Safety Concerns Challenge Presidential Candidate Vaccine Program

As COVID-19 continues to dominate the political background of the 2020 presidential election, the candidate’s plans to promote public health and ultimately distribute vaccines as voters move towards voting are very important. It has become.

For former Vice President Joe Biden, the decision on vaccine safety and efficacy should be left to us Exclusively In the hands of scientists.his platform Has stated that clinical trial data for vaccines approved by the Food and Drug Administration will be released and will invest $ 25 billion in the manufacture and distribution of vaccines.

Biden said Americans would be able to get the vaccine for free, is not Explicitly target the date on which the vaccine should be approved.

President Donald Trump also plans to make a future vaccine No cost But in contrast to Biden, it promises production and distribution 300 million times Vaccines by January 2021.

To accelerate the process, government agencies such as the Department of Health and Human Services Supported Manufacture of vaccine candidates prior to final approval. This precautionary step allows for faster distribution once the vaccine is ultimately considered effective and approved for use.

Dr. Anthony Fauci MD ’66 Said By the end of December or the end of January, he is “carefully optimistic,” saying “at least one, and in some cases, two or more vaccines will give a positive answer.” Such a timeline (about a year after the coronavirus was first identified) makes the development of the COVID-19 vaccine one of the fastest in history.

However, competition to deploy the vaccine has been triggered. Concerns Among the general public about whether a fast-tracked timeline comes at the expense of safety or effectiveness.

The government’s professor Sarah Krebs told Sun that vaccine hesitation (the willingness of those to accept an approved vaccine) will be a key factor in determining the extent of the spread of COVID-19, especially after the final approval of the vaccine. Told. Expansion of vaccine repellent movement..

Krebs and her research team include public health and medical professionals, Survey It asked American adults about the effectiveness of the vaccine, the risk of side effects, and how the term of protection shaped the tendency to vaccinate. The study also looked at the effects of factors such as vaccine approval by government agencies and political leaders, FDA approval levels, and the country of origin of vaccines.

“The timeliness of vaccine development and availability is not the only obstacle from a public health perspective,” the study writes. “Once a vaccine is developed, a sufficient proportion of the population needs to be vaccinated to reach herd immunity and prevent its spread in the community.”

The findings reveal the effectiveness of the vaccine, which is one of the core factors of vaccine hesitation.

“This finding isn’t all that surprising, because … it’s one of these intuitive things, and the effectiveness of the vaccine is very important,” Krebs said. “And that also applies to other vaccine studies — people don’t want to take vaccines that don’t work.”

According to Kreps, as the effectiveness of the vaccine increased from 50% to 90%, the number of people willing to get the vaccine increased by about 16%.

In addition to the potential vaccine efficacy, Krebs and her colleagues said politics can play an important role in influencing the general acceptance of vaccines. For example, an FDA emergency license was associated with reduced vaccination motivation when compared to full FDA approval.

One of the public issues in Trump’s vaccine program is Emergency use permission, If certain conditions are met, the FDA will be allowed to release a medical product without complete evidence of its efficacy and safety.

The EUA has been deployed in many outbreaks to date, including the 2009 H1N1 influenza pandemic, but its use has been Increasing controversy After the FDA first approves — and then Canceled — Urgent approval for the use of chloroquine and hydroxychloroquine drugs in the treatment of COVID-19.

“There’s nothing inherently wrong with the adoption of the EUA,” Krebs said, but the drug withdrawal previously endorsed by Trump has led to increased distrust of the process.

“One of the challenges of how the Trump administration dealt with it, he says, is that no one has pushed the FDA harder than he does,” Krebs said. “This is really like politicizing the vaccine process.”

An important finding from the study was that the politicization of the vaccine development process elicited skepticism from the American public regarding potential diminished confidence in vaccines, Mr. Krebs said.

“Even if it takes time, going through a complete FDA approval process actually results in longer-term support and, frankly, reveals some of these potential Phase 3s. .. [clinical trial] The challenge is that if they become a real problem, they can really backfire in terms of confidence in the vaccine, “Krebs said.

According to Krebs, Americans are most likely to trust the vaccine when the influence of the faction is minimal. Respondents were least likely to choose a vaccine approved by Trump, but this result was not so high with the vaccine recommended by Biden.

In contrast, vaccine approval by the US Centers for Disease Control and Prevention and the World Health Organization was associated with a much higher chance of accepting the vaccine, according to Krebs.

“Our main conclusion is that political leaders should not participate in this debate and leave it to public health authorities,” Krebs said. “”[These organizations are] Being considered on top of political conflict, it is much more likely to elicit the kind of credibility and credibility needed to produce a wide range of vaccinations. “