CDC panel endorses Pfizer vaccine for ages 16 and up

Committee to issue further guidelines for young people, pregnant women and those with allergies

An independent committee of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted to recommend the Pfizer coronavirus vaccine for people 16 and older. That endorsement, which now awaits only final approval by Dr. Robert Redfield, the director of the CDC, is a key signal to hospitals and doctors that they should proceed to inoculate patients.

The endorsement follows Friday night’s emergency use authorization of the vaccine by the Food and Drug Administration, which oversees licensing of medical products.

The advisory committee, which typically meets three times a year to review amendments to routine schedules for child, adolescent and adult vaccines, has been engaged in numerous sessions this fall to discuss a plethora of issues surrounding the introduction of the vaccine, which is in limited supply, during a pandemic.

In meetings Friday and Saturday, the panel’s heated discussions centered mainly on three areas: whether to recommend the vaccine for patients 16 and 17 years old, for pregnant and lactating women and for patients who have had an anaphylactic reaction to other vaccines.

CDC officials and scientists will review the debate and post more precise guidance about those specific groups and others

Sunday and in the coming weeks, as more information about the vaccine becomes known.

Pregnant women were not included in clinical trials of the vaccine. The expert panel’s discussion about pregnancy centered on the fact that at least 330,000 health care workers in the first cohort of vaccine recipients are expected to be pregnant or lactating women. While the committee urged that the decision on whether to get the shot be left to pregnant women in consultation with their doctors, it also suggested they weigh their personal risk of being exposed to the virus against the efficacy of the vaccine and the paucity of data about it with respect to pregnancy.

The committee noted that because it is not a live-virus vaccine, it is not considered a risk to a breastfeeding infant.

Pfizer representatives said Friday that they had seen no evidence that the vaccine affects gestation or fertility. About two dozen women became pregnant during the clinical trials after being vaccinated, and the company is monitoring them.

The committee members drilled down on warning labels and instructions that would address anaphylaxis, after two British health care workers had severe allergic reactions immediately after their inoculations. The members were trying to strike a balance: providing reasonable cautions without alarming a public that already may be skittish about the vaccine. On Saturday, they were leaning toward advising that patients with “severe allergic reactions,” such as anaphylaxis, to any ingredient in the vaccine not get the shot.