Covid-19

There are different treatments available for COVID-19 depending on the severity of illness, patient medical history, etc.

Those treatments include:

• Antiviral Drugs
• Immune Modulators
• SARS-COV-2-targeting Monoclonal Antibodies
• Renal Replacement Therapies

 For additional information on what each type of treatment entails, refer to the COVID-19 Therapeutics section of the FDA’s Coronavirus Drugs website.

There are several different approved and authorized drugs available for treating patients with COVID-19 depending on the severity of illness, age, medical history, etc. For an up-to-date list of approved and authorized drugs, refer to the COVID-19 Therapeutics section of the FDA’s Coronavirus Drugs website.

The CDC has developed Interim Clinical Considerations for COVID-19 Treatment in Outpatients.

They also have developed Clinical Care Considerations for children and Adults with Confirmed COVID-19.

The U.S. Department of Health & Human Services has created a Side-by Side Overview of Outpatient Therapies Authorized for Treatment of Mild-Moderate COVID-19.

The National Institutes of Health (NIH) provides COVID-19 Treatment Guidelines for health care providers.

The FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Pemgarda is authorized for individuals:

• who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2;
  
  

  and

• who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

For more information, please refer to the following resources from the FDA:

Pemgarda Fact Sheet for Health Care Providers

Frequently Asked Questions on the Emergency Use Authorization for Pemgarda

Pemgarda News Release

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to the FDA.

Once submitted, the FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to the FDA based on a final analysis of a Phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.

From a safety perspective, the FDA expects an EUA submission will include all safety data accumulated from Phase 1 and 2 studies conducted with the vaccine, with an expectation that Phase 3 data will include a median follow-up of at least two-months (meaning that at least half of vaccine recipients in Phase 3 clinical trials have at least two months of follow-up) after completion of the full vaccination regimen. In addition, the FDA expects that an EUA request will include a Phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the Phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.

Part of the FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. The FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.

You can find out more about EUAs and COVID-19 vaccines here. 

COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children younger than age 6 months. CDC recommends that people stay up to date with COVID-19 vaccination.

Vaccination schedules for people who are not moderately or severely immunocompromised can be found here. The schedules for individuals who are moderately or severely immunocompromised can be found here. 

Use of mRNA COVID-19 vaccines interchangeably from different manufacturers (Moderna and Pfizer-BioNTech) varies by recipient age, vaccination history, and vaccine product. You can find additional information about the interchangeability of vaccines here.

Side effects after getting a COVID-19 vaccine can vary from person to person. Some people experience a little discomfort and can continue to go about their day. Others have side effects that affect their ability to do daily activities. Side effects generally go away in a few days and tend to be mild, temporary, like those experienced after routine vaccinations. Even if you don’t experience any side effects, your body is building protection against the virus that causes COVID-19.

Children 6 months – 3 Years

Common side effects can include:

• Pain on the leg or arm where the shot was given
• Swollen lymph nodes
• Irritability or crying
• Sleepiness
• Loss of appetite

Children 4 years – 17 Years

Side effects are more common after additional doses, and can include:

• Pain, swelling, and redness on the arm where the shot was given
• Tiredness
• Headache
• Muscle or joint pain
• Chills
• Swollen lymph nodes

Adults 18 year and Older

• Pain, swelling, and redness on the arm where the shot was given. To relieve pain or swelling on the arm where you got the shot:
• Apply a clean, cool, wet washcloth over the area.
• Use or keep moving the arm.
• Get some rest.
• Tiredness, headache, muscle pain, chills, nausea, and fever. To reduce discomfort from fever:
• Drink Plenty of fluids
• Dress in comfortable clothes
• Talk to your doctor about taking over-the-counter (OTC) medicine, such as ibuprofen, acetaminophen, or aspirin.

• It is not recommended to take these medicines before vaccination to try to prevent side effects as it is not known how OTC medicines might affect how well the vaccine works.

  
  

If a patient cannot receive a COVID-19 vaccine due to a contraindication, please see CDC’s Guidance and Recommended Actions here

Some people are immunocompromised (have a weakened immune system) due to a medical condition or from receipt of immunosuppressive medications or treatments. Examples of medical conditions or treatments that may result in moderate to severe immunocompromise can be found here.

The vaccine schedule for people who are moderately or severely immunocompromised can be found here.

Everyone ages 6 months and older vaccinated outside the United States should receive at least 1 dose of an updated (2023–­2024 Formula) mRNA COVID-19 vaccine regardless of past COVID-19 vaccination history (e.g., vaccine type[s], vaccine manufacturer[s], number of doses) unless they received an updated (2023­­–2024 Formula) mRNA COVID-19 vaccine that is FDA-approved or FDA-authorized (i.e., Moderna or Pfizer-BioNTech) or listed for emergency use by the World Health Organization (WHO). COVID-19 vaccines that are listed for emergency use by WHO, but are not approved or authorized by FDA, have not been evaluated for efficacy or safety by CDC or ACIP.

People ages 5 years and older

People ages 5 years and older should receive 1 age-appropriate dose of an updated (2023–­­2024 Formula) mRNA vaccine at least 8 weeks after their last COVID-19 vaccine dose. See vaccine schedule here. (Table 1).

Children ages 6 months–4 years and people who are moderately or severely immunocompromised

For children ages 6 months–4 years, see the vaccine schedule here, and for people who are moderately or severely immunocompromised, see the vaccine schedule here.  People in these two groups may be recommended to receive more than 1 dose of an updated (2023–­­2024 Formula) mRNA vaccine depending on vaccination history.

Special situations

• If unable to determine if a previously received mRNA vaccine dose was an updated (2023­–­2024 Formula) mRNA COVID-19 vaccine, follow guidance for administering an updated (2023­–­2024 Formula) mRNA COVID-19 vaccine dose.
• Novavax COVID-19 Vaccine may be used as a 2-dose primary series and, in limited situations, as a booster dose; for more information see section on Novavax COVID-19 Vaccine.
  

In accordance with general best practices for immunizations, routine administration of all age-appropriate doses of vaccines simultaneously is recommended for children, adolescents, and adults for whom no specific contraindications exist at the time of the healthcare visit. This includes simultaneous administration of COVID-19 vaccine and other vaccines. However, there are additional considerations applicable to all COVID-19 vaccines if administering an orthopoxvirus (mpox) vaccine.

For more information, see Coadministration of COVID-19 vaccines with other vaccines.

CDC Interim Clinical Considerations – Use of COVID-19 Vaccines in the United States

CDC FAQs for the Interim Clinical Considerations for COVID-19 Vaccination

• Vaccine Use and Schedule
• Vaccine Dosage and Formulation
• Age Transitions
• People who are Moderately or Severely Immunocompromised
• Vaccination and SARS-CoV-2 Laboratory Testing
Vaccination and SARS-CoV-2 Infection
Special Populations and Situations

CDC US COVID- 19 Vaccine Product Information

High Risk Conditions: Phase 2: Expanded health conditions as per CDC guidance and additional age category and additional residents of congregate settings

Underlying health conditions who might be at high risk:

• Asthma (moderate‐to‐severe)
• Cerebrovascular disease (affects blood vessels and blood supply to the brain)
• Cystic fibrosis
• Hypertension or high blood pressure
• Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines
• Neurologic conditions, such as dementia
• Liver disease
• Pulmonary fibrosis (having damaged or scarred lung tissues)
• Overweight (BMI of 25 kg/m² and higher, but less than 30 kg/m²)
• Intellectual or neurological disabilities
• Thalassemia
• Type 1 diabetes mellitus age-associated higher risk
• People age 40 - 64 years
• Residents of a congregate setting
• College dormitories
• Military barracks
• Boarding schools
• Summer camps

DOH has regional Public Health Preparedness Coordinators (PHPCs) who will communicate with the counties in their respective regions to organize efforts. DOH will also utilize Regional PEMA offices, Health Care Coalitions, and CMHDs. DOH will utilize a variety of communications platforms to ensure the exchange of information. DOH will also use the Health Alert Network to disseminate information on vaccine eligibility, prioritization, and administration as needed. You can sign up to receive those alerts here.