% of eligible children under 5 have received one or two doses of a vaccine, data from the CDC show. In many states, meanwhile, the percentage of young children getting a shot is under 1%, according to an Epoch Times analysis.
Taken together, the statistics underline the difficulty health authorities will have in getting babies and toddlers vaccinated with shots that have proven much worse than originally promoted.
Judge Throws out Missouri AG’s COVID Suit Against China
A federal judge on Friday threw out a lawsuit by Missouri Republican Attorney General Eric Schmitt that blamed China for the coronavirus pandemic.
U.S. District Judge Stephen Limbaugh said in his 38-page ruling that in this case, federal rules prohibit a sovereign foreign entity from being sued in American courts. The judge noted earlier in the opinion that the civil suit against China is one of many filed “amidst the wreckage of the COVID-19 pandemic.”
Schmitt’s office said it would appeal the ruling.
The complaint filed in April 2020 alleges that Chinese officials are “responsible for the enormous death, suffering and economic losses they inflicted on the world, including Missourians.” Schmitt said the Chinese government lied about the dangers of the virus and didn’t do enough to slow its spread.
New Coronavirus Mutant Raises Concerns in India and Beyond
The quickly changing coronavirus has spawned yet another super contagious Omicron mutant that’s worrying scientists as it gains ground in India and pops up in numerous other countries, including the United States.
Scientists say the variant — called BA.2.75 — may be able to spread rapidly and get around immunity from vaccines and previous infection. It’s unclear whether it could cause more serious disease than other Omicron variants, including the globally prominent BA.5.
The latest mutant has been spotted in several distant states in India, and appears to be spreading faster than other variants there, said Lipi Thukral, a scientist at the Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology in New Delhi.
It’s also been detected in about 10 other countries, including Australia, Germany, the United Kingdom and Canada. Two cases were recently identified on the West Coast of the U.S., and Helix identified a third U.S. case last week.
EU Backs Second COVID Booster for Over-60s, Before Variant-Adapted Vaccines Are Ready
European Union health agencies on Monday recommended a second COVID-19 booster for everyone over 60, as well as medically vulnerable people, amid a new rise in infections and hospitalizations across Europe.
EU health agencies have since April recommended a second booster only for those older than 80 and the most vulnerable.
The new recommendation is expected to facilitate national decisions to speed up vaccination campaigns, which have been slowing to nearly a halt in recent months.
Shanghai Identifies New COVID Omicron Subvariant
The city of Shanghai has discovered a COVID-19 case involving a new subvariant Omicron BA.5.2.1, an official told a briefing on Sunday, signaling the complications China faces to keep up with new mutations as it pursues its “zero-COVID” policy.
The case, found in the financial district of Pudong on July 8, was linked with a case from overseas, said Zhao Dandan, vice-director of the city’s health commission.
Shanghai, in eastern China, emerged from a lockdown lasting around two months at the start of June, but it has continued to impose tough restrictions, locking down buildings and compounds as soon as new potential transmission chains emerge.
Zhao said residents in several major Shanghai districts would undergo two rounds of COVID tests, from July 12-14, in a bid to bring potential new outbreaks under control.
