COVID-19 Vaccination & Approved Treatments –
What You Need To Know
We all have spent the last year doing our best to keep ourselves and our families safe, while adjusting to this new virtual world. PPMD recognizes this has been nothing short of challenging, and we remain committed to providing support, community engagement, and the most accurate and up-to-date information possible during a time of unknowns. This extends to new learnings of COVID-19 vaccines, which PPMD believes to be the best form of protection against the virus, and approved COVID-19 treatments for those at risk. We hope these options are potential solutions to alleviate this pandemic.
Please continue to submit questions to ellen@parentprojectmd.org, so we can continue to adapt our resources to your concerns.
Approved Drugs for At-Home COVID-19 Treatment
| PAXLOVID™ (PF-07321332; ritonavir) | MOLNUPIRAVIR (MK-4482/EID-2801) | |
|---|---|---|
| Sponsoring Company | Pfizer | Merck and Ridgeback Therapeutics |
| Medication Type | Oral antiviral | Oral antiviral |
| Mechanism of Action | Combination of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations | Blocks the ability of the SARS-CoV-2 virus to replicate |
| Eligibility | Adults and children ages 12+ (weighing at least 40 kg) with moderate Covid who are at risk for severe disease, including hospitalization or death | Adults (18+) with mild-moderate Covid who are at risk for severe disease, including hospitalization or death |
| Dosing and Frequency | Packaged as 300 mg nirmatrelvir (2 x 150 mg tablets) with 100 mg ritonavir. All 3 tablets should be taken together orally twice daily for 5 days. | 800 mg (4 x 200 mg capsules) taken orally twice daily for 5 days. Treatment should be started within 5 days of symptom onset. |
| Drug Interactions | Alfuzosin; Pethidine, piroxicam, propoxyphene; Ranolazine; Amiodarone, dronedarone, flecainide, propafenone, quinidine; Colchicine; Lurasidone, pimozide, clozapine; Dihydroergotamine, ergotamine, methylergonovine; Lovastatin, simvastatin; Sildenafil (Revatio®) for pulmonary arterial hypertension (PAH); Triazolam, oral midazolam; Apalutamide; Carbamazepine, phenobarbital, phenytoin; Rifampin; St. John’s Wort (hypericum perforatum) | No drug-drug interactions identified |
| Efficacy | Interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint) | Reduced the risk of hospitalization or death by approximately 50% |
| Access | Prescribed by provider | Prescribed by provider |
| Possible Side Effects | Altered sense of taste; diarrhea; high blood pressure; muscle aches; tell your healthcare providers right away if you have any signs or symptoms of liver problems including loss of appetite, yellowing of skin or eye, dark-colored urine, pale colored stools, itchy skin, or abdominal pain. | Diarrhea; dizziness; headache; hives, itching, skin rash; nausea; redness of the skin; vomiting; no serious side effects reported in clinical trials |
| Approval | U.S. FDA for Emergency Use Authorization (EUA) See FDA fact sheet for patients, parents, and caregivers | U.S. FDA for Emergency Use Authorization (EUA) See FDA fact sheet for patients and caregivers |
* Table reflects COVID-19 treatments that have received emergency use authorization from the US Food and Drug Administration (FDA) as of December 23, 2021.
OVER-THE-COUNTER MEDICATIONS FOR SYMPTOM MANAGEMENT
Often mild COVID-19 cases can be treated at home with adequate hydration, rest, and symptom management with over-the-counter medications. If you or your child tests positive for COVID-19, we recommend alerting your doctor and discussing treatment plans, including safe and appropriate medications to take. PPMD also developed a resource of safe and unsafe medications for children and adult with Duchenne that may be helpful.
Download PPMD’s Safe & Unsafe Medications ResourceVaccines Currently Available for COVID-19
| Pfizer | Moderna | Janssen Biotech/Johnson and Johnson | |
|---|---|---|---|
| Vaccine Platform | mRNA encased in lipid nanoparticles (fat bubbles) to keep it from degrading | mRNA encased in lipid nanoparticles (fat bubbles) to keep it from degrading | Recombinant, replication-incompetent human adenovirus type 26 vector |
| Age of Inclusion | 5 years + | 18 years + | 18 years + |
| Accessibility | Storage between -94 degrees Fahrenheit (institutional research freezers), stable x5 days after thaw | -4 degrees Fahrenheit (regular freezer), stable x30 days after thaw and at room temperature for 12 hours | 36 degrees Fahrenheit to 46 degrees Fahrenheit (regular refrigerator); or 47 degrees Fahrenheit to 77 degrees Fahrenheit (room temperature) for up to 12 hours |
| Dosing Schedule | 2 injections given 21 days apart; 30µg dose given for 12+ and 10µg given for 5-11yrs | 2 injections given 28 days apart | Single dose |
| Efficacy | 95% effective | 95% effective | 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination, 100% effective in preventing death |
| Possible Side Effects | Pain at injection site, fatigue, mild fever, headache, muscle pain, joint pain, fever; younger adults have reported more side effects than older adults. *In 5-11 year olds, more redness and swelling at injection site, and less frequent/milder fever. | Pain at injection site, fatigue, mild fever, headache, muscle pain, joint pain, fever; younger adults have reported more side effects than older adults | Pain at the injection site, headache, fatigue, muscle aches and nausea |
| Additional Doses | Yes, if moderately or severely immunocompromised. Administer at least 28 days after the second dose. Ages 5+. | Yes, if moderately or severely immunocompromised. Administer at least 28 days after the second dose. Ages 18+ | Unknown |
| Booster Doses | Yes, for people 12 years and older, five months after completion of primary series. **Booster shots may be mixed and matched. You can receive the same type you originally received, or receive a different type. CDC recommendations now allow for a mix/match approach to booster administration. | Yes, for people 18 years or older, six months after completion of second (or third) dose, at one-half the original dose. **Booster shots may be mixed and matched. You can receive the same type you originally received, or receive a different type. CDC recommendations now allow for a mix/match approach to booster administration. | Yes, for all people 18+, at least two months after first dose. **Booster shots may be mixed and matched. You can receive the same type you originally received, or receive a different type. CDC recommendations now allow for a mix/match approach to booster administration. |
| Approval | Full FDA approval for 18+; Emergency Use Authorization for 5-11 and 12-17 | Emergency Use Authorization | Emergency Use Authorization |
* Table reflects CDC guidelines as of January 4, 2022.
HOW THE MRNA-BASED COVID-19 VACCINES WORK
The new mRNA-based COVID-19 vaccines currently authorized in the US are a little different from conventional vaccines. The vaccines developed by Pfizer and Moderna both include genetic material consisting of messenger RNA (mRNA) particles that encode for the spike protein from the COVID-19 vaccine encased in a lipid nanoparticle (tiny fat bubble) that allows the mRNA to remain intact and keep the fragile mRNA from being degraded.
Injecting the mRNA instructs your body’s cells to make a piece of the spike protein from the virus. Each time the body’s cells replicate this tiny piece of the spike protein, it is alerted that there is now a foreign protein in the body and is prompted to create antigens to the protein.
By developing its own antibodies to the COVID-19 spike protein, the body mounts an immune response to that protein, protecting the body against the invader.
Learn more >How the new adenovirus-based vaccine for COVID-19 is different
The FDA approved, under emergency use authorization, Janssen Pharmaceuticals – Johnson and Johnson’s new COVID-19 vaccine. The Janssen vaccine is the first adenovirus-based COVID-19 vaccine to be approved for use, which is different than the Pfizer and Moderna vaccines, which are mRNA-based.
Janssen’s COVID-19 vaccine uses a type of adenovirus, specifically adenovirus type 26 (Ad26), to deliver a piece of the DNA that is used to make the distinctive “spike” protein seen in SARS-CoV-2. Adenoviruses are relatively common and can cause a variety of mild illnesses in humans. However, Ad26, which typically causes the common cold and pink eye, is modified so that it cannot replicate nor cause illness, and instead transports the necessary genetic material into the body, prompting it to create the spike protein and generate an immune response against COVID-19.
It is important to differentiate between adenovirus, which is the vector used in the Janssen vaccine, and adeno-associated virus, which is used to delivery gene therapies in clinical trials for the treatment of Duchenne and other genetic conditions. While their names are similar, their molecular patterns (antigens) are distinct, so immunity to one type does not give immunity to another type.
Because of this key difference, the Janssen vaccine is safe for people with Duchenne to receive, including those who have received or hope to receive gene therapy.
However, if a vaccine were approved using an adeno-associated virus platform, it would be important for people wishing to receive gene therapy to avoid it.
People Eligible for Booster Doses:
If you received Pfizer-BioNTech or Moderna COVID-19 Vaccination, the following groups are eligible for booster doses:
- Older adults age 65 years and older
- Long-term care setting residents ages 18 years and older
- People with underlying medical conditions ages 60-64 years should get a booster
- People with underlying medical conditions ages 18-49 years may get a booster
- People who work or live in high-risk settings ages 18-64 years
Additional Doses vs. Booster Doses:
Additional doses are not to be confused with booster doses. Additional doses, given shortly after the two-dose series of Pfizer or Moderna, are for people who may not mount a sufficient response to the initial vaccination. Additional doses are administered 28 days after the second dose. This is different from booster doses, which are given several months after vaccination when vaccine protection may begin to decrease.
While booster doses for Pfizer are recommended for people 12+, additional doses are available to moderately or severely immunocompromised individuals ages 5 and older.
Webinar Recording: PEDIATRIC COVID-19 VACCINATION (AGES 5-11) & DUCHENNE
On November 5, 2021, PPMD invited Drs. Tim Cripe and Tim Franson back for another COVID-19 vaccine webinar to provide updates on the new pediatric approval and what it means for the Duchenne community. Our panelists shared important information on vaccine development, impact of COVID-19 on children, vaccine safety in the 5-11 age group, and additional context about third vs. booster doses in immunocompromised individuals.
Webinar Recording: COVID-19 VACCINATION & DUCHENNE – WHAT YOU NEED TO KNOW
On December 11, 2020, PPMD invited Dr. Tim Cripe, who brings expertise on vaccine development and clinical trials, and Dr. Tim Franson, who offers insight into the FDA and regulatory pathways, to guide us through currently available data on vaccine mechanisms of action, development, and regulatory pathways for approval and distribution by joining us for a webinar to discuss what we know.
