COVID-19

What HERO Members Need to Know About New Vaccines

Posted on by Daniel Richardson

While COVID-19 cases continue to surge across the United States, the race for the COVID-19 (SARS-COV-2) vaccine is nearing the finish line. Once the Food and Drug Association (FDA) determines that vaccines are safe and effective, they will likely be authorized through an Emergency Use Authorization. The FDA uses this type of approval during public health emergencies to authorize rigorously tested products quickly. But what many people do not realize is that vaccines also need to undergo a process known as post-market surveillance.

In this process, vaccine developers continue to monitor people taking approved medicines, vaccines, or medical devices after the product has been approved for use. One of the most important reasons for post-market surveillance is establishing further guidelines and recommendations for using drugs and vaccines. This information provides researchers with a better understanding of how the product works over time. If there seems to be a common side effect or negative reaction toward a drug or a vaccine, the FDA might alter the recommendations of the product.

It is common for guidelines and recommendations to change over time for products that have already been approved. Put simply, the post-market surveillance process keeps the public healthier by refining recommendations and making sure that guidelines for taking drugs or vaccines work for everyone.

Once an authorized vaccine for the COVID-19 virus is distributed to the public, the process of post-market surveillance will begin immediately. As required by the FDA, health care providers must report any side effects resulting from the use of approved medical products. For example, if a doctor, pharmacist, or authorized medical professional administers the vaccine to an individual who experiences a side effect after receiving the vaccine, they must report it to the FDA and the manufacturer.

Another way this happens is by vaccine recipients participating in surveys about their health over time. People working in healthcare will be first to get vaccines that are authorized by the FDA. HERO community members who get a COVID-19 vaccine will also have the opportunity to participate in this important long-term research. By participating in post-market surveillance research, HERO members can help researchers understand if there are differences in which types of vaccines work best for different people (men, women, older people, people with chronic diseases, etc.) and how the vaccines work to keep our communities healthy over time.

The COVID-19 pandemic is a once-in-a-generation challenge that healthcare heroes everywhere have worked together to face. From working on the frontlines to working behind the scenes, people in healthcare and clinical research roles have joined together with unprecedented focus to fight COVID-19. Post-market surveillance research is yet another important tool we will use to keep fighting.

If you are already a HERO member, thank you. If you are in a location that will have access to vaccines, you may be invited to participate in research next month. If you are not yet a member of the HERO registry, please join today. You can contribute to what it is like to work on the front lines of COVID-19, receive opportunities to participate in research, and help to protect all people working in health care as well as their families and communities.

 

For more information:

 

https://www.fda.gov/drugs/surveillance/postmarketing-surveillance-programs

 

https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01620

 

https://www.infectiousdiseaseadvisor.com/home/topics/prevention/vaccine-postmarketing-surveillance-demonstrates-continued-safety/

 

https://johner-institute.com/articles/regulatory-affairs/and-more/post-market-surveillance/

Deep Dive: A Closer Look at the Impact of School and Childcare Changes on Healthcare Workers

Posted on by dcridigital

As the COVID-19 pandemic continues to grip the U.S., the HERO Registry is shining a light on many of the challenges healthcare workers are facing. Similar to the the general population, healthcare workers who are are female and/or Latino or Hispanic are facing extra challenges when it comes to balancing work with changes in schools and childcare facilities.

We recently asked HERO members to identify how recent school and childcare changes have affected their ability to work. Of the 2,000 members that responded, 28% acknowledged feeling more distracted at work; 25% said they were more anxious because of school changes; 15% said they were struggling to find and pay for childcare; and 10% said they were unable to work the number of hours they need to work.

But a deeper dive into this HERO survey data shows differences when it comes to race/ethnicity and gender. Hispanic and Latino healthcare workers responding to the survey said that they were not available to work all the hours they needed to work at more than double the rate of white healthcare workers. Across all measures, healthcare workers who are Hispanic and Latino were more likely to report struggling with childcare issues than any other group.

A closer look at the HERO data also shows that while male and female healthcare workers are showing similar rates of not being able to work all hours needed and struggling to find childcare, women were more likely to identify with being distracted and more anxious while working than men.

What’s Next?

We appreciate the input from the HERO Community who help inform our research by completing our Hot Topic survey. Your participation helps bring awareness to the challenges healthcare workers are facing.

If you are not a HERO member, please join today. You can contribute to what it is like to work on the front lines of COVID-19, receive opportunities to participate in research, and help to protect all people working in health care as well as their families and communities.

Pauses in Vaccine Trials Build Trust and Show the System is Working

Posted on by dcridigital

Adrian Hernandez, MD, MHS, HERO Research Program principal investigator, recently shared his opinion in STAT News on the recent pauses of three COVID-19 vaccine trials.

“Holds and pauses certainly aren’t restricted to COVID-19 trials in the clinical trials sphere,” says Hernandez. “I believe that these three pauses show that the system is working.”

The goals of vaccine trials are to show a therapy is safe and effective in preventing infection. And in the era of COVID-19, researchers need to prove this in an extremely compressed timeline. What would typically take several years is now happening over several months.

With an accelerated timeline, confidence in the regulatory approval process is critical to willingness by the public to get vaccinated. A recent STAT-Harris Poll shows that Americans are less willing now to get a COVID-19 vaccine than they were a few months ago. In mid-August, 69% of Americans said they would get a vaccine once available. Asked again in October, only 58% said they would get vaccinated. The lack of interest was especially evident in Black individuals — 65% were interested in the first poll but only 43% in the second poll.

Hernandez shares how these recent holds in vaccine trials can help establish trust in the research system and acceptance when a vaccine is approved.

“It tells the American public that everyone is committed not just to developing new treatments, but to developing ones that are safe and effective. It also reassures current and future participants about taking part in studies of these new treatments that everyone is treating safety as a primary concern.” To read Hernandez’s entire opinion, visit STAT News.

Dental Professionals are on the Front Lines of COVID-19 with High Exposure to the Virus

Posted on by dcridigital

October is National Dental Hygiene Month — a time to acknowledge and thank dental hygienists and their colleagues who strive to brighten our smiles during this global pandemic.

Dental professionals along with other healthcare workers are at high risk of exposure to COVID-19 due to proximity to patients as well as to other workers. Dental practices were initially shut down for routine practice at the start of the pandemic. But today, many dental professionals have returned to work.

Based on an article in The New York Times and occupational information from O Net, dental hygienists face high exposure to disease and infection and physical proximity to other people. Although slightly less than hygienists, dental assistants and dentists also face high daily exposure and proximity.

Why are dental professionals at so much risk?

If you have had your teeth cleaned, you are familiar with the variety of instruments used in a dental office. These instruments create sprays of tiny droplets and aerosols containing not only water, but saliva, which could contain high levels of the virus in infected people. These particles can stay in the air for hours, be transmitted to others, and land on hard surfaces. Combine this with the fact that dental professionals are in close proximity to their patient’s face, and you can easily understand how this group faces particularly high risk.

“I can’t express enough how dangerous it is in a dental office right now, we have the ability to be asymptomatic and spread this to other people as much as we’re looking out for our own safety,” said Cindi Roddan, a dental hygienist, in a NBC Bay Area Investigation, “Everything that we do in dentistry creates aerosols. It is so dangerous.”

Coming together to fight COVID-19

Dental professionals along with all people who work in health care are invited to join the HERO Registry. HERO members share what it is like to work and live during the COVID-19 pandemic and have opportunities to participate in research to help protect and support all healthcare workers during this pandemic.

Join HERO today, share this flyer, and invite your colleagues to do the same.