Pfizer-BioNTech coronavirus vaccine gets full FDA approval. Moderna’s full approval under FDA review

Industry News

Pfizer-BioNTech coronavirus vaccine gets full FDA approval. Moderna’s full approval under FDA review 

August 2021

The Food and Drug Administration (FDA) recently granted full approval to the Pfizer-BioNTech coronavirus vaccine for people ages 16 and older. The Moderna vaccine is currently under the full FDA review process and is expected to receive the same status very soon.

The two vaccines have been operating under Emergency Use Authorizations (EUA), which allows them to be distributed without FDA approval. Just as companies have to apply for EUAs, they also have to apply for FDA approval. Part of the timeline for approval depends on when a company asks the FDA to consider their vaccine. Pfizer became the first company to apply for full FDA approval in May, followed by Moderna in June. Johnson & Johnson has not submitted its application yet but said it has plans to do so before the end of the year.

The FDA approved the Pfizer vaccine at the end of August, about four months after the company submitted its application. The vaccine is approved for two doses, three weeks apart, in people 16 and older. It remains available under emergency use authorization for adolescents ages 12 to 15. It’s possible Moderna could receive full FDA approval in about a month for people 18 years and older.

Janet Woodcock, the acting FDA commissioner, said in a statement that the public can be very confident that the FDA-approved Pfizer-BioNTech coronavirus vaccine meets the high standards for safety, effectiveness and manufacturing quality that is required for a fully authorized product. With the full FDA-approval of this vaccine, the hope is that people who are hesitant to get a vaccine will now feel safer receiving an inoculation – especially in light of the highly contagious and lethal Delta variant which is surging throughout the U.S.

According to a report by the Kaiser Family Foundation, “almost all (more than 9 in 10) COVID-19 cases, hospitalizations, and deaths have occurred among people who are unvaccinated or not yet fully vaccinated. The good news is a Harris Poll survey recently found that 80 percent of Americans who were aware of the approval now have more confidence in it. Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

National Immunization Awareness Month

National Immunization Awareness Month (NIAM) is a yearly observance in August to highlight the importance of vaccinations for people of all ages. The goal of NIAM is to raise awareness about the important role vaccines play in preventing serious, sometimes deadly, diseases.

Vaccines play a critical role in reducing the spread of, and, in some cases, eliminating the threat of the world’s many devastating infectious diseases like COVID-19. Vaccines are used to boost the body’s immune system and defend itself against diseases such as influenza, tetanus, diphtheria, mumps, measles, chickenpox, shingles, whooping cough, meningitis, smallpox and polio. Most of these infections can cause serious or life-threatening illnesses and may lead to life-long health problems. Because of vaccines, many of these illnesses are now rare. A study released this year in the Lancet shows that vaccines against 10 major diseases prevented 37 million deaths between 2000 and 2019 in low- and middle-income countries worldwide and that vaccinations are also projected to prevent a total of 69 million deaths between 2000 and 2030.

Advancements in biotechnology have made it possible to produce safe and effective vaccines to fight infectious agents, improve existing vaccines, and increase the amount of vaccines that can be produced. As of April 2020, there are nearly 260 vaccines in development by U.S. biopharmaceutical companies to both prevent and treat diseases including HIV, certain types of cancer, SARS, Zika, Ebola, Alzheimer’s disease, allergies, autoimmune disorders and many more. These vaccines offer significant hope for the future. The key is to continue providing affordable access to effective vaccines for everyone who could benefit from them.

As the COVID-19 pandemic continues to surge and with flu season right around the corner, it’s more important than ever to learn the facts about immunizations and get vaccinated. Learn more by visiting the CDC website.

For more information, contact Patty Cooper with the California Biotechnology Foundation at 916-764-2434 or patty.cooper@cabiotech.org.