Treatment options and Vaccines updates of COVID-19

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Currently, there is no specific antiviral treatment that has been confirmed to be effective against COVID-19. The main goal of therapy is to provide appropriate symptomatic treatment and supportive care to patients who are infected with the novel coronavirus. Some of the common interventions include:

• Oxygen therapy: This is the administration of oxygen to patients who have low blood oxygen levels due to COVID-19. Oxygen can be delivered through various devices, such as nasal cannula, face mask, or mechanical ventilator. Oxygen therapy can help improve the oxygenation and ventilation of the lungs and reduce the risk of respiratory failure and death .
• Extracorporeal membrane oxygenation (ECMO): This is a life-support technique that uses a machine to pump blood outside the body and pass it through an artificial lung that adds oxygen and removes carbon dioxide. ECMO can be used for patients who have severe respiratory distress syndrome (ARDS) or refractory hypoxemia (low blood oxygen that does not respond to oxygen therapy) due to COVID-19. ECMO can provide temporary support for the lungs and allow them to rest and heal . However, ECMO is a complex and invasive procedure that requires specialized equipment and personnel, and it is associated with potential complications, such as bleeding, infection, and clotting.
• Convalescent plasma and immunoglobulin G: These are therapies that use antibodies from the blood of people who have recovered from COVID-19 or who have been vaccinated against COVID-19. The antibodies can help neutralize the virus and enhance the immune response of the recipient. Convalescent plasma and immunoglobulin G have been used for some critical cases of COVID-19 according to their conditions . However, the evidence for their efficacy and safety is still limited and inconclusive .

These therapies are mainly aimed at alleviating the symptoms and preventing the progression of COVID-19. They do not directly target the virus or stop its replication. Therefore, there is a need for more specific and effective antiviral treatments that can reduce the viral load, shorten the duration of illness, prevent complications, and improve survival outcomes for patients with COVID-19.

Immunoglobulin G (IgG) is the most abundant type of antibody in human blood and plays a key role in providing long-term protection against viral infections. IgG antibodies are produced by the immune system after exposure to a specific antigen, such as the SARS-CoV-2 virus that causes COVID-19. IgG antibodies can neutralize the virus by binding to its surface proteins and preventing it from entering or infecting cells. IgG antibodies can also activate other immune cells and molecules to eliminate the virus and infected cells.

The detection of IgG antibodies in the blood of patients with COVID-19 can indicate a past or recent infection and a potential immunity to the virus. Several studies have reported the kinetics and characteristics of IgG responses in patients with COVID-19 using different methods and antigens. 1, 2, 3

One study used a magnetic chemiluminescence enzyme immunoassay (MCLIA) to measure IgG antibodies against the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein in 285 patients with COVID-19. The study found that 100% of the patients tested positive for IgG within 19 days after symptom onset, and that IgG titers plateaued within 6 days after seroconversion. The study also found that IgG titers were higher in severe cases than in non-severe cases, suggesting a correlation between IgG levels and disease severity. 1

Another study used an enzyme-linked immunosorbent assay (ELISA) to measure IgG antibodies against the nucleocapsid (N) protein of SARS-CoV-2 in 173 patients with COVID-19. The study found that 93.1% of the patients tested positive for IgG within 20 days after symptom onset, and that IgG titers increased over time and reached a peak at around 6 weeks after symptom onset. The study also found that IgG titers were higher in older patients than in younger patients, suggesting an age-dependent IgG response. 2

A third study used a chemiluminescence immunoassay (CLIA) to measure IgG antibodies against the RBD of the SARS-CoV-2 spike protein in 87 patients with COVID-19. The study found that 96.8% of the patients tested positive for IgG within 28 days after symptom onset, and that IgG titers were stable over time and did not decline significantly after 8 weeks after symptom onset. The study also found that IgG titers were higher in severe cases than in mild cases, suggesting a positive association between IgG levels and disease severity. 3

These studies demonstrate that IgG antibodies are detectable in most patients with COVID-19 within a few weeks after symptom onset, and that IgG levels may reflect the severity and duration of the infection. However, more studies are needed to determine the specificity, sensitivity, and accuracy of different IgG assays, as well as the protective efficacy and durability of IgG antibodies against SARS-CoV-2.

Currently, there is no specific antiviral treatment that has been confirmed to be effective against COVID-19. However, there are several treatment options available for people who have mild to moderate COVID-19 and are at high risk of developing severe illness or complications. These treatments can help reduce the viral load, prevent hospitalization and death, and improve recovery time. Some of these treatments are approved by the FDA, while others are authorized for emergency use under certain conditions.

The treatment options for COVID-19 include:

• Paxlovid (a combination of two medications, nirmatrelvir and ritonavir): This is an oral antiviral pill that can be taken at home within five days of the onset of symptoms. It works by blocking the activity of an enzyme that the virus needs to replicate. It has been shown to reduce the risk of hospitalization or death by 89% compared to placebo .
• Lagevrio (molnupiravir): This is another oral antiviral pill that can be taken at home within five days of the onset of symptoms. It works by introducing errors into the viral genome, preventing it from multiplying. It has been shown to reduce the risk of hospitalization or death by 30% compared to placebo .
• Veklury (remdesivir): This is an intravenous (IV) antiviral drug that can be given in both hospitalized and non-hospitalized settings. It works by interfering with the virus`s ability to copy its genetic material. It has been approved by the FDA for adults and certain pediatric patients with COVID-19 .
• Olumiant (baricitinib) and Actemra (tocilizumab): These are immune modulators that can be given to certain hospitalized adults with COVID-19 who have inflammation and low oxygen levels. They work by blocking the signals that cause the immune system to overreact and damage the organs. They have been approved by the FDA for use in combination with Veklury .
• Sotrovimab (Xevudy): This is a monoclonal antibody that can be given as an IV infusion or injection to certain non-hospitalized adults and children with mild to moderate COVID-19 who are at high risk of progressing to severe illness or hospitalization. It works by attaching to the spike protein of the virus and preventing it from entering the cells. It has been authorized for emergency use by the FDA .

These treatments are not a substitute for vaccination against COVID-19, which is the best way to prevent infection and severe illness. If you have been diagnosed with COVID-19 and are symptomatic, contact your health care provider as soon as possible to see whether these treatment options are right for you based on your symptoms, risks and health history.

Remdesivir is an antiviral drug that was originally developed to treat Ebola and other viral infections. It works by blocking the enzyme that the virus uses to copy its genetic material, thus preventing it from multiplying and spreading in the body. Remdesivir has shown activity against SARS-CoV-2, the virus that causes COVID-19, in laboratory and animal studies .

Remdesivir is the first and only drug that has been approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in adults and children aged 12 years and older who weigh at least 40 kg (about 88 pounds) and require hospitalization. It is given by intravenous infusion over 30 to 120 minutes. The recommended dose is 200 mg on the first day, followed by 100 mg once daily for up to 10 days.

Remdesivir has been studied in several clinical trials for the treatment of COVID-19. The most important one was a randomized, placebo-controlled trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) that enrolled more than 1000 hospitalized patients with moderate to severe COVID-19. The results showed that remdesivir shortened the time to recovery by an average of four days (11 days versus 15 days) and reduced the risk of death by 30% (6.7% versus 11.9%) compared to placebo. However, these differences were not statistically significant, meaning that they could have occurred by chance.

Another randomized, placebo-controlled trial conducted by the World Health Organization (WHO) enrolled more than 11,000 hospitalized patients with COVID-19 and compared remdesivir with three other antiviral drugs (hydroxychloroquine, lopinavir/ritonavir, and interferon beta-1a) and placebo. The results showed that none of the drugs had a significant effect on reducing mortality, preventing the need for mechanical ventilation, or shortening the time to clinical improvement compared to placebo.

Remdesivir is generally well tolerated, but it can cause some side effects such as nausea, vomiting, liver enzyme elevation, allergic reactions, and blood clotting abnormalities. Before starting remdesivir, patients should have their kidney function, liver function, and blood clotting tests checked and monitored during treatment as needed. Remdesivir may interact with some other drugs, so patients should inform their health care providers about all the medications they are taking.

Remdesivir is not a cure for COVID-19, but it may help some patients recover faster and reduce their risk of dying from the disease. However, more research is needed to confirm its effectiveness and safety in different populations and settings. Remdesivir should be used only under the supervision of a health care provider and according to the FDA-approved label or clinical trial protocols.

Chloroquine (Hydroxychloroquine) is another repurposed drug that shows great potential for the treatment of COVID-19. Chloroquine has been in use for many years for the treatment of malaria, with a mechanism not well understood against some viral infections. It has been assumed that chloroquine can inhibit pH-dependent steps of the replication of several viruses, with a potent effect on infection and the spread of SARS-CoV-2. Moreover, chloroquine has immunomodulatory effects, suppressing the production/release of TNF-α and IL-6 and also works as a novel class of autophagy inhibitor, which may interfere with viral infection and replication. Several studies have found that chloroquine interfered with the glycosylation of cellular receptors of SARS-CoV and functioned at both entry and post-entry stages of the COVID-19 infection in Vero E6 cells. A combination of remdesivir and chloroquine was proven to inhibit the recently emerged SARS-CoV-2 in vitro effectively.

However, top experts do not recommend using chloroquine or hydroxychloroquine to treat COVID-19. The risks of taking them outweigh the possible benefits. The COVID-19 Treatment Guidelines Panel recommends against the use of chloroquine and hydroxychloroquine for the treatment of COVID-19 in patients. The ruling came after the FDA expressed concerns about the drugs` safety and how well they worked against the virus after earlier studies showed they promise in preventing hospitalization. Doctors had thought chloroquine might reduce how long people with mild-to-moderate COVID-19 symptoms feel sick but instead found that they ran the risk of serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure. A meta-analysis of randomized trials also found that hydroxychloroquine was associated with increased mortality in COVID-19 patients

Remdesivir and chloroquine are two antiviral drugs that have shown some promise for the treatment of COVID-19. Remdesivir is a nucleotide analog that inhibits the viral RNA polymerase and terminates viral replication. Chloroquine is an old anti-malarial drug that has multiple mechanisms of action against SARS-CoV-2, such as interfering with viral entry, inhibiting viral replication, and modulating the immune response.

A combination of remdesivir and chloroquine was proven to inhibit the recently emerged SARS-CoV-2 in vitro effectively. A clinical study also showed that this combination was highly effective in controlling SARS-CoV-2 infection in patients with mild to moderate COVID-19. However, the FDA has warned of a potential drug interaction that may reduce the effectiveness of remdesivir when co-administered with chloroquine or hydroxychloroquine. The FDA recommends avoiding this combination until more data are available on its safety and efficacy.

Therefore, the role of remdesivir and chloroquine combination therapy for COVID-19 remains uncertain and requires further investigation in clinical trials.

: Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020;55(4):105932. doi:10.1016/j.ijantimicag.2020.105932

Lopinavir and ritonavir are protease inhibitors that are used to treat HIV infection. They have been suggested as potential antiviral agents for COVID-19, based on their ability to inhibit the 3C-like protease enzyme of SARS-CoV-2, which is essential for viral replication .

However, the evidence from randomized controlled trials (RCTs) on the efficacy and safety of lopinavir-ritonavir for COVID-19 is limited and inconsistent. A systematic review of seven RCTs comparing lopinavir-ritonavir with different control interventions (supportive care, umifenovir, novaferon, or a combination of interferon beta 1b and ribavirin) in 250 adult inpatients with COVID-19 found no significant difference in mortality, virological cure, radiological improvement, or adverse events between lopinavir-ritonavir and supportive care. Similarly, no difference was observed for any efficacy outcomes between lopinavir-ritonavir and other control interventions. However, lopinavir-ritonavir was associated with a significantly higher risk of adverse events than umifenovir.

Another RCT of 1,616 patients hospitalized with COVID-19 in the UK also found no evidence that lopinavir-ritonavir reduced mortality, duration of hospital stay, or risk of mechanical ventilation compared with usual care. The trial was stopped early due to lack of clinical benefit. The most common adverse events reported with lopinavir-ritonavir were gastrointestinal symptoms, such as nausea, vomiting, and diarrhea.

Therefore, based on the current evidence, there is no benefit of adding lopinavir-ritonavir to the standard care in COVID-19 patients. More high-quality RCTs are needed to confirm or refute the role of lopinavir-ritonavir in the treatment of COVID-19.

Chloroquine and hydroxychloroquine are two drugs that have been used for decades to treat malaria and some autoimmune diseases. They were also granted an emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) in March 2020 to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable or not feasible.

However, on June 15, 2020, the FDA revoked the EUA for these drugs based on new scientific data and analysis. The FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA, and that the potential benefits of these drugs do not outweigh the known and potential risks.

Some of the risks associated with chloroquine and hydroxychloroquine include serious cardiac adverse events, such as heart rhythm problems, low blood pressure, and cardiac arrest. Other possible side effects include liver damage, nerve damage, vision problems, and blood disorders.

The FDA also stated that the suggested dosing regimens for these drugs are unlikely to produce an antiviral effect against SARS-CoV-2, the virus that causes COVID-19. Moreover, recent clinical trials have shown no evidence of benefit of these drugs in reducing mortality or improving other outcomes in hospitalized COVID-19 patients.

The decision to revoke the EUA was made in consultation with the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services, which had originally requested the EUA. The FDA emphasized that it will continue to monitor the emerging scientific data on COVID-19 treatments and vaccines, and will update its recommendations accordingly.

The revocation of the EUA does not affect the FDA-approved uses of chloroquine and hydroxychloroquine for malaria, lupus, and rheumatoid arthritis. However, the FDA advised health care professionals to carefully consider the potential risks and benefits of these drugs before prescribing them for these conditions.

The revocation of the EUA also does not prevent clinical trials from continuing to evaluate these drugs for COVID-19. The FDA encouraged researchers to conduct well-designed randomized controlled trials to generate more data on the safety and efficacy of these drugs for COVID-19.

Ivermectin is an FDA-approved antiparasitic drug that has been shown to have antiviral activity against some RNA viruses in vitro, including SARS-CoV-2. However, the plasma concentrations required to achieve this effect are much higher than those achieved with the approved doses of ivermectin. Therefore, the clinical relevance of this finding is uncertain.

Several clinical trials and observational studies have evaluated the use of ivermectin for the prevention and treatment of COVID-19, but the results have been inconsistent and inconclusive . Some studies have reported a possible benefit of ivermectin in reducing mortality, viral load, or disease severity, while others have found no difference or even harm compared to standard care or placebo .

The COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of ivermectin for the treatment of COVID-19, based on the lack of high-quality evidence from adequately powered, randomized trials that reported clinical outcomes. The Panel also notes that the safety and efficacy of ivermectin for the treatment of COVID-19 have not been approved by the FDA.

The World Health Organization (WHO) and the European Medicines Agency (EMA) also advise against using ivermectin for COVID-19, except in clinical trials . They warn that the use of ivermectin outside its approved indications may cause serious adverse effects, such as neurologic toxicity, liver injury, or drug interactions .

Ivermectin should only be used as prescribed by a health care provider for its approved indications, such as parasitic infections or skin conditions. It should not be used for self-medication or prevention of COVID-19. More research is needed to determine if ivermectin has any role in the management of COVID-19.

The development of safe and effective vaccines against COVID-19 has been one of the most remarkable achievements of science and public health in the face of the pandemic. As of June 2023, there are several authorized and recommended vaccines for COVID-19 in the United States, including:

• Pfizer-BioNTech mRNA vaccine, which is authorized for people aged 6 months and older, and requires two doses given 21 days apart, plus one updated booster dose given at least 4 months after the second dose.
• Moderna mRNA vaccine, which is authorized for people aged 6 months and older, and requires two doses given 28 days apart, plus one updated booster dose given at least 4 months after the second dose.
• Johnson & Johnson`s Janssen viral vector vaccine, which is authorized for people aged 12 years and older, and requires one dose, plus one updated booster dose given at least 2 months after the first dose.
• Novavax protein subunit vaccine, which is authorized for people aged 12 years and older, and requires two doses given 21 days apart.

The updated booster doses of Pfizer-BioNTech and Moderna vaccines are designed to provide better protection against the omicron variant of COVID-19, which has emerged as a dominant strain worldwide. The updated booster doses contain a new mRNA component that matches the spike protein of the omicron variant, as well as the original mRNA component that provides broad protection against other variants.

The updated booster doses of Johnson & Johnson`s Janssen and Novavax vaccines are also expected to enhance immunity against the omicron variant, but they have not yet been authorized by the FDA as of June 2023.

The CDC recommends that everyone aged 6 years and older should get one updated booster dose of Pfizer-BioNTech or Moderna vaccine to be considered up to date with COVID-19 vaccination. Additionally, some people may get additional updated booster doses, such as:

• People aged 65 years and older may get one additional updated booster dose of Pfizer-BioNTech or Moderna vaccine at least 4 months after the first updated booster dose.
• People who are moderately or severely immunocompromised may get one additional updated booster dose of Pfizer-BioNTech or Moderna vaccine at least 2 months after the first updated booster dose.

Children aged 6 months to 5 years may need multiple doses of COVID-19 vaccine to be up to date, depending on their age and the number of doses they have previously received. For example:

• Children aged 6 months to 4 years who received Pfizer-BioNTech vaccine should get three doses, including at least one updated booster dose.
• Children aged 5 years who received Pfizer-BioNTech vaccine should get at least one updated booster dose.
• Children aged 6 months to 5 years who received Moderna vaccine should get two doses, including at least one updated booster dose.

People who are unable or choose not to get an updated mRNA vaccine can consider other options to get up to date with COVID-19 vaccination, such as:

• Novavax vaccine, which is authorized for people aged 12 years and older, and requires two doses given 21 days apart.
• Johnson & Johnson`s Janssen vaccine, which is authorized for people aged 12 years and older, and requires one dose, plus one updated booster dose given at least 2 months after the first dose.

COVID-19 vaccines are safe, effective, and free. They can protect you from getting seriously ill, being hospitalized, or dying from COVID-19. They can also reduce the risk of spreading the virus to others. To find COVID-19 vaccine locations near you, visit http://vaccines.gov/ or text your ZIP code to 438829.

COVID-19 vaccine recommendations will be updated as needed based on new evidence and data. For more information about COVID-19 vaccines, visit http://cdc.gov/coronavirus/2019-ncov/vaccines/index.html.%3C/p>

Other COVID-19 Vaccine Options

If you are unable or choose not to get an updated Pfizer-BioNTech or Moderna COVID-19 vaccine, you may consider other options to get up to date with your COVID-19 vaccination. According to the CDC, these options include:

• Novavax: This is a protein-based vaccine that has shown to be safe and effective in clinical trials. It is expected to be authorized by the FDA soon. You will need two doses of this vaccine, given 21 days apart, to be fully vaccinated. This vaccine can be used by people 12 years and older.
• Johnson and Johnson`s Janssen: This is a viral vector vaccine that uses a modified version of a different virus to deliver instructions to your cells. It has been authorized by the FDA since February 2021. You will need one dose of this vaccine to be fully vaccinated. This vaccine can be used by people 18 years and older.

These vaccines are also effective at preventing severe illness, hospitalization, and death from COVID-19. However, they may have different levels of protection against new variants of the virus. You should talk to your healthcare provider about the best vaccine option for you based on your medical history and preferences.

You can find COVID-19 vaccine locations near you by searching http://vaccines.gov/, texting your ZIP code to 438829, or calling 1-800-232-0233.

Bivalent COVID-19 Vaccines

On August 31, 2022, the U.S. Food and Drug Administration (FDA) authorized the use of bivalent COVID-19 vaccines, or updated boosters, from Moderna and Pfizer-BioNTech for people aged 6 years and older. These vaccines are designed to provide better protection against the omicron variant of SARS-CoV-2, which was first detected in late 2021 and has since become the dominant strain worldwide.

The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The updated boosters are administered as a single dose at least four months after completing the primary series of any authorized or approved COVID-19 vaccine.

According to the FDA, the bivalent COVID-19 vaccines have met the statutory criteria for safety and effectiveness and have shown to be 85% effective at preventing symptomatic COVID-19 caused by the omicron variant in clinical trials. The most common side effects reported after receiving the updated boosters were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, fever and joint pain. These side effects were generally mild to moderate and lasted for a few days.

The FDA also authorized the use of Novavax COVID-19 vaccine as another option for people aged 12 years and older who are unable or choose not to get an updated mRNA COVID-19 vaccine. The Novavax COVID-19 vaccine is a protein-based vaccine that contains a recombinant spike protein antigen derived from the original strain of SARS-CoV-2 and an adjuvant that enhances the immune response. The Novavax COVID-19 vaccine is administered as two doses given 21 days apart.

The CDC recommends that everyone aged 6 years and older should get one updated Pfizer-BioNTech or Moderna COVID-19 vaccine to be considered up to date. People aged 65 years and older may get a second updated Pfizer-BioNTech or Moderna COVID-19 booster dose four or more months after the first updated COVID-19 vaccine. People who are moderately or severely immunocompromised may get additional updated Pfizer-BioNTech or Moderna COVID-19 booster doses two or more months after the first updated COVID-19 vaccine. Children aged 6 months–5 years may need multiple doses of COVID-19 vaccine to be up to date, including at least one updated dose of Pfizer-BioNTech or Moderna COVID-19 vaccine, depending on the number of doses they’ve previously received and their age.

On August 31, 2022, the U.S. Food and Drug Administration (FDA) authorized the use of bivalent COVID-19 vaccines, or updated boosters, from Moderna and Pfizer-BioNTech for people aged 6 years and older. These vaccines are designed to provide better protection against the omicron variant of SARS-CoV-2, which was first detected in late 2021 and has since become the dominant strain worldwide.

The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The updated boosters are administered as a single dose at least four months after completing the primary series of any authorized or approved COVID-19 vaccine.

According to the FDA, the bivalent COVID-19 vaccines have met the statutory criteria for safety and effectiveness and have shown to be 85% effective at preventing symptomatic COVID-19 caused by the omicron variant in clinical trials. The most common side effects reported after receiving the updated boosters were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, fever and joint pain. These side effects were generally mild to moderate and lasted for a few days.

The FDA also authorized the use of Novavax COVID-19 vaccine as another option for people aged 12 years and older who are unable or choose not to get an updated mRNA COVID-19 vaccine. The Novavax COVID-19 vaccine is a protein-based vaccine that contains a recombinant spike protein antigen derived from the original strain of SARS-CoV-2 and an adjuvant that enhances the immune response. The Novavax COVID-19 vaccine is administered as two doses given 21 days apart.

The CDC recommends that everyone aged 6 years and older should get one updated Pfizer-BioNTech or Moderna COVID-19 vaccine to be considered up to date. People aged 65 years and older may get a second updated Pfizer-BioNTech or Moderna COVID-19 booster dose four or more months after the first updated COVID-19 vaccine. People who are moderately or severely immunocompromised may get additional updated Pfizer-BioNTech or Moderna COVID-19 booster doses two or more months after the first updated COVID-19 vaccine. Children aged 6 months–5 years may need multiple doses of COVID-19 vaccine to be up to date, including at least one updated dose of Pfizer-BioNTech or Moderna COVID-19 vaccine, depending on the number of doses they’ve previously received and their age.

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