Health News Roundup: U.S. FDA advisers to review Merck's oral COVID-19 drug next month; EU starts real-time review of AstraZeneca COVID-19 antibody cocktail and more
Multiple media reports have said Biden is focusing on former FDA commissioner Robert Califf, but Psaki said "not yet" when asked if the president has made a final decision. U.S. FDA advisers to review Merck's oral COVID-19 drug next month A panel of outside advisers to the U.S. health regulator will meet late next month to discuss whether to authorize Merck & Co's experimental COVID-19 antiviral drug, the agency said on Thursday.
Following is a summary of current health news briefs.
White House says Biden has yet to make a decision about new FDA commissioner
White House press secretary Jen Psaki said on Thursday that U.S. President Joe Biden has yet to make a final decision on who to nominate to lead the Food and Drug administration. Multiple media reports have said Biden is focusing on former FDA commissioner Robert Califf, but Psaki said "not yet" when asked if the president has made a final decision.
U.S. FDA advisers to review Merck's oral COVID-19 drug next month
A panel of outside advisers to the U.S. health regulator will meet late next month to discuss whether to authorize Merck & Co's experimental COVID-19 antiviral drug, the agency said on Thursday. The U.S. Food and Drug Administration's (FDA) panel will meet on Nov. 30 to discuss safety and effectiveness of the drug, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults who have tested positive and are at high risk for progression to severe illness. (https://refini.tv/3p1PETq)
Abbott Labs unit recalling two COVID-19 test kits - FDA
A unit of Abbott Laboratories is recalling two COVID-19 test kits as they can potentially issue false positive results, the U.S. Food and Drug Administration (FDA) said on Thursday. The regulator has identified the recall of the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP laboratory test kits by unit Abbott Molecular Inc as a Class 1 recall, the most serious type.
U.S. FDA advisers back Moderna COVID-19 booster shots for older and high-risk people
A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna Inc's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus. If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
EU starts real-time review of AstraZeneca COVID-19 antibody cocktail
Europe's drug regulator said on Thursday it had started a real-time review of AstraZeneca's antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus. The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review was based on early results from clinical studies, the regulator said https://www.ema.europa.eu/en/news/ema-starts-rolling-review-evusheld-tixagevimab-cilgavimab. It did not say when a conclusion was expected.
Russia asks pension-age doctors to return as COVID-19 cases soar
Russia called on pension-age doctors who quit during the pandemic for safety reasons to return to their jobs on Thursday as the authorities reported a record one-day tally of COVID-19 cases as well as a record number of deaths. The Kremlin has blamed the rising toll on Russia's slow vaccination campaign and has appealed to people to get the shot. Take-up has been slow, with many Russians citing distrust of the authorities and fear of new medical products.
France donates COVID-19 vaccine to Nigeria under COVAX scheme
Nigeria has received 501,600 doses of AstraZeneca's COVID-19 vaccine from the French government through the COVAX vaccine-sharing facility, a senior health official said on Thursday. Faisal Shuaib, head of the National Primary Health Care Development Agency, said the country also received 434,400 doses of Johnson and Johnson vaccine from the African Union.
U.S. donates 17 million J&J doses to African Union
President Joe Biden told visiting Kenyan President Uhuru Kenyatta on Thursday that the United States will make a one-time donation of more than 17 million doses of the Johnson & Johnson vaccine to the African Union, the White House said. The meeting with Kenyatta at the White House marked Biden's first as president with an African leader. Kenya holds the rotating presidency of the U.N. Security Council this month. The United States and Kenya have long cooperated on economic and security initiatives including counterterrorism.
U.S. vaccine mandates are working, Biden says, but 66 million still don't have shot
President Joe Biden touted the success of mandates in spurring vaccination against COVID-19 in the United States on Thursday but said more needed to be done to get the 66 million people who are eligible but still unvaccinated to get the shot. Vaccination rates against COVID-19 in the United States have risen https://www.reuters.com/world/us/vaccine-requirements-raised-covid-19-vaccination-rates-by-20-percentage-points-2021-10-13 by more than 20 percentage points after multiple institutions adopted vaccine requirements in recent months, while case numbers and deaths from the virus are down, Biden administration officials said on Wednesday.
US State Department defends handling of 'Havana Syndrome'
The State Department on Thursday defended its handling of so-called Havana Syndrome health complaints, after a bipartisan group of U.S. senators said they were concerned the unexplained ailments were not being taken seriously enough. Around 200 U.S. diplomats, officials and family members overseas are believed to have been struck by the mysterious ailment - with symptoms including migraines, nausea, memory lapses and dizziness.
(With inputs from agencies.)