Knowledge Base Article

This week we highlight key updates spanning from February 23rd through March 2nd, 2020.

Resource Spotlight: VaccineFinder

According to the CDC, “VaccineFinder is a free, online service where users can search for pharmacies and providers that offer vaccination. Information about where COVID-19 vaccines are available is provided directly by pharmacies and providers, in collaboration with states, and is updated daily. VaccineFinder is operated by Boston Children’s Hospital, in partnership with CDC.”

At this time VaccineFinder is launching in four states and will expand information for additional states in the coming weeks. If information is not yet available where you live, the CDC has advised that you visit your state health department’s website. Links to State and Territorial Health Department websites are available on the CDC website.  

February 24, 2021: FDA’s New Webpage: COVID-19 Vaccination & the Food and Agriculture Sector

The FDA launched this new webpage to provide information for the food and agriculture sector about the following:

• Safety and effectiveness of COVID-19 vaccines authorized for emergency use by the FDA,
• Benefits of COVID-19 vaccination, and
• Information about the availability of vaccines in your community.

February 25, 2021: FDA Flexibilities for Storing Pfizer-BioNTech COVID-19 Vaccine

In an FDA Bulletin, the FDA announced their decision to allow “undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.” This announcement includes an updated Fact Sheet for Health Providers Administering Vaccine.

February 26, 2021: FDA Vaccine Advisory Committee working towards Emergency Use Authorization for Janssen Biotech Inc. COVID-19 Vaccine

Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research announced in an FDA bulletin that “Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.”

February 27, 2020: Janssen COVID-19 Vaccine Granted Emergency Use Authorization

A little over twenty four hours after the FDA’s Vaccine Advisory Committee met they published a bulletin announcing emergency use authorization for the Janssen COVID-19 vaccine for individuals 18 years of age and older. “The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”

February 27, 2020: Johnson & Johnson COVID-19 Vaccine Press Release

Johnson & Johnson announced the EUA for their vaccine indicating that the “vaccine was 85 percent effective in preventing severe disease across all regions studies, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.” Unique to this COVID-19 vaccine, it is a single shot vaccine. Side effects that have been reported with the vaccine include:

• Injection site reactions: pain, redness of the skin, and swelling
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.

Johnson & Johnson indicates that the company has already started shipping the vaccine and “expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.”

March 1, 2021: CMS COVID-19 Vaccines and Monoclonal Antibodies Webpage

CMS continues to add to this webpage as additional COVID-19 vaccines and certain monoclonal antibodies receive Emergency Use Authorization. On this page you will find tables for COVID-19 vaccines and monoclonal antibodies detailing the code, CPT descriptor, the vaccine/procedure name, payment allowance and effective dates. There is also a wealth of information available in the Additional Resources section. Most recently added is a Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction download.  This webpage was last modified on March 1, 2021 to include information about the new Janssen COVID-19 vaccine by Johnson & Johnson. I encourage you to check this webpage often for updates.

March 1, 2021: Quidel QuickVue At-Home COVID-19 Test

The FDA issued a EUA for the Quidel QuickVue At-Home COVID-19 Test. Specifically, The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.”

March 2, 2021: CDC Call – What Clinicians Need to Know about Johnson & Johnson’s Janssen COVID-19 Vaccine

The CDC hosted a Clinical Outreach and Communication Activity (COCA) call on March 2nd to provide clinicians an overview of the J&J Janssen COVID-19 vaccine including vaccine characteristics and administration, vaccinating special populations, and contraindications. You can access call materials from this presentation on the CDC website.