Section 5: Vaccines, Treatments, and Testing



Vaccines, Treatments, and Testing

treatments

Treatments

To stay updated on the latest treatments, please visit Combat Covid, a one-stop resource created by the US Department of Health and Human Services (HHS) to help win the fight against COVID-19. Combat COVID has the latest on COVID-19 news, vaccines, treatments, and research.

Monoclonal Antibodies

In November 2020, the FDA issued an Emergency Use Authorization (EUA) for casirivimab and imdevimab to be administered together to treat mild to moderate COVID-19 in adults and children (12 years of age or older weighing at least 88 lbs) who test positive for COVID-19 and who are at high risk for progressing to severe COVID-19. This EUA includes those 65 years of age or older or who have certain chronic medical conditions.

In February 2021, the FDA issued an EUA for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In December 2021, this indication was expanded to all younger pediatric patients, including newborns. This approval is for the treatment of mild to moderate COVID-19 in those who are at high risk for progression to severe COVID-19 or for those who have a positive COVID-19 test and are at high risk. The combination is also given for post-exposure prophylaxis for prevention of COVID-19 in those at high risk of progression to severe COVID-19.

In May 2021, the FDA issued an EUA for the monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and kids aged 12 years and older.

In June 2021, the FDA issued an EUA for intravenous Actemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen or breathing support. Four randomized, controlled studies with more than 5,500 hospitalized patients suggest that Actemra may improve outcomes in these types of patients.

In December 2021, the FDA issued an emergency use authorization (EUA) for Evusheld™ (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older). The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have a moderate to severely compromised immune system or a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines.

Convalescent Plasma

This treatment has been used in trials and in clinical settings to help some COVID-19 patients. In February 2021, the FDA revised the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to plasma with high “titer” (concentration of COVID-19 antibody). Evidence suggests plasma with low levels of antibodies is not effective in treating COVID-19. The therapy was originally granted Emergency Use Authorization by the FDA in August 2020.

Antiviral drugs

In May 2020, the FDA granted an Emergency Use Authorization (EUA) for medical professionals to treat coronavirus with the antiviral medication, remdesivir. Known by the brand name Veklury®, remdesivir is given daily via intravenous infusion for up to 10 days.

In December 2021, the FDA issued an emergency use authorization (EUA) for two oral antiviral medications for the treatment of COVID-19 in certain patients. These are the first medications in pill or capsule form that are taken by mouth for the treatment of mild-to-moderate COVID-19 and may be given to outpatients. 

Neither medication is authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Both treatments are available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Neither medication is a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The safety and effectiveness of these oral therapies for the treatment of COVID-19 continue to be evaluated.

The first treatment given this authorization was Pfizer’s Paxlovid™ (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use). It is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 pounds or more) who test positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is given in three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Possible side effects include impaired sense of taste, diarrhea, high blood pressure, and muscle aches. Using Paxlovid at the same time as certain other drugs (or soon after discontinuing those drugs) may result in potentially significant drug interactions.

Merck’s molnupiravir was the second oral medication to be authorized for the treatment of mild-to-moderate COVID-19 in adults (but not pediatric patients) testing positive for SARS-CoV-2, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth.

Molnupiravir is given in four capsules taken by mouth every 12 hours for five days, for a total of 40 capsules. This medication is not authorized for use for longer than five consecutive days. In the clinical trial, side effects included diarrhea, nausea, and dizziness. Animal reproduction studies show that molnupiravir may cause fetal harm when administered to pregnant individuals, so this medication is may only be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir would outweigh the risks for that individual patient.

Over the Counter (OTC) Symptom Management

Health officials recommend over-the-counter medicine such as acetaminophen (Tylenol®) to treat fever. As always, consult your healthcare provider if you feel sick.

Drugs No Longer Considered Effective

Also in June 2020, the FDA revoked emergency authorization of hydroxychloroquine and chloroquine as benefits have not been shown to outweigh the risks. However, some reports still present different findings.
*Do not take non-pharmaceutical chloroquine phosphate or ingest or inject any disinfectants. Do not take medication to treat coronavirus that has not been prescribed by your healthcare provider for this explicit purpose.

The CDC lists FAQs about treatments and therapies.

Treatment Overview

According to Combat Covid, treatment options for individuals with COVID-19 are as follows:

If at home, monoclonal antibodies may be given to attack the virus. This therapy is appropriate if the individual has mild to moderate symptoms, or if the individual has no symptoms but has been exposed to the virus and is at risk for serious illness. These monoclonal antibodies include:

If at home, without serious symptoms, two oral antiviral medications have also been authorized for the treatment of COVID-19 in certain patients only.

  • Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) – for adults and children (age 12 and older) at high risk for progression to severe COVID-19
  • molnupiravir – for adults (age 18 and older) at high risk for progression to severe COVID-19 who have no other appropriate or accessible treatment options

If at the hospital, in addition to some of the therapies listed above, other treatment options include:

  • Actemra® (tocilizumab), a fourth monoclonal antibody option for adult and pediatric patients (2 years of age or older) in the hospital
  • Convalescent plasma, to provide more antibodies to help fight the virus and reduce inflammation, although more studies are needed to confirm its efficacy
  • Veklury® (remdesivir), an antiviral medication that blocks the virus from replicating in the body
  • Baricitinib, a rheumatoid arthritis medication that reduces inflammation through an immune response, to be given in combination with remdesivir
  • Corticosteroids, which may also be used to help reduce inflammation through an immune response

vaccines

Vaccines

MSAA, along with all of the MS organizations within the MS Coalition have signed on to the following COVID-19 vaccine guidance for people with MS.

Given the serious nature and risks associated with COVID-19, MSAA supports the MS community getting the COVID-19 vaccine in coordination with one’s healthcare provider.

The CDC has created a tool so that you can get the latest COVID-19 vaccine information to help you find the closest location to receive a vaccine. You may also call (800) 232-0233 or simply text your zip code to 438829 for a list of nearby vaccination sites.

The CDC also offers helpful vaccine guidance including: how to prepare for your vaccination, what to expect at your appointment and immediately after, and things such as how to schedule your second dose, or what to do if you’ve lost your vaccine card.

Follow CDC guidelines about what you can and cannot safely do once you are fully vaccinated.

Vaccine Background

In December 2020, the Pfizer and Moderna vaccines were granted Emergency Use Authorization (EUA). In February 2021, the Johnson & Johnson (J&J) was the third vaccine granted EUA. In April 2021, the FDA and CDC recommended pausing the use of the J&J vaccine out of an abundance of caution due to a concern it may cause a rare but severe blood clots disorder. Later that same month, The FDA and CDC lifted the recommended pause on J&J after a thorough safety review.

In February 2021, a study demonstrated a 94% decrease in COVID-19 symptomatic infection in a population of 596,618 Pfizer-vaccinated individuals compared with 596,618 unvaccinated. The study was conducted between December 20th, 2020 to February 1, 2021 in collaboration between Harvard University and Clalit Research Institute in Israel.

In May 2021, Pfizer announced it has started clinical trials of a COVID-19 booster coupled with a pneumonia vaccine. These studies are being conducted with fully vaccinated adults over 65, using Pfizer’s pneumonia vaccine along with a third dose of its COVID-19 shot. The purpose of these trials is to test the safety as well as the degree of immune response in those receiving both vaccines at the same time.

In May 2021, the CDC published findings that indicate the approved vaccines are extremely effective at preventing “breakthrough” infections from COVID-19 and variants. A very low number of cases have been reported through a voluntary reporting system, and in the rare instances of infection-breakthrough in fully vaccinated individuals, the majority of cases are asymptomatic or mild and do not require hospitalization.

Given the fact that although rare, breakthrough infections can still occur in individuals who have been vaccinated, the CDC has also published Interim Public Health Recommendations for Fully Vaccinated People. At the time of this writing, the CDC reports that mRNA vaccines (Pfizer-BioNTech and Moderna) provide protection against variants of concern, including the B.1.1.7 strain. A growing body of evidence also suggests that those who are fully vaccinated with an mRNA vaccine are less likely to transmit COVID-19 to others. Studies are currently underway to learn more about efficacy and transmission rates for the Johnson & Johnson vaccine.

In January 2022, the FDA revised the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include: a single booster dose for use in individuals 12 through 15 years of age; reduce the wait time for a booster dose to five months rather than six; and allow a third primary series dose for certain immunocompromised children 5 through 11 years of age. Also in January, the FDA revised the EUA for the Moderna COVID-19 Vaccine to shorten the wait time for a booster dose to at least five months for individuals 18 years of age and older. 

Vaccine Schedule Overview

(As of January 2022)

Pfizer-BioNTech

  • Recommended for age 5 and up
  • Primary Series: 2 doses given 3 weeks (21 days) apart 
  • When Fully Vaccinated: 2 weeks after 2nd dose
  • Booster Dose: Everyone ages 12 years and older is eligible at least 5 months after the last dose in their primary series. Any of the three COVID-19 vaccines can be used for the booster dose in those 18 and older; only the Pfizer vaccine may be given as a booster in those ages 12 to 17.
  • A third primary series dose is allowed for certain immunocompromised children ages 5 and older.

Moderna

  • Recommended for age 18 and up
  • Primary Series: 2 doses given 4 weeks (28 days) apart
  • When Fully Vaccinated: 2 weeks after 2nd dose
  • Booster Dose: Everyone ages 18 years and older is eligible at least 5 months after the last dose in their primary series. Any of the three COVID-19 vaccines can be used for the booster dose.

Johnson & Johnson’s Janssen

  • Recommended for age 18 and up
  • Primary Series: 1 dose
  • When Fully Vaccinated: 2 weeks after 1st dose
  • Booster Dose: At least 2 months after the first dose for all people ages 18 years and older. Any of the three COVID-19 vaccines can be used for the booster dose.

Additional Vaccine Details

In a large-scale study of pregnant people who received an mRNA vaccine, outcomes for both mother and baby appear similar to pre-COVID-19 outcomes.

Wired magazine provides details on vaccine hesitancy and how the COVID-19 vaccines were evaluated.

The CDC is advising those who are pregnant or breastfeeding to consult with their healthcare provider about getting vaccinated for COVID-19. Pregnant women testing positive for COVID-19 are at increased risk for adverse outcomes, compared to pregnant women who do not have COVID-19.

Some COVID-19 long-haulers are reporting relief from their symptoms after being vaccinated.

In the past, with typical flu vaccines, the injectable, “inactive” type of flu vaccine is considered safe for individuals with MS, while the “live-virus” vaccine given via nasal spray is not recommended. Additionally, individuals who recently experienced an MS relapse should consult their physician before receiving a flu vaccine.

NPR reported that receiving a live, attenuated flu vaccine (via nasal spray) may possibly offer some protection against COVID-19, even though the current flu vaccine was not created for COVID-19. According to a top virologist, “live” flu vaccines may provide some protection beyond the targeted disease, including respiratory infections. However, individuals with MS should consult their physician before considering this type of vaccine, since live vaccines are not recommended for people with MS.

The effectiveness of a COVID-19 vaccine may possibly be compromised if taking a lymphocyte-depleting immunosuppressant medication to treat your MS. However, this has yet to be determined. Please consult your physician if you have any questions or concerns.

Based on findings published in the journal Virus Evolution, a team of Berlin researchers predicts COVID-19 vaccines will need regular updates, or boosters, much like seasonal flu vaccines. Because of the rapid development of new variants, the researchers predict that vaccine updates will be necessary until we get the pandemic under control. Mitigation measures and widespread vaccination will slow the spread and reduce the opportunity for COVID-19 variants to develop. This will help reduce the need for vaccine updates in the long run.

Researchers are trying to determine how long immunity lasts once you’ve been vaccinated. While the answer is yet to be determined, there appears to be variation between vaccines.

Herd Immunity

When approximately 70% of the population has been infected or inoculated via mass vaccination, ‘herd immunity’ is thought to possibly hinder the spread of COVID-19.  A study published in The Lancet Microbe finds that COVID-19 immunity varies greatly and could last from days to decades.

As of December 2021, 71% of the population in the United States have had at least one vaccination against COVID-19. For current figures, please see the CDC’s COVID Data Tracker.

Vaccines and wearing masks are the most humane path toward safely and rapidly reaching herd immunity.

A report published in the journal Nature, makes a case for a systematic and gradual re-opening of the economy as more of the population become vaccinated.

FDA provides guidelines on how to stop the spread and get us closer to our goal of a post-pandemic life.


Testing

Testing

Most people have mild symptoms and can recover safely at home, but testing may help you make informed decisions about self-isolation.

If you may have been exposed to COVID-19, contact state or local health departments or your healthcare provider to learn about available COVID-19 tests.

The FDA has provided a fact sheet if you are deciding which COVID-19 test to use.

On December 15, 2020, the FDA authorized the first over-the-counter (no prescription needed) rapid, fully at-home COVID-19 test. The National Institutes of Health provide an overview of its support of at-home testing.

A study published in December 2020 in the journal Health Affairs reports that aggressive and wide-spread testing, contact-tracing, and isolating exposed individuals appears to be the most effective measures for reducing COVID-19 transmission, more so than any other measures, including lockdowns. Accurate, readily available, and easy-to-use diagnostic tests play a crucial role in the fight to control the spread of the virus.

In February 2021, the FDA approved the first at-home, non-prescription molecular COVID-19 test. This could help make international travel easier as many countries require molecular test results within 72 hours and most rapid tests that return results in that timeframe are antigen only.

The CDC advises that you contact your state or local health department to learn about safety measures put in place in your own community.

Check here for the latest COVID-19 statistics.