EU to Decide on Third COVID-19 Shot in Early October

2021-09-23

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The European Union's drug watchdog said Thursday that it planned to decide in early October whether to approve a third dose of the Pfizer-BioNTech COVID-19 vaccine for those over age 16.

The European Medicines Agency (EMA) said breakthrough infections in those already vaccinated had added urgency to its review of a third dose for people 16 and older, six months after being fully vaccinated.

"The outcome of this evaluation is expected in early October, unless supplementary information is needed," EMA official Marco Cavaleri said at a news briefing.

In the United States on Wednesday, the U.S. Food and Drug Administration approved a third dose of the Pfizer vaccine for people 65 and older, those at high risk of severe disease and people who are routinely exposed to the coronavirus.

Meanwhile, pregnant women who are vaccinated against COVID-19 also pass on the coronavirus antibodies to their unborn children, according to a study published this week in the American Journal of Obstetrics and Gynecology: Maternal-Fetal Medicine.

Researchers at New York University's Grossman School of Medicine examined 36 newborns whose mothers received either the Pfizer or Moderna two-dose vaccine before giving birth, and found that all the babies had antibodies when they were delivered.

The study did not determine how well the babies were protected from COVID-19, which is the illness caused by the virus, or how long the protection might last.

Scientists have discovered that pregnant women develop antibodies in response to a vaccine or an infection, then pass them on to their babies either through the umbilical cord or breast milk.

"Studies continue to reinforce the importance of vaccines during pregnancy and their power to protect two lives at once by preventing severe illness in both mothers and babies," said Dr. Ashley Roman, one of the study's principal investigators.

The U.S. Centers for Disease Control and Prevention last month urged pregnant women and women who were recently pregnant to get vaccinated for COVID-19, saying there is mounting evidence that the benefits of the shot far outweigh any known or potential risks.

In related news:

- Portugal will lift most remaining COVID-19 restrictions on October 1, Prime Minister Antonio Costa said Thursday.

- A study published in the medical journal Nature Communications found that some COVID-19 patients develop so-called "autoantibodies," or self-destructive antibodies, that could trick the immune system into attacking otherwise healthy tissue and cause inflammatory diseases. Scientists at Stanford University found autoantibodies in blood samples of at least 50% of nearly 150 patients admitted for treatment of COVID-19, compared with 15% of 41 healthy volunteers.

The researchers found the antibodies have the potential to aggravate the symptoms of COVID-19.

- The U.S. Olympic and Paralympic Committee has issued a mandatory vaccination rule for all athletes aiming to compete in next year's Winter Games in Beijing.

A letter issued Wednesday by Sarah Hirshland, the chief executive of USOPC, sets a November 1 deadline for all athletes and team staff members to be fully inoculated against COVID-19, with a deadline of December 1 for any athlete who is selected to join the Team USA delegation to show proof of vaccination.

"The stark reality is that this pandemic is far from over," Hirshland wrote. "This step will increase our ability to create a safe and productive environment for Team USA athletes and staff, and allow us to restore consistency in planning, preparation and service to athletes."

The Beijing Winter Games are scheduled to begin on February 4, 2022, with the Paralympic Games to follow one month later. The International Olympic Committee did not mandate vaccinations for athletes who competed in this year's Tokyo Games.

- The foundation that awards the Nobel Prizes announced Thursday that its annual banquet for the laureates in Stockholm, Sweden, has been canceled for the second consecutive year because of the pandemic. The Nobel Foundation said the winners for medicine, physics, chemistry, literature, peace and economics would receive their medals and diplomas in their home countries.

In a statement announcing the decision, the foundation said, "Everybody would like the COVID-19 pandemic to be over, but we are not there yet."

Some information for this report came from The Associated Press and Reuters.