Vaccine makers face 'major regulatory shift' in the US this week

Shares of vaccine makers dropped on Monday as investors await the results of a key meeting this week by a committee for the Centers for Disease Control and Prevention (CDC) that appears likely to result in a seismic shift in childhood vaccination schedules.

The CDC's Advisory Committee on Immunization Practices (ACIP) is set to meet on Thursday and Friday and will reportedly recommend to delay a shot normally administered to newborns at birth. However, the meeting is also shrouded in mystery, with an agenda that is short on details, indicating only that there will be "votes" happening at the end of the meeting's first day.

But Bernstein analyst Courtney Breen wrote in a client note on Tuesday that "shock waves are expected at the ACIP meeting this week” and that Dr. Vinay Prasad, head of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research, "signaled a major regulatory shift" in an internal memo.

PBS news correspondent Ali Rogin reported on Prasad's memo in a post on X, noting that he said the US Food and Drug Administration (FDA) "will acknowledge that COVID-19 vaccines have killed American children,” calling it a "profound revelation."

According to Rogin, Prasad indicated in his memo that "we will take swift action regarding this new safety concern" and "will demand pre-market randomized trials assessing clinical endpoints for most new products."

Prasad has not presented any evidence that the Covid-19 vaccine is responsible for killing children in America, raising concerns among medical professionals.

Dr. Paul Offit, an infectious disease specialist at Children’s Hospital of Philadelphia and co-inventor of a rotavirus vaccine, said that Prasad is "making a fairly fantastic statement” and that he “should provide extraordinary evidence that that's clear, and he didn't, which is incredibly irresponsible and unprofessional to do."

Drugmakers face unprecedented headwinds in the US

Prasad, who is the FDA's top vaccine regulator, was a vocal critic of the agency's health policies on his (now inactive) X account before being picked for the role by Health Secretary Robert F. Kennedy Jr., who is himself a vocal critic of vaccines.

Although Prasad is a skeptic about the Covid-19 vaccine for children, he has also called it "a miraculous, life-saving advance," as Axios reported.

Shares of some of the biggest vaccine makers all plunged on Monday as investors brace for the results of the ACIP meeting this week.

Moderna (MRNA) fell 5.5%, BioNTech (BNTX) was down 4.2%, Novavax (NVAX) dropped 4%, and Pfizer (PFE) declined 1.8%.

All four stocks have sunk this year as the drugmakers face a much more difficult regulatory environment with Kennedy at the helm of the FDA and Prasad leading vaccine regulations.

Shares of MRNA have plunged 42.1%, BNTX is down 14.6%, NVAX has dropped 17.9% and PFE shares have slipped 5.2%.

Any decisions made by ACIP are not legally binding, "but they have profound implications for whether private insurance and government assistance programs are required to cover the vaccines," as The New York Times reported.

This could have a significant impact on vaccine stocks as the companies might face very difficult decisions on pricing going forward if private insurers choose to no longer cover the drugs.

Rogin noted on X that Prasad is also looking to revise the annual framework for the flu vaccine, which he reportedly called "an evidence-based catastrophe." He said in his memo that anyone who disagreed with the new direction the FDA is taking should resign.