VAERS

Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance

Retrieved on: 
Friday, October 13, 2023

Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Key Points: 
  • Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
  • Please include “Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula) EUA” in the first line of box #18 of the report form.
  • In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

Retrieved on: 
Monday, September 11, 2023

Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

Key Points: 
  • Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
  • Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
  • The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.
  • Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Pregnancy Outcomes with COVID-19 Vaccines Reviewed in Journal of American Physicians and Surgeons (AAPS)

Retrieved on: 
Tuesday, March 21, 2023

Their summary is published in the spring issue of the peer-reviewed Journal of American Physicians and Surgeons.

Key Points: 
  • Their summary is published in the spring issue of the peer-reviewed Journal of American Physicians and Surgeons.
  • Influenza vaccines were chosen as the control group because the CDC first approved influenza vaccines for pregnant women in 1997.
  • The study period provides 282 months of data for the influenza vaccine and 18 months of data for the COVID-19 vaccines.
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

‘Negative Evidence’ on COVID-19 Vaccines and Cancer Reviewed in the Journal of American Physicians and Surgeons (AAPS)

Retrieved on: 
Tuesday, March 21, 2023

Government agencies have assiduously sought to detect even the slightest carcinogenic properties of any product to which humans are frequently exposed, states Dr. Orient.

Key Points: 
  • Government agencies have assiduously sought to detect even the slightest carcinogenic properties of any product to which humans are frequently exposed, states Dr. Orient.
  • A dedicated registry is essential, she explains, because conventional surveillance systems, like the Vaccine Adverse Event Reporting System (VAERS) are not designed to pick up delayed effects.
  • The article explores various theoretical mechanisms for inducing cancer.
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.