So when we look at these systems, we’re able to see signals that pop up if they’re there. We can also look to see whether vaccines are associated with certain adverse events. And this is ongoing. It’s not like something that happens once and then we’re done. It’s an ongoing process. Because once a vaccine is out there, it’s out there. We need to keep monitoring what’s going on. And if something pops up, we need to figure out whether it’s real or not.
What about the accusations that the FDA is approving vaccines too quickly, particularly in the context of the Covid-19 pandemic?
I would say that the FDA has very high standards for the approval of vaccines. And we have not deviated from those standards. The Covid-19 vaccines were approved in a very expeditious way, but they were approved because the data supporting their efficacy and safety were robust. And the benefit of getting the vaccines out there far outweighed any potential risk that we could see.
And in fact, with Covid, we’ve seen very few potential signals that have popped up that have been related to the vaccines. And we’ve been able to address them very, very quickly.
So I would say that the FDA has a very high bar for approval, and we’re not going to lower that bar. If anything, I think we’re going to keep that bar high, because we want to make sure that the vaccines that are out there are as safe and effective as they possibly can be.
Finally, what would be your message to individuals who are hesitant about getting vaccinated?
My message would be: please ask questions. Be informed. But get your information from reliable sources, like the CDC, the FDA, the World Health Organization, and your health care provider. Don’t rely on social media for your information. Don’t rely on the neighbor down the street who heard something from somebody else. Go to the source.
And if you have concerns, talk to your health care provider. They can answer your questions. They can provide you with the information you need to make an informed decision about vaccination. Because ultimately, vaccination is one of the most important public health tools that we have. It’s been proven time and time again to be safe and effective. And it’s really the best way that we have to protect ourselves and our communities from infectious diseases.
It’s important to remember that vaccines have saved countless lives and prevented countless illnesses. And that’s the goal that we all have: to keep ourselves healthy, to keep our families healthy, and to keep our communities healthy.
The transparency and collaboration between different agencies involved in vaccine safety is crucial in ensuring the public’s trust in the vaccination process. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), explained in a recent interview how the system works to monitor and address any potential adverse events associated with vaccines.
Marks highlighted that the monitoring of adverse events is a continuous process that involves comparing vaccinated populations with unvaccinated populations to identify any potential risks. This process has been effective in the past, as seen with the Janssen Covid vaccine, which was swiftly withdrawn from use after the identification of a serious adverse event known as thrombotic thrombocytopenia syndrome. This demonstrates the system’s ability to detect and respond to safety concerns in a timely manner.
Critics of vaccines often raise concerns about the lack of placebo-controlled double-blinded trials for new vaccines. However, Marks clarified that initial Covid vaccines were indeed tested in such trials. He also explained that when a vaccine becomes the standard of care, it is not ethical to test it against a placebo. Instead, new vaccines are often tested against existing ones to determine their efficacy and safety.
When it comes to safety testing, there is no compromise. Marks emphasized that a robust safety data set is required before a vaccine can be approved for use. The bar for safety in vaccines is set high, as there is little tolerance for risks when administering vaccines to healthy individuals.
The process for approving vaccines for children also involves ensuring their safety in adults first before moving on to pediatric populations. The urgency to approve Covid vaccines for children increased with the emergence of the Omicron variant, highlighting the importance of assessing the direct clinical benefit to children before widespread deployment.
The follow-up work done after vaccines come to market is equally important. The recent potential signal of Guillain-Barré syndrome with some RSV vaccines is being closely monitored, with advisory committees like the Advisory Committee on Immunization Practices taking a conservative approach until more data is available.
Overall, the collaboration between agencies like the FDA and the ACIP, along with the focus on vaccine safety, ensures that vaccines are rigorously evaluated for efficacy and safety before being recommended for use. The shared information and ongoing monitoring of adverse events contribute to maintaining public trust and confidence in the vaccination process. The discussion surrounding the Guillain-Barre syndrome (GBS) risk associated with RSV vaccines has sparked concerns among the public, particularly those who are already hesitant about vaccines. However, it is crucial to be transparent about these issues and address them head-on.
It is essential to educate people about the fact that while there are small risks associated with vaccines, the benefits far outweigh these risks. Vaccines undergo rigorous testing and are only approved if the potential benefits of preventing serious illnesses or deaths outweigh any potential adverse effects.
One of the challenges lies in explaining the concept of benefits across the population versus the risk to the individual. For example, with COVID-19 vaccines, the chance of experiencing a serious adverse event is incredibly small, while the potential benefits, especially for older individuals, are significant in preventing severe illness or death from the virus.
When considering diseases like measles, the importance of vaccination becomes even more apparent. Measles is a highly contagious disease that can be fatal, especially in children. Before the measles vaccine was available, thousands of children died from the disease each year. The rare risks associated with the measles vaccine, such as febrile seizures or blood clotting disorders, are outweighed by the lives saved through vaccination.
It is crucial to weigh the potential risks of vaccines against the benefits of preventing deadly diseases. By being honest and transparent about the risks and benefits of vaccination, we can help people make informed decisions and feel confident in the use of vaccines. The small risks associated with vaccines are far outweighed by the significant benefits they provide in protecting individuals and communities from infectious diseases.
