Health Highlights, April 22, 2021
COVID-19 Vaccines Safe for Pregnant Women: Study
A new study adds to growing evidence that the Moderna and Pfizer COVID-19 vaccines are safe for pregnant women.
It included more than 35,000 pregnant women in the U.S. who received either of the vaccines, and found that their rates of miscarriage, premature birth and other complications were similar to those in pregnant women before the pandemic, the Associated Press reported.
The preliminary results from U.S. Centers for Disease Control and Prevention researchers were published Wednesday in the New England Journal of Medicine.
The researchers did not assess the one-shot Johnson & Johnson vaccine, which wasn't approved in the U.S. at the time of the study.
In related news, the American Society for Reproductive Medicine has endorsed COVID-19 vaccination in pregnancy, the AP reported.
''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.
Dr. Laura Riley, ob-gyn chair at New York's Weill Cornell Medicine, called the new results reassuring.
''It is great to have data to share with our patients who continue to weigh the risks and benefits of vaccination," she told the AP. "They know the potential complications of COVID infection in pregnancy and now there is some safety data in human pregnancies."
Fake Pfizer COVID-19 Vaccines Being Sold Online
Counterfeit versions of Pfizer's COVID-19 vaccines are being sold online, the company warns.
It said fake versions of the vaccines were found in Mexico and Poland, and that those in Mexico had fraudulent labeling, while those in Poland likely contained an anti-wrinkle treatment, CBS News reported.
Pfizer emphasized that no legitimate vaccine is sold online.
"We are cognizant that in this type of environment – fueled by the ease and convenience of e-commerce and anonymity afforded by the Internet – there will be an increase in the prevalence of fraud, counterfeit and other illicit activity as it relates to vaccines and treatments for COVID-19," a Pfizer spokesperson said, CBS News reported.
One COVID-19 Vaccine Dose Wasted for Every 850 Used: CDC Data
One dose of COVID-19 vaccine was thrown out for every 850 doses administered in the United States, according to Centers for Disease Control and Prevention data up to March 29.
By that date, 182,874 doses were reported as wastage by 35 states, 17 pharmacies and three other federal agencies, CNN reported.
The data also show that pharmacies accounted for three-quarters of the reported wastage, or about 137,000 doses.
The wasted doses represent less than 1% of the 155 million doses reported administered by March 29, and the CDC has noted that some wastage is expected with any vaccine, CNN reported.
COVID-19 vaccine wastage is likely higher than suggested by the data because 15 states didn't report any wastage through a CDC tracking system.
Multiple Violations at Baltimore Plant Making COVID-19 Vaccines: FDA
Improper disinfection and not following contamination prevention protocols are among the nine violations found by U.S. Food and Drug Administration inspectors at a Baltimore plant that had to discard up to 15 million doses of Johnson & Johnson's coronavirus vaccine and was ordered to temporarily halt all production.
The inspection at the Emergent BioSolutions plant -- a subcontractor of Johnson & Johnson -- was conducted after reports that workers had contaminated a batch of Johnson & Johnson vaccine doses with the harmless virus used to deliver AstraZeneca's vaccine, which is also made at the plant, according to The New York Times.
The violations included: not properly disinfecting the factory and its equipment; not following procedures meant to prevent contamination of doses and to ensure the strength and purity of the vaccines made at the plant; improperly trained employees; and problems with the design of the building, according to the inspection completed Tuesday.
The FDA said it has not authorized Emergent to distribute any Johnson & Johnson vaccine doses, and that no vaccine made at the plant has been released for use in the United States, the Times reported.
AstraZeneca's vaccine hasn't been approved for use in the United States and all the Johnson & Johnson doses used in the country so far were made in other countries.
"We will not allow the release of any product until we feel confident that it meets our expectations for quality," Dr. Janet Woodcock, the FDA's acting commissioner, and Dr. Peter Marks, the agency's top vaccine regulator, said in a statement.
The agency said it was working with Emergent to fix the problems. Earlier this month, the FDA said the AstraZeneca vaccine could no longer be made at the plant to reduce the risk of cross-contamination with the Johnson & Johnson vaccine, the Times reported.
In a statement, the Emergent said that "while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them."
Johnson & Johnson said in a statement that it's stepped up oversight of Emergent and that it would "ensure that all of FDA's observations are addressed promptly and comprehensively," the Times reported.