Label Warning for Pfizer and Moderna

by Abby McVay | Jul 8, 2021 | Coronavirus, COVID-19, FDA, Labels, Vaccine

medical vials and syringe

Last week, the FDA announced that Pfizer-BioNTech and Moderna will require warning labels for vaccines for young adults and adolescents that are susceptible to rare heart inflammations.

Pfizer and Moderna both faced backlash earlier this year over rarer but extremely severe cases of blood clots, which led to multiple fatalities. After investigations, Johnson & Johnson’s vaccine carries a warning label in the United States.

The ruling to add the warning label comes in direct response to reports of younger adults, especially males, developing heart inflammation. Most of the reports came after the second dose of the mRNA vaccine. The Centers for Disease Control and Prevention, or CDC, stated that over 310 individuals were hospitalized, with only 14 being discharged so far. There have been no reported deaths related to this incident.

Individuals who received the Pfizer vaccine accounted for more of the heart inflammation cases, which is largely due to the FDA’s approval of the shot for those age 12 and over. Moderna and Johnson & Johnson’s vaccines have yet to be FDA-endorsed for individuals under 18. Pfizer vaccine has also come under scrutiny in Europe and Israel for these side effects.

Both Pfizer and Moderna released similar statements, outlining that they and the CDC still encourage vaccinations for eligible individuals and that they will work closely with the FDA and other regulatory authorities on the next steps.

The CDC concluded that the benefits of the vaccines still outweigh the possible risks. The verdict could compel individuals with apprehension to favor other vaccines, like Johnson & Johnson or AstraZeneca¹.

EMMA International has been staying on top of all the breaking COVID-19 news, including the unprecedented regulatory changes. Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!

¹Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk, FDA says. (2021, June 24). FiercePharma. https://www.fiercepharma.com/pharma/fda-says-label-warning-coming-for-heart-inflammation-pfizer-bnt-moderna-covid-19-vaccines

‌

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.

Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...

Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

See All Resources

Ready to learn more about working with us?

Diverse businesspeople gathered together for negotiations lead by african businesswoman

Pin It on Pinterest

Share This