WASHINGTON (NYTIMES) – An independent committee of experts advising the Centres for Disease Control and Prevention on Saturday afternoon (Dec 12) voted to recommend the Pfizer coronavirus vaccine for people aged 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 authorisation of the vaccine by the Food and Drug Administration.
The advisory committee has been engaged in many marathon-length sessions this fall to discuss a plethora of knotty issues surrounding the introduction of the novel vaccine, which is in limited supply, during a pandemic.
In meetings on Friday and Saturday, the panel’s heated discussions centred 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.
Pregnant women were not included in clinical trials of the vaccine.
The expert panel’s discussion about pregnancy centred on the fact that at least 330,000 healthcare 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 members drilled down on warning labels and instructions that would address anaphylaxis, after two British healthcare 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.
On the issue of whether to permit the vaccine for 16- and 17-year-olds, several paediatricians on the committee expressed concern that Pfizer’s data so far with respect to the youngest participants was “thin”.
But other committee members pushed back, saying that the physiological difference between a 16-year-old and an 18-year-old was minimal.
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