vaccine

WASHINGTON — President Trump’s pick to lead the Food and Drug Administration voiced support for the safety of long-established vaccines at a hearing Thursday, even as senators questioned her about the White House’s efforts to upend childhood immunizations.

Dr. Heidi Overton, a physician serving as a White House adviser, has worked on a series of Trump health initiatives, including an executive order last month that called for splitting up and spacing out decades-old childhood vaccinations. Overton stood beside Trump in the Oval Office when he falsely remarked that the combined measles, mumps and rubella, or MMR, vaccine is “quite lethal.”

Senate Health Committee Chairman Sen. Bill Cassidy, a physician from Louisiana, pushed Overton to reject that statement and affirm the safety of FDA-approved vaccines.

“Right now every vaccine that is on the market has been determined to be safe and effective,” including the MMR vaccine, Overton said.

Cassidy repeatedly has tried to extract commitments from Trump health nominees to uphold vaccine standards, including from Health Secretary Robert F. Kennedy Jr., only to see the Republican administration push forward with efforts undermining their use.

“Kennedy gave me guarantees, and he did not keep them,” said Cassidy, a Republican. “If the president asks you to do something that goes against those guarantees you give us today, what will you do?”

Overton said she would “follow the statutory requirements” for FDA commissioners and give Trump her best advice.

If confirmed by the Senate, Overton would inherit a raft of other controversial projects at the agency, including a safety review of the nation’s principal abortion drug and new rules that make it easier to sell flavored electronic cigarettes. Both issues were a focus for Republicans and Democrats on the panel, who will vote on Overton’s nomination.

Overton sidesteps past statements on abortion pill

The FDA approved the abortion pill mifepristone in 2000 and repeatedly has affirmed its safety while broadening access, including allowing it to be sent through the mail. But Kennedy ordered an FDA review of the drug’s safety last year, following calls from antiabortion groups and lawmakers favoring abortion restrictions.

While working at the Trump-aligned America First Policy Institute, Overton called the FDA decision to allow mail delivery of mifepristone “dangerous for women,” referring to the practice as “chemical abortion on demand.”

In response to questions from Washington Sen. Patty Murray, Overton sidestepped her personal views on the drug, stating that it “has met the safety and efficacy determinations of the FDA.” Overton said she didn’t want to “prejudge” the FDA’s safety review of the pill.

“The FDA has said this is safe,” responded Murray, a Democrat. “We need someone in FDA to make sure this is done by science.”

Overton’s abortion views could complicate her efforts to win over two moderate Republicans on the panel: Maine Sen. Susan Collins and Alaska Sen. Lisa Murkowski. Both have bucked their party on the issue, supporting federal access to abortion. Collins is locked in a tight reelection race in which abortion access is a central issue.

But Collins focused her questions Thursday on a different issue: recent FDA decisions allowing new flavored e-cigarettes onto the market. Under previous administrations, including Trump’s first term, the agency had restricted sweet flavors that appeal to kids.

Overton pointed out that approval of the fruit-flavored products had the backing of FDA scientists, who determined the products met the standard of “appropriate for the protection of public health,” by helping adult smokers quit cigarettes.

“They believed that standard was met because so many adult smokers are using flavors preferentially,” Overton said.

To become commissioner, Overton will need a majority of votes from the 21-member health committee, followed by a positive vote from the full Senate.

Under the current administration, leading the agency has involved balancing Trump’s demands for slashing regulations — such as those for vaping products — alongside Kennedy’s interests in scrutinizing vaccines, drugs and food ingredients.

The previous FDA head faced numerous challenges before quitting

Those challenges dogged the tenure of the previous FDA head, Dr. Marty Makary, who resigned in May. Makary’s time at the agency was defined by scientific disputes, leadership changes and a string of media stories detailing low morale and internal dysfunction among staffers. The FDA has lost about 20% of its employees to layoffs, buyouts, retirements or resignations since Trump took office.

Overton studied under Makary at Johns Hopkins University, where she received a doctoral degree in clinical research after earning her medical degree at the University of New Mexico.

Like Makary, Overton has no experience running a large bureaucracy, a critical skill for steering the FDA’s 16,000 staffers spread across numerous U.S. and international locations.

In financial disclosure forms, Overton reported no investments in healthcare or food companies. That’s a stark contrast to Makary and other recent FDA nominees who have had to divest investments or cut other financial ties with companies regulated by the FDA.

Overton reported $50,000 to $100,000 in student loans.

Perrone writes for the Associated Press.

50,000 frontline staff to receive a jab for a different Ebola strain, with 20,000 enrolled in a one-year clinical trial.

Health workers in parts of the Democratic Republic of the Congo (DRC) have begun to receive a vaccine that many hope will provide a level of protection against the Ebola virus.

The vaccine rollout started on Saturday in Bunia, the capital of Ituri province in the northeastern DRC. Ituri is the epicentre of the fastest-growing outbreak of Ebola in history.

The provincial governor, Major-General Gaby Kasongo Mulumba, said health workers there “are particularly exposed and deeply involved in the response”.

The operation, backed by the World Health Organization and Doctors Without Borders, known by its French initials MSF, will also target North Kivu, where cases have been rising sharply, health authorities said.

Some 50,000 health and other frontline workers will be injected with the Ervebo vaccine, which was developed for use against the more common Zaire strain.

Its effectiveness against the current Ebola strain caused by the Bundibugyo virus will be monitored in 20,000 recipients for up to one year.

Clinical trials are ongoing to find a licensed vaccine for the latest outbreak, which has no licensed vaccine or proven treatment.

“We don’t know to what degree it might be effective against the Bundibugyo strain,” Steve Ahuka, a Congolese official who is part of the health task force against the Ebola outbreak, said.

Dr Jeannot Elua said at a health facility in Bunia the vaccine was “beneficial”.

“We healthcare workers don’t really have a choice. We are going to receive it,” he told the Associated Press news agency. “Some people here had already received the previous vaccine. I received it myself, because it was mandatory.”

WHO experts have said that early data on the Ervebo vaccine, notably from animal trials, suggested it could offer some protection in the current outbreak.

The virus has killed at least 3,639 and infected some 7,541 people since May. Some 1,823 people have recovered, according to the latest figures from local authorities.

The WHO said in August that 70,000 doses of Ervebo were approved for use in the DRC.

The vaccine is being used under a compassionate-use programme, which allows a medical product to be used in a serious disease situation even though it has not been specifically approved for that particular use.

While WHO officials have cited “encouraging signs” that transmission may be slowing, MSF warned on Friday that there is no clear evidence the epidemic is coming under control.