The U.S. drug regulator on Friday added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use.
For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.
As of June 11, more than 1,200 cases of myocarditis or pericarditis have been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), out of about 300 million mRNA vaccine doses administered.
The cases appear to be notably higher in males and in the week after the second vaccine dose. The CDC identified 309 hospitalizations from heart inflammation in persons under the age of 30, of which 295 have been discharged.
Health regulators in several countries have been investigating cases of myocarditis and pericarditis, more frequently found in young men, after a shot of Pfizer or Moderna, vaccines that are based on the mRNA technology.
The latest update from FDA follows an extensive review of information and the discussion by CDC's Advisory Committee on Immunization Practices meeting on Wednesday.
Former Japanese Prime Minister Taro Aso, a senior figure in the country's ruling party, met with Donald Trump on Tuesday, becoming the latest US ally seeking to establish ties with the Republican presidential candidate.
Russian missiles damaged residential buildings and injured six people in Ukraine's second-largest city, Kharkiv, early on Wednesday, Governor Oleh Synehubov said on Telegram.
Five migrants died in an attempt to cross the English Channel from France to Britain in an overcrowded small boat on Tuesday, hours after Britain passed a bill to deport asylum seekers to Rwanda in a move to deter the dangerous journeys.
Israel bombarded northern Gaza overnight in some of the heaviest shelling in weeks, causing panic amongst residents and flattening neighbourhoods in an area from which the Israeli army had previously down its troops, residents said on Tuesday.
Russia launched a drone attack on Ukraine that injured seven people in the Black Sea port of Odesa, two of them children, and also targeted Kyiv, the capital, Ukraine's military officials said early on Tuesday.