Pfizer submits data to support a booster dose of its COVID-19 vaccine

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Pfizer announced on Monday it had submitted data to the U.S. Food and Drug Administration to support a booster dose of its COVID-19 vaccine.

A third dose of the Pfizer-BioNTech vaccine is not currently authorized for use in the United States except under an August 12 amended Emergency Use Authorization for individuals who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to be immunocompromised at an equivalent.

On Friday, Moderna said the FDA had approved an update to the emergency use authorization for its COVID-19 vaccine to include a third dose to immunocompromised individuals.

The announcements follow a recommendation Friday by Centers for Disease Control and Prevention Director Rochelle P. Walensky for an additional dose of the COVID-19 vaccine for a range of conditions such as recipients of organ or stem cell transplants, people with advanced or untreated HIV infection, active recipients of treatment for cancer, people who are taking some medications that weaken the immune system, and others.

Walensky signed the CDC's Advisory Committee on Immunization Practices' recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.

WHY THIS MATTERS

The CDC said emerging data suggests some people with moderately to severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. 

While people who are immunocompromised make up about 3% of the U.S. adult population, they are more at risk of serious, prolonged illness. 

In addition, in small studies, fully vaccinated immunocompromised people have accounted for a large proportion of hospitalized breakthrough cases (40-44%), the CDC said. Immunocompromised people who are infected are also more likely to transmit the virus to household contacts.

The FDA continues to state that fully vaccinated individuals, other than those who are immunocompromised, do not need an additional vaccine dose right now.

However, as the Delta and other variants drive an increase in the number of COVID-19 cases nationwide, and since research has shown that vaccinated individuals may transmit the virus, the federal government has been fielding questions on the use of a booster shot for protection.

The American Medical Association has announced CPT codes for the third doses of the Pfizer and Modern COVID-19 vaccines.

The CPT Editorial Panel has expedited approval of a new administration code that is unique to a third dose of the current COVID-19 vaccine from Moderna. A new administration code for a third dose of the current COVID-19 vaccine from Pfizer was announced by the AMA on July 30. The two vaccine administration codes are effective for the FDA-approved third doses for certain people with weakened immune systems. 

The CPT codes and long descriptors assigned to third dose administration of the current Pfizer and Moderna COVID-19 vaccines are:

• Pfizer:  0003A - Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; third dose.
• Moderna: 0013A - Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; third dose. 

These CPT codes and descriptors are used to report the actual work of administering the vaccine, in addition to all necessary counseling provided to patients or caregivers and updating the electronic record, the AMA said.

PFIZER

Pfizer and BioNTech have submitted Phase 1 data to the U.S. Food and Drug Administration to support the evaluation of a third, or booster, dose of the companies' COVID-19 vaccine for future licensure. These data will also be submitted to the European Medicines Agency and other regulatory authorities in the coming weeks.

Pfizer said its Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses.

The booster dose elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), and the Beta and Delta variants, compared to the levels observed after the two-dose primary series.

Given the high levels of immune responses observed, a booster dose given within six to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19, Pfizer said.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com