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COVID-19 Vaccine News

Pfizer-BioNTech COVID-19 Vaccine Receives Full FDA Approval

On August 23, 2021, the FDA gave full approval to the Pfizer COVID-19 vaccine for individuals 16 years and older. This authorization required extensive testing and proof of efficacy and safety of the vaccine. This designation puts Pfizer’s coronavirus vaccine in the same category as other widely used vaccines, such as those that prevent chicken pox, measles, and polio. Pfizer also announced it would be calling the vaccine by the brand name Cominarty. The Pfizer vaccine continues to be available to adolescents ages 12 to 15 under an Emergency Use Authorization (EUA). Full FDA approval for that age range is expected in the future.

Full approval for the Moderna and Johnson & Johnson COVID-19 vaccines is expected in the coming weeks and months. Those manufacturers started the full FDA approval authorization process after Pfizer.

CDC Recommends 3rd Dose of mRNA Vaccine for Certain Immunocompromised People

On Thursday, August 12, 2021, the CDC recommended certain people who are moderately to severely immunocompromised should receive an additional dose of mRNA COVID-19 vaccine after the initial 2 doses. This recommendation was made specifically for an additional dose of Pfizer vaccine for individuals 12 years and older or Moderna COVID-19 vaccine for individuals 18 years and older after they complete their initial 2-dose primary vaccine series. At this time, the Janssen (Johnson & Johnson) vaccine has not yet been authorized by the FDA and CDC for an additional COVID-19 vaccine dose.

Over the past week, we have started contacting our patients whose medical records indicate they meet the immunocompromised criteria to invite them to schedule a third dose of Moderna or Pfizer vaccine. Response has been very high and unfortunately at this time we do not have any remaining third dose appointments available at Atrius Health. As we continue our outreach to these patients, we will be strongly encouraging them to use vaxfinder.mass.gov to find locations near them to get vaccinated as soon as possible. Both CVS and Walgreens are offering third dose appointments across the state.

CDC Recommends COVID-19 Vaccination for People Pregnant or Breastfeeding

On August 11, 2021, the CDC released the latest data on the safety of the COVID-19 vaccines in pregnant people. They are recommending all people 12 years of age and older get vaccinated against COVID-19, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. The American College of Obstetrics and Gynecology and the Society of Maternal Fetal Monitoring have also announced that vaccination is safe and effective for pregnant women and protects the baby after it is born. In recent weeks, the number of pregnant people infected and hospitalized with COVID-19 has been rising. The increased risk of severe illness and pregnancy complications related to COVID-19 infection among pregnant people make vaccination for this population more urgent than ever.

Vaccine Booster Shots for General Population

You may have read that COVID-19 booster shots for the general population may become available beginning in late September 2021. Booster shots for the general population have not yet been approved and are subject to authorization by the U.S. Food and Drug Administration and recommendation by CDC’s Advisory Committee on Immunization Practices (ACIP). As a result, we are not currently offering booster doses to the general population. We do offer the COVID-19 vaccine additional dose to patients who are moderately or severely immunocompromised in accordance with the ACIP recommendations that were published in August. We will closely monitor any announcements regarding booster shots for the rest of the population from the FDA, CDC and Massachusetts Department of Public Health and share information with patients as it becomes available.

Atrius Health Employee Vaccine Mandate

Atrius Health recently announced that all employees must be vaccinated against COVID-19 by October 29, 2021, except for those who receive a religious or medical exemption. We believe vaccines are critical for decreasing the spread of the virus as well as preventing serious illness, hospitalizations and deaths. Protecting our patients, our staff and the health of our community is a core part of the Atrius Health mission and an obligation we take very seriously as a healthcare organization.