U.S. vaccine approvals to undergo overhaul: what do the changes mean? 

Vaccines have been globally regarded as the pillar of infectious disease control and prevention. From development to their approval can take several years. Now, the FDA, the U.S. regulator overseeing vaccine approvals, has revealed a strict new process that could dramatically slow things down, citing claims that the COVID-19 vaccine was responsible for the deaths of at least 10 children. Moreover, a hepatitis B vaccine recommendation for infants has been scrapped. With public opinion split, experts warn that this could put vulnerable people at risk. 

While exact details about the proposed plans are yet to be announced, a memo written by the U.S. Food and Drug Administration’s (FDA’s) chief medical and scientific officer Vinay Prasad that had been leaked to the press, disclosed that the vaccine developers would need to provide more safety and efficacy data, delaying the time taken to get the vaccines to the public. 

New FDA vaccine approval process: Flu shots may need annual evaluations 

The proposed changes also include changing the process for how annual flu shots are greenlit. As the flu virus genetically evolves constantly, the vaccine is adapted annually to combat the new strains. While it’s typically a small tweak, these vaccines don’t get tested in a big trial. But now, the FDA is rethinking this. If it pushes for large-scale trials every year, it could cost more money and time, experts have said. Demetre Daskalakis, senior public health advisor at the Wellness Equity Alliance in California, pointed out that the yearly approvals will be challenging if the goal is to ensure that people get access to the flu vaccines on time. 

“It is not clear to me why there is a need to change the vaccine approval process since the FDA has historically worked closely with manufacturers to ensure that study designs yielded the safety and effectiveness data needed to allow the agency to make licensing decisions with confidence,” said Daskalakis, who is the former head of the Centers for Disease Control and Prevention’s (CDC’s) National Center for Immunization and Respiratory Diseases. 

Daskalakis also thinks that vaccine makers will be soon required to conduct more randomized control studies and to use saline placebos. 

“In many cases, such studies aren’t ethical if there is a standard of care vaccine available to protect subjects from preventable infections,” Daskalakis said. 

The FDA is also calling for tighter measures around approving vaccines for pregnant women, according to reports by the Washington Post. Pregnant people and babies are at a higher risk of being affected by viruses like COVID-19. A report by Mayo Clinic pointed out that pregnancy not just raises the risk of severe COVID-19, but that the risk goes further up with other health concerns like obesity, diabetes, high blood pressure, and lung disease. As severe COVID-19 can lead to death, the vaccine has been recommended for those who are pregnant or plan to be. 

Babies under the age of one are also at a much higher risk of being severely affected by the infection because they barely have immunity against the disease. While maternal vaccines protect them until around six months of age, COVID vaccines are approved for children older than six months to ensure continued protection, as it begins to decline. 

Hepatitis B vaccine recommendation terminated in the U.S. 

As the FDA mulls over the proposal, the CDC has ended a guidance recommending all newborns in the U.S. receive the hepatitis B vaccine. Now, it is up to the parents whether they wish to vaccinate their children, as long as the parents aren’t hepatitis B-positive themselves.  

Hepatitis B is a serious liver condition and infants and children who are infected tend to develop chronic disease – about 90% of infected infants and 30% of infected children aged between one and five. Vaccinations against the virus have been recommended for all infants in the U.S. since 1991. Since then, cases have massively dropped yearly from 18,000 to 20.  

Experts have warned that the U.S. could see a rise in cases following the new guidance, with some stating that it is not in the best interest of the infant.  

All this comes after an FDA probe linked the COVID shots to the deaths of at least 10 children. They died from heart inflammation, but much was not revealed about why the vaccines were to blame, the health conditions of the children, or the vaccine manufacturers involved.  

Currently, the three vaccines cleared in the U.S. are Moderna’s mRNA vaccine Spikevax, Pfizer and BioNTech’s mRNA jab Comirnaty, and Novavax’s protein-based Nuvaxovid. Moderna and Pfizer came out with statements reiterating the efficacy and safety of their vaccines.  

There was even speculation that the FDA would put black box warnings on these COVID-19 vaccines, but after critics slammed the idea, FDA head Marty Makary has now confirmed that the plan will not go through. Black box warnings are the FDA’s highest safety alert for medicines authorized by them, highlighting serious risks of taking said drugs. 

RSV therapies to be reviewed  

Besides, even therapies against the respiratory syncytial virus (RSV), which can be deadly if complications like pneumonia or bronchiolitis occur, are under scrutiny. Pharma companies, such as Merck, Sanofi, and AstraZeneca, all of which have RSV drugs on the market, were informed by the FDA that their drugs would be reviewed. 

While some health experts believe that these changes will delay drug development and could even put FDA vaccine approval on hold, William Soliman, chief executive officer (CEO) of the Accreditation Council for Medical Affairs (ACMA), thinks that these measures are meant to improve transparency. 

“For patients, these updates could improve confidence in vaccines, which let’s face it, we need right now,” said Soliman. “For pharma manufacturers, it will likely mean earlier integration of safety analytics, larger data requirements, and more robust follow-up studies. But the upside is that companies that invest in stronger evidence early will probably see smoother regulatory interactions later.” 

Soliman added that although the FDA’s accelerated approvals and emergency authorizations were designed to improve access for people, there is too much red tape. 

“Over the last five years, especially during and after the pandemic, what we are seeing is an unprecedented use of accelerated pathways and emergency authorizations. While these tools were essential at the time, they also highlight areas where the traditional approval framework needs some overhaul,” said Soliman. “The FDA is responding to two converging realities: the speed of scientific innovation and the increasing expectations for transparency from the public.” 

Anti-vaccine movement and proposed plans: is there a link? 

He pointed out that re-examining safety data does not imply that vaccines are unsafe. As vaccine skepticism is on the rise, some healthcare workers believe that these proposed changes are born out of it and could further lead to more mistrust.  

The U.S. Department of Health and Human Service (HHS) is currently headed by Robert F Kennedy Jr..Kennedy has made erroneous claims in the past about vaccines causing autism – which he demanded be mentioned on the CDC website – and COVID-19 being a “genetically engineered” virus. He was also a vocal critic of the CDC and the FDA prior to leading the HHS. 

Kennedy’s anti-vax stance drove the mRNA vaccine research funding cuts earlier this year. The HHS was stripped of $500 million, with over 20 projects, including ones dealing with bird flu and vaccine research, slashed. He also culled the CDC’s vaccine advisory committee in June. 

“The FDA is a regulatory body and must be independent of partisan politics. I fear that that is no longer the case. They need to show us the data supporting their claims and show their work to validate the as-of-yet unfounded concerns they have raised about these products in media interviews, unvetted presentations at advisory meetings, and leaked memos,” said Daskalakis.  

While the HHS spokesperson Andrew Nixon said that the FDA’s Center for Drug Evaluation and Research wants to “rigorously” review the available data and “ensure decisions remain rooted in evidence-based science,” healthcare experts believe the administration is falling short of these stated goals.  

“To be clear, it is important that any of these changes be scrutinized and held to the standard of science and transparency being promised by the FDA and HHS; that hasn’t been the case to date,” said Daskalakis. 

He added that the overhaul will instead create barriers to the development of new vaccines and may make the market less appealing to manufacturers. 

“I think we are already seeing a chilling effect on new vaccine products, which means that some diseases may not get new vaccines, and better vaccines may be delayed,” said Daskalakis. 

According to a survey by the financial institution Mizuho, the FDA was considered the biggest headwind for the therapeutics sector. The report revealed that backers want stability and consistency with regards to drug regulatory policies, which they think has been lacking of late. 

Although when these sweeping decisions will come into effect is not known, the axing of the hepatitis B vaccine recommendation happened unexpectedly, reversing decades of public health policy. 

Daskalakis said: “The FDA approved these products after rigorous review, so we should have a very high bar to roll back approvals of products that have had such a significant impact on the health of children (like, for example, RSV monoclonal antibodies). Show us the data. Use a transparent process.”