CDC group recommends Pfizer vaccine for patients as young as 16

Dec 13, 2020 Travel News

CDC group recommends Pfizer vaccine for patients as young as 16

An independent panel of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted in favor of Pfizer’s coronavirus vaccine for people 16 and older. This approval, which is now only awaiting final approval from Dr. Robert Redfield, the director of the CDC, is a key signal to hospitals and doctors that they should proceed with inoculating patients.

The approval follows authorization for emergency use of the vaccine on Friday evening by the Food and Drug Administration, which oversees the approval of medical products.

The advisory committee, which typically meets three times a year to review changes to routine immunization schedules for children, adolescents and adults, has participated in numerous marathon sessions this fall to discuss a plethora of thorny issues surrounding the introduction of the new vaccine. , which is in limited supply, during a pandemic.

During the Friday and Saturday meetings, the lively panel discussions focused on three areas: whether to recommend the vaccine to 16- and 17-year-old patients, to pregnant and breastfeeding women, and to patients who have had an anaphylactic reaction to others. vaccines.

CDC officials and scientists will review the debate and publish more specific advice on these and other specific groups on Sunday and in the weeks to come, as more information about the vaccine becomes known.

Shipments of nearly three million doses of the vaccine will begin shipping to states this weekend. Most states should follow CDC guidelines for reserving these doses for healthcare workers and residents of nursing homes and long-term care facilities.

Pregnant women have not been included in clinical trials of the vaccine. The expert group discussion on pregnancy centered on the fact that at least 330,000 health workers in the first cohort of vaccinees should be pregnant or breastfeeding women. Although the committee insisted that the decision to get the vaccine be left to pregnant women in consultation with their doctors, it also suggested that they weigh their personal risk of exposure to the virus against the effectiveness of the vaccine. and the lack of data on pregnancy.

The Committee noted that, as it is not a live virus vaccine, it is not considered to be a risk to a nursing infant.

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

Committee members looked at warning labels and instructions that would address anaphylaxis, after two British healthcare workers had severe allergic reactions immediately after their inoculations. Members were trying to strike a balance: providing reasonable warnings without alarming an audience that might already be nervous about the vaccine. On Saturday, they leaned in to advise that patients suffering from “severe allergic reactions”, such as anaphylaxis, to any ingredient in the vaccine do not get vaccinated. Additionally, they recommended that patients generally be monitored for 15 minutes immediately after being vaccinated and, for those with a history of anaphylaxis, 30 minutes.

On whether to authorize the vaccine for 16- and 17-year-olds, several pediatricians on the committee expressed concern that Pfizer’s data to date on the youngest participants was “thin.”

But other committee members pushed back, saying the physiological difference between a 16-year-old and an 18-year-old was minimal. People under the age of 18 who work in long-term care facilities and “essential” jobs such as grocery store clerks are at high risk of contracting the virus and would likely be recommended for first vaccines, they said. declared.

Doctors noted that these teens could be disproportionately people of color. By excluding them, the doctors argued, the committee would inadvertently discriminate against them on the basis of their age.

And, as they added, because the data on side effects and effectiveness are so positive, the risk for teens of contracting the virus – as well as spreading it and having their schooling disrupted – outweighed on the known risks of the vaccine itself.

The committee also expressed support for offering the vaccine even to people who have already tested positive for the virus. But given currently limited stocks, they urged those who had been infected within 90 days to wait until that period was over.

The CDC is expected to release more specific clinical advice on Sunday. In addition, it has published an extensive “toolkit” for providers and patients, intended to provide extensive information to address potential concerns.