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Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

As of October 21, 2021, the Federal Drug Administration (FDA)  has amended emergency use approvals (EUAs) for Moderna and Johnson and Johnson vaccines.

Barnstable County will begin providing booster doses of these vaccines as supply allows once we receive approval from CDC and Massachusetts Department of Health.

COVID-19 Booster Shots – Frequently Asked Questions/Concerns

Is a COVID-19 booster shot the same as a third dose of vaccine?

While the actual vaccine and dose is the same, there is a distinction between a third dose and a booster shot. “Third dose” applies to individuals with moderately or severely compromised immune systems who may not have gotten the level of protection they need from the first two doses of vaccine. “Booster shot” applies to the concern that immunity decreases over time.

Both two-dose mRNA vaccines (Pfizer and Moderna) have been approved for a third dose in qualified individuals (people who are moderately to severely immunocompromised)[1].

UPDATE: As of 10/20/21, the FDA is amending emergency use authorizations for Moderna and J & J vaccines to allow for the single use booster dose as follows[2]:

A single booster dose of the Moderna COVID-19 vaccine may be administered at least 6 months after completion of the primary series to individuals:

— 65 years of age and older

— 18 through 64 years of age at high risk of severe COVID-19

— 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

— A single booster dose of the Janssen (Johnson and Johnson) COVID-19 vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

— Each of the available COVID-19 vaccines may be administered as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

PLEASE NOTE: Booster doses of Moderna and J & J vaccine are still pending approval from CDC and MA DPH; once approval has been given, Barnstable County will provide them to qualifying individuals as supply allows.

What is the timeline for third doses of vaccine? What is the timeline for booster shots?

— CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 Vaccine.

— CDC recommends that qualifying individuals who received two doses of Pfizer-BioNTech vaccine at least 6 months ago receive a booster.

— NEW as of 10/20/21: FDA has amended the Moderna and J & J emergency use authorizations regarding approval of booster shots for these vaccines. Massachusetts and subsequently Barnstable County will begin roll-out for these boosters following approval from CDC and MA DPH.

Do booster shot recommendations mean that the vaccine isn’t working?

No. Data shows that the vaccines are working extremely well to keep people from experiencing severe disease or requiring hospitalizations. That said, studies have shown there are certain groups who benefit from an additional dose of vaccine, either because they are immunocompromised and did not respond sufficiently to the standard dosage, because they have waning immunity due to age or because their occupation puts them at risk for increased exposure to the virus.[3]

Studies are currently underway to study to determine whether the general population would benefit from receiving a booster dose. Additional populations may be recommended to receive a booster shot as more data become available.

What exactly are the booster shot recommendations? Am I eligible to receive a booster shot?

The following individuals are currently eligible for a booster dose of Pfizer vaccine 6 months after their second shot*:

— People 65 years and older

— Residents of long-term care settings

— People aged 50–64 years with underlying medical conditions

— People aged 18–49 years with underlying medical conditions

— People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of their occupational or institutional setting (i.e. first responders, education staff, food and agriculture workers, manufacturing workers, corrections workers, U.S. Postal Service workers, public transit workers and grocery store workers).

*The above will also apply to Moderna vaccine recipients following approval from CDC and MA DPH.

New as of 10/20/21: Following approval from CDC and MA DPH, the use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

Can I get a COVID-19 vaccine/booster and flu vaccine at the same time?

Yes, you can get a COVID-19 vaccine and a flu vaccine at the same time.

Even though both vaccines can be given at the same visit, people should follow the recommended schedule for either vaccine: If you haven’t gotten your currently recommended doses of COVID-19 vaccine, get a COVID-19 vaccine as soon as you can, and ideally get a flu vaccine by the end of October.[4]

Is it safe for me to receive a COVID-19 booster?

The FDA and CDC continue to carefully monitor each of the authorized COVID-19 vaccines for safety concerns and will continue to communicate new findings regarding potential safety issues with the public. Serious side effects from the vaccines (such as incidents of blood clots in women of reproductive age who received J & J vaccine and incidents of myocarditis following the second injection of mRNA vaccines) are extremely rare. It’s important to remember that potential safety risks of COVID-19 vaccines must be weighed against serious risk or harm due to the COVID-19 infection.[5]

FROM CDC: “So far, reactions reported after getting the Pfizer-BioNTech booster shot were similar to that of the 2-shot primary series. Fatigue and pain at the injection site were the most commonly reported side effects, and overall, most side effects were mild to moderate. However, as with the 2-shot primary series, serious side effects are rare, but may occur.”[6]

NEW FROM FDA RE: the Moderna Booster – “The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, swollen lymph nodes in same arm as the injection, nausea and vomiting, and fever. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

Ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose. Typically, onset of symptoms has been a few days following vaccination. The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males.

The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose and is administered at least six months after completion of a primary series of the vaccine.

NEW FROM FDA RE: the J & J Booster – “Overall, approximately 9,000 clinical trial participants have received two doses of Janssen COVID-19 Vaccine administered at least two months apart and of these, approximately 2,700 have had at least two months of safety follow-up after the booster dose. Janssen’s safety analyses from these studies have not identified new safety concerns.”

Where can I get a booster shot? Why can’t I go to a County or town-run drive-through booster shot clinic? Why isn’t Cape Cod Healthcare standing up booster shot clinics?

Here on Cape Cod, there is a vast selection of retail pharmacies and healthcare providers that are offering the COVID-19 vaccine. The best way to find a site in your area is through the COVID-19 Vaccine Finder.

Unlike the beginning of vaccine distribution in February of this year, the COVID-19 vaccine is now widely available. There is no longer an essential need to utilize public funding and resources to orchestrate large-scale clinics; resources that that could be dedicated to other important services, such as testing, contact tracing and case investigation. The data that are collected during these efforts helps us understand how the disease spreads in our community, and therefore helps us better guide policy decisions that serve to protect our citizens.

NEW as of 10/20/21: Barnstable County does provide a weekly COVID-19 vaccine clinic that is open to the public every Thursday at the Harborview Conference Room in the Barnstable County Complex from 10am to 2pm. First, second and third doses of Pfizer and Moderna vaccine, as well as Pfizer booster doses for qualified individuals are available at the weekly clinics. Barnstable County does not currently have J & J vaccine in stock. Booster doses of Moderna and J & J vaccine are pending approval from CDC and MA DPH; once approval has been given, Barnstable County will provide them to qualifying individuals as supply allows.

Cape Cod Healthcare (like many hospitals, physician’s offices, and clinics statewide) is already under significant strain due to a burned-out workforce and an excess of patients who have put off care due to COVID and are now in need of urgent medical help. There’s also the issue of emergency department “boarding”; the phenomenon of patients waiting more than 12 hours for behavioral health services and admittance to inpatient psychiatric units (“one important dynamic likely impacting the increase in behavior health ED boarding is the loss of nearly 270 psychiatric beds in the Commonwealth due to closures and COVID-10 related physical distancing and quarantine protocols”). [7]

Side note: People in need of healthcare services (emergency or otherwise) are urged to exercise patience with our healthcare workers and remember that they deserve kindness and consideration during what continues to be a very challenging time. It’s important to remember that these essential workers continue to show up for their patients day after day in spite of significant personal and professional stress.

What is the timeframe/outlook for the pediatric COVID-19 vaccine?

The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.[8]

[1] COVID-19 Vaccines for Moderately to Severely Immunocompromised People | CDC

[2] Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines | FDA

[3] Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC

[4] Frequently Asked Influenza (Flu) Questions: 2021-2022 Season | CDC

[5] Is the COVID-19 Vaccine Safe? | Johns Hopkins Medicine

[6] Who Is Eligible for a COVID-19 Vaccine Booster Shot? | CDC

[7] Impact of COVID-19 on the Massachusetts Health Care System: Interim Report PowerPoint Presentation (

[8] FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children | FDA