FDA to authorize the use of the Pfizer COVID-19 vaccine for those ages 12-15 as early as next week, The New York Times reports

pfizer vaccine
Vials of the Pfizer-BioNTech COVID-19.

  • The FDA is reportedly set to OK the Pfizer COVID-19 vaccine for 12- to 15-year-olds by next week.
  • Pfizer said in March that its vaccine was highly effective in a trial of over 2,000 adolescents.
  • Nearly 150 million Americans had gotten at least one dose of a vaccine as of May 3, CDC data showed.
  • See more stories on Insider’s business page.

The Food and Drug Administration is set to authorize the use of the Pfizer-BioNTech COVID-19 vaccine for adolescents aged 12-15 years old as early as next week, The New York Times reported Monday.

Following FDA authorization, an advisory panel from the Centers for Disease Control and Prevention will review data and results from clinical trials to draft recommendations on the use of the vaccine for those 12-15 years old, according to The Times report.

Pfizer announced in late March that their vaccine was highly effective in a trial of more than 2,000 adolescents, and the vaccine was “well tolerated” among those ages 12 to 15. Pfizer said the side effects of the vaccine experienced by those ages 12-15 were similar to those ages 16 to 25.

The CDC opened up vaccine eligibility to people who were 16 years or older in April, and those who were 16- or 17-years-old were only allowed to receive Pfizer while those 18 and up are authorized to receive Moderna or Johnson & Johnson.

Pfizer CEO Albert Bourla said in a March statement the company shares the “urgency to expand the authorization of our vaccine to use in younger populations.” He said he hopes that the clinical trial data will prompt officials to start vaccinating the age group “before the start of the next school year.”

An FDA spokeswoman declined to comment to The Times on the agency’s timeline of authorizing the vaccine for adolescents.

“We can assure the public that we are working to review this request as quickly and transparently as possible,” the spokeswoman told The Times.

Nearly 150 million Americans have received at least one dose of a COVID-19 vaccine as of May 3, according to data from the CDC, equating to roughly 44% of the US population.

Read the original article on Business Insider

The Biden administration is reportedly weighing restrictions on nicotine in cigarettes and a possible menthol ban

smoking cigarette
Most youths who smoke use menthols, according to the CDC.

  • The Biden administration is mulling major changes to tobacco policy, The Wall Street Journal reported Monday.
  • Officials are considering a ban on menthol cigarettes, the paper said.
  • New rules may also require tobacco firms to lower the amount of nicotine in their products, according to the report.
  • See more stories on Insider’s business page.

The White House is mulling sweeping changes to government tobacco rules, The Wall Street Journal reported Monday, citing unnamed people familiar with the matter.

The Biden administration may compel tobacco and cigarette companies to slash the amount of nicotine in cigarettes sold in the US to levels that are less addictive, the paper said, adding that a ban on menthol cigarettes is also being considered.

Shares of major tobacco companies fell sharply following the Journal’s report, with Altria Group dropping more than 6% before markets closed. British American Tobacco dropped about 3.3%, and Phillip Morris dropped about 1.6%.

The goal of a ban on menthol cigarettes would be to curb smoking among young people, the Journal reported. A majority of people aged 12-17 who smoke use menthol cigarettes, according to the Centers for Disease Control. The US Food and Drug Administration has said it will decide whether to take action on menthol cigarettes by April 29, following a civil petition that was filed several years ago.

By drastically reducing the overall levels of nicotine in cigarettes, the administration aims to make them less addictive and promote less dangerous alternatives like lozenges or e-cigarettes, according to the Journal.

The White House did not immediately return Insider’s request for comment. An FDA spokesperson declined to comment.

Nicotine is the addictive component in tobacco products, but it’s not what makes them deadly, according to the FDA. It’s the mix of chemicals found in cigarettes that causes serious lung diseases like cancer and chronic obstructive pulmonary disease, the agency says.

According to the FDA, tobacco use causes more than 480,000 deaths in the US each year. It increases the risk of stroke, is a major cause of cardiovascular disease, and accounts for one in three cancer deaths in the US.

Read the original article on Business Insider