Health News Roundup: EU regulator backs bivalent COVID shots for primary vaccination; French drug agency says under investigation over thyroid drug and more
The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants. Pfizer partners with Clear Creek Bio to develop oral COVID-19 drug Pfizer Inc and Clear Creek Bio Inc on Tuesday announced a collaboration to identify a potential drug candidate and develop a new class of oral treatment against COVID-19, as Pfizer seeks to expand its anti-infective pipeline.
Following is a summary of current health news briefs.
EU regulator backs bivalent COVID shots for primary vaccination
The European Medicines Agency said on Tuesday its emergency task force has concluded that messenger RNA bivalent COVID-19 vaccines, targeting the original strain and the Omicron BA.4-5 subvariants, may be used in previously unvaccinated children and adults. The recommendation is based on data which shows that primary vaccination with the adapted bivalent vaccines should give rise to a broad immune response in people who have not yet been exposed to or vaccinated against COVID-19, the agency added.
French drug agency says under investigation over thyroid drug
France's ANSM national drug agency said it is under formal investigation on suspicion of issuing misleading information regarding German drugmaker Merck's thyroid drug Levothyrox, adding it contested the provisional charges. "The ANSM has never denied the difficulties encountered by some patients during the changeover to the new Levothyrox formula and works each and every day for the safety and health of patients," ANSM said in a statement late on Monday.
Minnesota nurses reach tentative deal with hospitals to avoid strike
The union representing thousands of Minnesota nurses said on Tuesday it had reached a tentative agreement with hospitals on a new contract that, if approved by members, would resolve a labor dispute without a threatened strike. Some 15,000 nurses in the Twin Cities and Duluth areas who staged a three-day walkout in September had vowed to strike at least through the end of the year if a deal was not reached over pay hikes and working conditions.
China medical expert says COVID has mutated, should be renamed - state media
China should change its official name for COVID-19 to reflect the virus' mutation, and patients with light symptoms should be allowed to quarantine at home, a leading authority on traditional Chinese medicine was quoted as saying on Wednesday. Gu Xiaohong told the state-run Beijing Daily newspaper that the coronavirus' Chinese name, which identifies it as a pneumonia-causing disease, should be changed to call it simply an infectious virus.
Chile investigates hepatitis A-tainted raspberries recalled in U.S.
Chile's government launched an investigation on Tuesday after raspberries from a Chilean company were recalled in the United States due to hepatitis A contamination. U.S. Food and Drug Administration (FDA) testing found the presence of hepatitis A in James Farm brand frozen raspberries from the South American country, a major exporter of raspberries, blueberries, grapes and cherries.
E-cigarette maker Juul reaches settlement with nearly 10,000 plaintiffs
E-cigarette maker Juul Labs on Tuesday said it has reached settlements with about 10,000 plaintiffs covering more than 5,000 cases in California. Juul did not disclose the settlement amount as part of the settlement and court process in the federal multidistrict litigation and related JUUL Labs Product Cases. The company has obtained equity investment to fund it, a spokesperson told Reuters in a statement.
U.S. FDA to review Emergent's OTC opioid overdose drug on priority
Contract drugmaker Emergent Biosolutions said on Tuesday its over-the-counter nasal spray as a treatment for a suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country.
Britain's health regulator backs COVID vaccine for infants from six months
Britain's health regulator on Tuesday authorized a COVID-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants.
Pfizer partners with Clear Creek Bio to develop oral COVID-19 drug
Pfizer Inc and Clear Creek Bio Inc on Tuesday announced a collaboration to identify a potential drug candidate and develop a new class of oral treatment against COVID-19, as Pfizer seeks to expand its anti-infective pipeline. Charlotte Allerton, Pfizer's chief scientific officer, said COVID-19 has "the potential to remain a global health concern for years to come".
GSK, Pfizer, Sanofi fend off thousands of U.S. lawsuits over alleged Zantac cancer link
Drugmakers GSK Plc, Pfizer Inc, Sanofi SA and Boehringer Ingelheim on Tuesday were spared thousands of U.S. lawsuits claiming that the heartburn drug Zantac caused cancer, as a judge found the claims were not backed by sound science. The ruling by U.S. District Judge Robin Rosenberg in West Palm Beach, Florida, knocks out about 50,000 claims in federal court, though it does not directly affect tens of thousands of similar cases pending in state courts around the country.
(With inputs from agencies.)