MDA and COVID-19

Experts widely agree that FDA approved or-authorized vaccines are safe and effective and are recommended for all individuals ages 6 months and older.

With over 200 million Americans now vaccinated, real-world evidence further confirms the effectiveness of the vaccines. Data from around the world show substantial decreases in severe illness and death of those who are vaccinated compared to those who are not.

Research is ongoing, but scientists believe the vaccines lose some of their effectiveness against the Omicron variant and subvariants. Some estimates place the effectiveness of a standard 2-dose regimen of an mRNA vaccine at approximately 35 percent effectiveness against infection. However, the standard dosing regimen of available vaccines still do a good job at preventing severe illness, hospitalizations, and death against this variant.

Even better, those with a booster dose are even more protected against Omicron. Some estimates published by the makers of the vaccines estimate a booster dose of the vaccine restores effectiveness against infection to approximately 75 percent. Protection against severe illness is even stronger.

There are many vaccine options available for adults.

• The Pfizer/BioNTech and Moderna vaccines have received full FDA approval for adults and are the primary vaccines recommended.
• The Novavax vaccine has received emergency use authorization for adults. This vaccine uses traditional vaccine technology and is a good option for those who do not want to receive the Pfizer/BioNTech and Moderna vaccines.
• The J&J vaccine has also received emergency use authorization but is only recommended for those who cannot or will not take the Pfizer/BioNTech or Moderna vaccines.

All four vaccines are both safe and effective. We recommend talking to your doctor about which vaccine is the best for you.

The FDA has granted Emergency Use Authorization for both the Pfizer/BioNtech and Moderna vaccines for children ages 6 months and older. To obtain this authorization, both companies had to show its vaccines are both safe and effective for children. The dosing schedule is different depending on the age of the child and which vaccine is chosen. Please consult your doctor to learn which vaccine is right for your child.

For adults who originally received the J&J vaccine, a booster shot is recommended two months after your original dose. For adults who originally received the Pfizer/BioNTech or Moderna vaccines, booster shots are recommended five months after your second dose.

In addition, the CDC authorized a 4^th dose of the Pfizer/BioNTech or Moderna vaccines for adults those who over 50, immunocompromised, or have underlying conditions . Please talk to your doctor about whether a 4^th dose is recommended for you.

For children ages 5-11, a Pfizer/BioNTech booster is recommended at least 5-months after their second dose.

While it is always wise to consult with your doctor before seeking any vaccine (including a COVID-19 booster shot), the waning effectiveness of original vaccine regimens coupled with the strong restoration of protection against severe COVID-19 by a booster shot provide a strong justification for seeking a booster.

Yes, for adults, the FDA has allowed booster shots to be a different brand from a patient’s original vaccine. We recommend consulting with you doctor to decide which brand is the best for you.

Studies are ongoing as to whether the FDA-approved or authorized vaccines are protective in those who are immunocompromised. However, early evidence points to a lessened antibody response in those with weakened immune systems, and consequently potentially a lessened protectiveness against COVID-19. Therefore, health authorities have recommended those who are immunocompromised receive a 3^rd and 4^th dose of the Pfizer or Moderna vaccines. In addition, the CDC also suggests those with compromised immune systems also employ additional protective measures such as avoiding crowds, physical distancing, and mask wearing.

Vaccines are widely available at a variety of facilities, including doctors’ offices, pharmacies, grocery stores, government-run clinics, and more. You can go to https://www.vaccines.gov/ to find a vaccination site near you.

Currently, FDA recommends adults receive the Pfizer/BioNTech, Moderna, or Novavax vaccines. The Agency only recommends the J&J vaccine if the person cannot or will not take the Pfizer/BioNTech or Moderna vaccines.

We recommend talking to your doctor about which vaccine is right for you.

The known sides effects of currently approved or authorized COVID-19 vaccines are generally similar to those of the annual flu vaccine. These include muscle soreness at the injection site, fever, tiredness, body aches, and headache. In very rare cases, reports of myocarditis have been reported in individuals receiving the J&J vaccine. The COVID-19 vaccines do not have a different or more serious set of side effects for NMD patients, and with many individuals with an NMD now having received the vaccine, MDA is not aware of any increased incidence of side effects in individuals with an NMD. You should talk to your doctor about the possibility of more serious side effects of a COVID-19 vaccine for you. But it is widely agreed that potential side effects of the vaccine are substantially dwarfed by the protective benefits they bring, particularly to at-risk communities.

MDA is not aware of any evidence that any of the three FDA approved or authorized COVID-19 vaccinations will have any effect on current or future neuromuscular disease treatments, including gene-based therapies. However, it never hurts to consult with your clinician directly. Upon the FDA authorization or approval of the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines, the FDA did not name any contraindications pertaining to genetic therapies or other medications particularly important to the neuromuscular community. Should there be any contraindications that accompany future Agency decisions, we will update our information accordingly. However, given the many different neuromuscular disorders and courses of treatment, this question can best be addressed by your clinician. For more information on the FDA authorizations, please visit: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.

All individuals regardless of insurance coverage should receive a COVID-19 vaccine free-of-charge. The CARES Act, enacted by Congress in the Spring of 2020, mandated all Medicare beneficiaries and individuals with private insurance obtained through their employer or ACA marketplaces receive the COVID-19 vaccine entirely free of charge. The Families First Coronavirus Response Act, also passed by Congress in 2020, similarly required state Medicaid plans to cover the vaccine free of charge. For those who are uninsured, any provider who is participating in the COVID-19 vaccination program must provide all individuals regardless of insurance status with a free vaccine. Similar free coverage requirements are in place for the VA, Department of Defense, and Federal employees. For more information, please visit: https://www.kff.org/coronavirus-covid-19/issue-brief/vaccine-coverage-pricing-and-reimbursement-in-the-u-s/

No, a prescription will not be necessary to obtain a COVID-19 vaccine, though the process of obtaining a COVID-19 vaccine.. It is the general intention of Federal and state authorities to make a COVID-19 vaccine similarly accessible as other vaccines, such as the flu shot, that generally do not require a prescription.

MDA engaged with the Centers for Disease Control and Prevention as well as state and local public health officials to ensure that decisionmakers were aware of the needs of the NMD community to be able to have the earliest possible access to FDA approved COVID vaccine(s). In October 2020, MDA contacted the CDC asking that individuals with neuromuscular diseases should be included in the early phases of vaccination. In December 2020, MDA joined 19 other neuromuscular disease advocacy groups in contacting every state and jurisdiction asking for phase one access to the vaccine for the neuromuscular community. In February of 2021, MDA joined partnering organizations to urge CDC to provide further guidance to jurisdictions on including individuals with rare diseases during the “high-risk condition” phase.

• Resources provided by American Society of Gene and Cell Therapy (ASGCT) on mRNA vaccines for COVID-19, which includes a short video, FAQ, and an infographic.
• Visit CDC’s Vaccine Information page to learn more about vaccine safety for you and your family.
• CDC is making coronavirus disease 2019 (COVID-19) vaccination recommendations for the United States based on input from the Advisory Committee on Immunization Practices (ACIP). ACIP is a federal advisory committee made up of medical and public health experts who develop recommendations on the use of vaccines in the U.S. public. ACIP holds regular meetings, which are open to the public and provide opportunity for public comment.