NEW! U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults
The Food and Drug Administration (FDA) has cleared the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), for emergency use authorization (EUA). The Novavax COVID-19 Vaccine, Adjuvanted , is a protein-based vaccine booster option in the ongoing efforts to help fully vaccinate the 50% of U.S. adults who have not received COVID-19 Vaccine booster shots.
NVX-CoV2373 will be available to provide a single dose first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine (Moderna/Pfizer) to individuals 18 years of age and older, for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate. Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted may only be administered this vaccine if they would otherwise not receive a booster dose of a COVID-19 vaccine.
Additional Information can be found here at this link.
Quick access to the EUA links for Healthcare Providers and Recipients can be found under the EUAs COVID-19 Vaccines section of this eDigest on the right side.
NEW! COVID-19 Variant FAQs
How many known variants are there?
There are many. Because viruses constantly change through mutation, new variants occur all the time. Sometimes they disappear, and sometimes they persist. Variants are classified in four ways, from least to most severe: Variants Being Monitored, Variants of Interest, Variants of Concern, and Variants of High Consequence.
Are the newer variants worse than the early COVID-19 strains?
The more recent variants appear to spread much more easily than past known variants, which means they’re more contagious than other variants. We are still learning whether new variants may put infected people at higher or lower risk of hospitalization than past variants.
Do the vaccines protect against new variants?
So far, available data suggest that the vaccines are effective against severe disease and hospitalization caused by variants that are currently circulating. The best protection against any COVID-19 variant is getting fully vaccinated. And a booster dose of vaccine is a proven way to maximize the protection against infection and severe disease.
See data from the COVID-19 Cases and Deaths by Vaccination Status Dashboard for the effects of vaccination on COVID-19 cases and deaths in Texas.
Will a variant make me sicker than previous strains?
The more recent variants appear to spread much more easily than past known variants, which means they’re more contagious than other variants. We are still learning whether new variants may put infected people at higher or lower risk of hospitalization than past variants.
To learn more about variants in the U.S., visit the About Variants of the Virus, Variant Classification, and Variant Surveillance pages on the CDC website.
Reminder: Webinar links
Check out these links from our September 27th COVID-19 Provider Webinar.
COVID-19 Vaccine Product Ordering (VAOS):
Reminder: Webinar Live Q&A Five
Q:If patients don’t want an mRNA vaccine, what can they get instead?
A: If they don't want mRNA, offer Novavax. Vaccine recipients have options!
Q: Can you please add the list of approved WHO authorized/approved vaccines
A: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us-appendix.html#appendix-b
Q:Where can I find past webinars?
A: This link is also found on the right column of your eDigest under Announcements.
https://www.dshs.texas.gov/immunize/covid19/COVID-19-Vaccine-Provider-Webinars/
Q: On the covid cards: If a patient has already gotten 2 boosters and they come in for the bivalent booster. Do we need to give them another card or should we still try and write on the original card?
A: There are 2 additional vaccine spots on the back of the card, if the card is full, you can add an additional card and staple the 2 together! :)
Q: Can you clarify one more time on the Moderna Bivalent dosing?
A: https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf
REMINDER: FDA Authorizes the Bivalent COVID-19 Booster for Younger Age Groups
The FDA now has authorized the bivalent COVID-19 booster vaccines for younger age groups: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines?utm_medium=email&utm_source=govdeliver
- The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
- The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age.
With today’s authorization, the monovalent Pfizer COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.
Regulatory Terminology for COVID-19 Vaccines
Active immunity: The production of antibodies against a specific disease by the immune system. Active immunity can be acquired in two ways, either by contracting the disease or through vaccination. Active immunity is usually permanent, meaning an individual is protected from the disease for the duration of their lives.
Booster shots: Additional doses of a vaccine needed periodically to “boost” the immune system. For example, the tetanus and diphtheria (Td) vaccine which is recommended for adults every ten years.
Vaccine: A suspension of live (usually attenuated) or inactivated microorganisms (e.g. bacteria or viruses) or fractions thereof administered to induce immunity and prevent infectious diseases and their sequelae. Some vaccines contain highly defined antigens (e.g., the polysaccharide of Haemophilus influenzae type b or the surface antigen of hepatitis B); others have antigens that are complex or incompletely defined (e.g. Bordetella pertussis antigens or live attenuated viruses).
For more information, visit Clinical Guidance for COVID-19 Vaccination | CDC.
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