Early January: we are awaiting ‘greenlight’ approval by Sponsor (Novavax) as of this writing (20/December/2021)

Anyone who received BOTH Novavax doses (either in initial vaccination or during crossover)Anyone who was unblinded and received NO doses of Novavax but received 2 doses of any FDA EUA or BLA CoVID-19 Vaccine.

• If it has been at least 6 months since last vaccine against CoVID-19
• If you need clarification or have questions, please call study team

If you have recently had COVID-19 and are 18+, it's recommended that you wait to get a booster until four weeks after infection and the recommended time has elapsed since your primary series of either Pfizer or Moderna (6 months) or J&J (2 months).

Depending on your specific history as it relates to (1) when you received your Novavax primary vaccinations, (2) if and when you received FDA EUA or BLA CoVID-19 vaccinations outside of the Novavax vaccine trial, and (3) if and when you might have had a CoVID-19 infection, our VTU clinical providers recommend that you consider:

a. Scheduling a call with your primary care provider to discuss this OR with one of our VTU Clinical Providers.

b. Possibly obtaining a blood Antibody test to check for seropositivity to the Spike Protein. (The test can assist in your decision to get an FDA approved or EUA booster. Your Primary Care Physician can order SARS-CoV-2 Antibody, IgG, Spike 164055.

COVID-19 Serology (Antibody) Test

If it has been 6 months or more since your last CoVID-19 vaccination, we recommend you consider receiving a ‘booster’ vaccination according to the guidelines provided by CDC.

COVID-19 Vaccine Booster Shots

If you are a study participant in the Novavax Phase 3 Vaccine Trial, and it has been 6 months or more since you received your 2nd dose of Novavax vaccine product, then it is recommended you receive the BLA approved vaccine Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC or wait for Novavax booster through the vaccine trial.

  • Because it is possible to get reinfected after natural CoVID-19 infection, vaccination against CoVID-19 is recommended.

  • While current data is not available as it relates to ‘breakthrough’ infection post Novavax primary series of vaccinations, Novavax is planning to provide booster doses with Novavax vaccine product (same dose).

  • Currently, limited information on the durability of natural immunity post CoVID-19 infection. Research has not yet shown how long you are protected from getting CoVID-19 again after you recover from CoVID-19 infection, and the timing to receive a ‘booster’ dose. We recommend that you consider:

   a. Scheduling a call with your primary care provider to discuss this OR with one of our VTU Clinical Providers.

  b. Possibly obtaining a blood Antibody test to check for seropositivity to the Spike Protein. (The test can assist in your decision to get an FDA approved or EUA booster. Your Primary Care Physician can order SARS-CoV-2 Antibody, IgG, Spike 164055

COVID-19 Serology (Antibody) Test

COVID-19 Vaccine Booster Shots

There are currently ongoing studies that are demonstrating a very good immune response with a Novavax booster following another EUA approved vaccine (Moderna, Pfizer, J&J). Staying in the study will help us improve our understanding of how the Novavax vaccine works with the booster. We have not seen any data to make us think that Novavax is inferior to the other EUA or FDA approved vaccines.

Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

Sometimes study specific information is only disseminated to the Novavax sites through our study calls or investigator specific communication. Because it is not done as a general press release, it may not be picked up by trusted news organizations that you regularly visit for information.

We are still calling you for safety follow ups every 3 months. As soon as the Novavax booster is ready and approved by Novavax, we will contact you to setup that visit.

Your in-person visits are at- 12-months; 18-months and 24-months (and possibly a BOOSTER visit). We also do monthly follow up phone calls (starting at month 13)

For you, everything will be over the phone. Safety Follow Up Phone calls are every 3 months. However, Novavax announced in a phone call with study sites on November 19, 2021, that so long as you have received 2 doses of the Novavax vaccine product, you may be eligible to receive the ‘booster’ dose, which would be an ‘in -person’ visit.

For you, everything will be over the phone. Safety Follow Up Phone calls are every 3 months. However, Novavax announced in a phone call with study sites on November 19, 2021, that so long as you have received 2 doses of the Novavax vaccine product, you may be eligible to receive the ‘booster’ dose, which would be an ‘in -person’ visit.

You must do eDiaries for the first 12 months (and possibly for 7 days post Booster)

EUA/Unblinded should no longer complete eDiaries.

Many participants have travelled internationally with Novavax Vaccine Card. It is best to check the requirement of individual country and airline. Here are CDC website links that show Novavax as an approved Vaccine for travel.

Click here

Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants

This is on case-to-case basis. Our providers can do your company exemption request for you after talking to you. If it is not accepted, you can get Pfizer vaccine from pharmacy of your choice.