New data reassuring for COVID-19 vaccination in pregnancy
One of the largest reports on COVID-19 vaccination in pregnancy bolsters evidence that it is safe, although the authors say more comprehensive research is needed.
The preliminary results are based on reports from more than 35,000 U.S. women who received either the Moderna or Pfizer shots while pregnant. Their rates of miscarriage, premature births and other complications were comparable to those observed in published reports on pregnant women before the pandemic.
The new evidence from researchers at the Centers for Disease Control and Prevention was published Wednesday in the New England Journal of Medicine.
Separately, the American Society for Reproductive Medicine on Tuesday endorsed vaccination in pregnancy, based on evidence it has been evaluating for more than a year.
‘’Everyone, including pregnant women and those seeking to become pregnant, should get a COVID-19 vaccine. The vaccines are safe and effective,’’ the society said in a statement.
FDA inspection found problems at factory making J&J vaccine
The Baltimore factory hired to help make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material going into a batch of shots, U.S. regulators said Wednesday.
The Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled Emergent BioSciences factory.
Agency inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.
Other problems cited in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredients.
Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.
Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.
Israel says it strikes targets in Syria after missile attack
JERUSALEM — A missile launched from Syria struck southern Israel early Thursday, setting off air raid sirens near the country’s top-secret nuclear reactor, the Israeli military said. In response, it said it attacked the missile launcher and air-defense systems in neighboring Syria.
The incident, marking the most serious violence between Israel and Syria in years, pointed to likely Iranian involvement. Iran, which maintains troops and proxies in Syria, has accused Israel of a series of attacks on its nuclear facilities, including sabatoge at its Natanz nuclear facility on April 11, and vowed revenge. It also threatened to complicate U.S.-led attempts to revive the international nuclear deal with Iran.
The Israeli army said the missile landed in the Negev region and the air raid sirens were sounded in a village near Dimona, where Israel’s nuclear reactor is located. The army later said the incoming missile caused no damage.
Syria’s state-controlled SANA news agency said four soldiers were wounded in an Israeli strike near Damascus, which also caused some damage.