What is COVID-19?
COVID-19 is the disease caused by an infection of the SARS-CoV-2 virus, first identified in the city of Wuhan, in China's Hubei province in December 2019. COVID-19 was previously known as 2019 Novel Coronavirus (2019-nCoV) respiratory disease before the World Health Organization (WHO) declared the official name as COVID-19 in February 2020.
The SARS-CoV-2 virus belongs to the family of viruses called coronaviruses, which also includes the viruses that cause the common cold, and the viruses that cause more serious infections such as severe acute respiratory syndrome (SARS), which was caused by SARS-CoV in 2002, and Middle East respiratory syndrome (MERS), which was caused by MERS-CoV in 2012. Like the other coronaviruses, the SARS-CoV-2 virus primarily causes respiratory tract infections, and the severity of the COVID-19 disease can range from mild to fatal.
Serious illness from the infection is caused by the onset of pneumonia and acute respiratory distress syndrome (ARDS).
Stay up to date on COVID-19
COVID-19 Vaccines Available Under FDA Emergency Use Authorization (EUA)
- Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)
Vaccine platform: mRNA vaccine
BNT162b2 is a nucleoside-modified messenger RNA (modRNA) that encodes the viral spike (S) glycoprotein of SARS-CoV-2. The FDA granted Emergency Use Authorization (EUA) for BNT162b2 on December 11, 2020 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. On May 10, 2021, the FDA amended the EUA to include adolescents 12 through 15 years of age.
- Moderna COVID-19 Vaccine (mRNA-1273)
Vaccine platform: mRNA vaccine
mRNA-1273 is an mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein of SARS-CoV-2. The FDA granted Emergency Use Authorization (EUA) for mRNA-1273 on December 18, 2020 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
- Johnson & Johnson COVID-19 Vaccine (Ad26.COV2-S)
Vaccine platform: Non-Replicating Viral Vector
Ad26.COV2-S is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses the SARS-CoV-2 spike (S) antigen to elicit an immune response and protect against COVID-19. The FDA granted Emergency Use Authorization (EUA) for Ad26.COV2-S on February 27, 2021 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
The most common symptoms of COVID-19 include dry cough, fever, and shortness of breath. It is thought that symptoms can appear between 2-14 days after exposure although there have been isolated cases which suggest this may be longer. If you develop symptoms, you should stay at home to prevent the spread of the disease into the community. Wearing a face mask will help prevent the spread of the disease to others.
According to the Centers for Disease Control and Prevention (CDC), symptoms of COVID-19 include:
- fever or chills
- shortness of breath or difficulty breathing
- muscle or body aches
- new loss of taste or smell
- sore throat
- congestion or runny nose
- nausea or vomiting
The SARS-CoV-2 virus is thought to spread from person-to-person via:
- droplet transmission (large respiratory droplets that people sneeze, cough or drip)
- aerosol transmission (when someone coughs or sneezes in the room, aerosolized droplets from talking and singing)
- contact transmission (touching a contaminated surface then touching your mouth, nose or eyes)
- direct transmission (kissing, shaking hands etc.)
The best way to prevent infection is to avoid exposure to the virus.
The most important way to prevent COVID-19 is to WASH YOUR HANDS.
Wash your hands regularly and thoroughly with soap and water (lather for 20 seconds) OR use an alcohol based (at least 60%) hand sanitizer.
Other actions that help to prevent the spread of COVID-19:
- avoid contact with others who are sick
- avoid touching your mouth, nose, eyes or face
- cover coughs and sneezes (into a tissue or into your elbow)
- clean and disinfect surfaces (alcohol or bleach based cleaning solutions work best for coronaviruses)
- face masks will not protect you from COVID-19 directly, but can help reduce your risk of exposure to the virus, remind you to avoid touching your face, and will help prevent the spread of the disease to others
- social distancing
- self isolation
Boosting your immune system with dietary supplements (vitamin D, vitamin C, vitamin B complex, quercetin, zinc) may help prevent severe COVID-19.
What to do if you are sick
What to do if you come into contact with someone who is sick
Stay at home. If you have been exposed to someone who has tested positive for COVID-19, or someone who is showing symptoms of COVID-19, it may take up to two weeks for your symptoms to present. To keep yourself and others safe, you should isolate yourself from other people for 14 days.
Scientists are still researching risk factors for COVID-19 but data from China CDC suggest that the elderly, and people suffering from pre-existing medical conditions (such as heart disease, respiratory disease including asthma and COPD, or diabetes) have a higher risk of dying from the disease. There is research that suggests that smokers may be more susceptible to the SARS-CoV-2 virus. There is also evidence to suggest that people who use e-cigarettes (vaping) are at much higher risk of developing serious respiratory infections.
March 16, 2020 -- A Chinese study claims to have found that people with type A blood may be more susceptible to the novel Coronavirus (COVID-19).
March 22, 2020 -- CDC now includes people aged 65 years and older, people who live in a nursing home or long-term care facility, and people who are immunocompromised including those receiving cancer treatment as those who are at higher risk for severe illness. People with HIV may also be at higher risk of serious illness.
- Remdesivir is an antiviral drug with broad-spectrum antiviral activity. On October 22, 2020, the FDA approved remdesivir under the brand name Veklury for the treatment of hospitalized COVID-19 patients 12 years of age and older.
- Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It was granted FDA Emergency Use Authorization (EUA) on November 9, 2020 for the treatment of recently diagnosed COVID-19. The FDA revoked the EUA for bamlanivimab monotherapy on April 16, 2021.
- Casirivimab and Imdevimab (REGN-COV2) is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It was granted FDA Emergency Use Authorization on November 21, 2020 for the treatment of mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19.
- Bamlanivimab and Etesevimab (LY-CoV555 and LY-CoV016) is a combination of two monoclonal antibodies that work to block the infectivity of the SARS-CoV-2 virus. It was granted Emergency Use Authorization on February 9, 2021 for the treatment of mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19.
- Sotrovimab is a monoclonal antibody designed to block SARS-CoV-2 viral entry into healthy cells and clear infected cells in patients with COVID-19. It was granted Emergency Use Authorization on May 26, 2021 for the treatment of mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19.
- AZD7442: A long-acting antibody (LAAB) combination called AZD7442 is currently being evaluated for the prevention and treatment of COVID-19 in late-stage trials in more than 9,000 participants around the world.
- Baricitinib: Phase 3 studies are in progress to determine the effectiveness of a Janus kinase (JAK) inhibitor called baricitinib (marketed under the brand name Olumiant for the treatment of rheumatoid arthritis) in the treatment of COVID-19 patients. On November 19, 2020, Eli Lilly announced FDA Emergency Use Authorization for baricitinib in combination with remdesivir for use in hospitalized patients with COVID-19.
- Bemcentinib: An AXL kinase inhibitor called bemcentinib has been fast-tracked in a UK Phase II clinical trial to study its effectiveness in the treatment of hospitalized patients with COVID-19. Bemcentinib has previously been studied in cancer patients and has been shown to be safe and well-tolerated. It has also been reported to exhibit potent antiviral activity in preclinical models against several enveloped viruses, including Ebola and Zika virus, and recent data have expanded this to include SARS-CoV-2.
- Bevacizumab: A VEGF inhibitor called bevacizumab (marketed under the brand name Avastin for certain types of cancer) being studied as a treatment for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in critically ill patients with COVID-19 pneumonia at the Qilu Hospital of Shandong University in Jinan, China.
- Chloroquine phosphate: The older anti-malaria drug chloroquine has been shown to have a wide range of antiviral effects, including anti-coronavirus. Studies in Guangdong Province in China suggest that chloroquine may help improve patient outcomes in people with novel coronavirus pneumonia.
- Colchicine: An older anti-inflammatory drug called colchicine is being studied to prevent complications of COVID-19 in high risk patients. Colchicine has long been used in the treatment of gout.
- Convalescent Plasma: On August 23, 2020, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19. The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness patients who are hospitalized with COVID-19.
- Dexamethasone: The cheap and widely available steroid dexamethasone reduced the risk for death among seriously ill COVID-19 patients by up to a third, according to researchers at the University of Oxford in England. The drug did not appear to help patients with less serious illness.
- Favipiravir: An antiviral drug called favipiravir which was reported February 17, 2020 to have received marketing approval in China for the treatment of influenza, was also approved for use in clinical trials as a treatment for novel coronavirus pneumonia. On March 31, 2020, Fujifilm announced the start of a Phase 3 clinical trial of Avigan (favipiravir) on COVID-19 patients in Japan. Avigan is approved in Japan for use as an antiviral in the treatment of influenza. On April 9, 2020 -- Fujifilm announced the start of a Phase 2 clinical trial of favipiravir in approximately 50 COVID-19 patients in the U.S. On June 19, 2020, Glenmark Pharmaceuticals Limited announced the marketing approval of favipiravir (FabiFlu®) for the treatment of mild to moderate COVID-19 patients in India.
- Fingolimod: An approved drug called fingolimod (marketed under the brand name Gilenya for the treatment of relapsing forms of multiple sclerosis) is being studied as a treatment for COVID-19 at the First Affiliated Hospital of Fujian Medical University in Fuzhou, China.
- Fluvoxamine: The selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine may work to prevent serious illness in COVID-19 patients who aren't yet hospitalized according to a small study.
- Hydroxychloroquine and azithromycin: In a small study commissioned by the French government, 20 patients with COVID-19 were treated with a combination of the anti-malaria drug hydroxychloroquine and the macrolide antibacterial drug azithromycin (Zithromax). Results showed that all patients taking the combination were virologically cured within 6 days of treatment.
Addition of Zinc May Benefit Some Being Treated for COVID-19 May 13, 2020
NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19 (NIH Press Release) May 14, 2020
- Hydroxychloroquine sulfate: It was reported in the journal Clinical Infectious Diseases on March 9 that the malaria drug hydroxychloroquine was effective in killing the coronavirus in laboratory experiments. Hydroxychloroquine was first approved by the FDA in 1995 under the brand name Plaquenil, and it is also used in the treatment of patients with lupus and arthritis. In March 2020, the US FDA issued an emergency use authorization (EUA) to allow the emergency use of hydroxychloroquine sulfate supplied from the Strategic National Stockpile (SNS) for the treatment of COVID-19 in certain hospitalized patients. On June 15, 2020, the FDA revoked the EUA.
- Ivermectin: An anti-parasitic drug called ivermectin is currently being investigated as a treatment for coronavirus SARS-CoV-2, which is the virus that causes COVID-19. The FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. The World Health Organization (WHO) recommend not to use ivermectin in patients with COVID-19, except in clinical trials.
- Leronlimab: A CCR5 antagonist called leronlimab has shown promise in calming the 'cytokine storm' in a small number of critically ill COVID-19 patients hospitalized in the New York area.
- Lopinavir and ritonavir: A drug combination called lopinavir/ritonavir approved to treat HIV under the brand name Kaletra is being studied in combination with the flu drug oseltamivir (Tamiflu) in Thailand. It was reported on February 18, 2020 that an elderly Chinese woman, the first patient to receive the "Thai cocktail" in Bangkok's Rajvithi Hospital, had made a complete recovery after suffering from severe COVID-19-related pneumonia. On March 18, 2020, a study in the New England Journal of Medicine reported the lopinavir/ritonavir combination showed no benefit over standard care in hospitalized adult patients with severe COVID-19.
- Methylprednisolone: A widely used glucocorticoid called methylprednisolone is being studied for safety and effectiveness in the treatment of novel coronavirus pneumonia in a number of hospitals in the Hubei province of China.
- MK-7110 (formerly CD24Fc): is a potentially first-in-class investigational recombinant fusion protein. It works by modulating the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. In April 2021, Merck announced the the discontinuation of the development of MK-7110
- Molnupiravir (MK-4482): is an oral novel investigational antiviral agent being developed by Merck in collaboration with Ridgeback Bio. Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. The primary completion date for the Phase 2/3 studies is May 2021.
- Peginterferon Lambda: A single dose of the experimental antiviral drug peginterferon Lambda accelerated the clearance of SARS-CoV2 in newly diagnosed, non-hospitalized patients according to the results of a Phase 2 study published in Lancet Respiratory Medicine.
- PF-07321332: Pfizer announced the initiation of a Phase 1 study of PF-07321332, an oral SARS-CoV2-3CL protease inhibitor which has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses.
- RLF-100: (aviptadil) is a formulation of vasoactive intestinal polypeptide (VIP) which binds to alveolar type 2 cells in the lungs inhibiting pro-inflammatory cytokines. On August 6, 2020, Relief Therapeutics announced that it had been granted Investigational New Drug (IND) permission to test RLF-100 for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure.
- Sarilumab: An interleukin-6 (IL-6) receptor antagonist called sarilumab (marketed under the brand name Kevzara for the treatment of rheumatoid arthritis) is being studied as a potential treatment for acute respiratory distress syndrome (ARDS) in patients critically ill from COVID-19.
- STC3141: An investigational drug called STC3141 has been approved to commence phase II clinical research in Australia for the treatment of acute respiratory distress syndrome (ARDS) suffered by COVID-19 patients.
- Tocilizumab: An interleukin-6 receptor antagonist called tocilizumab (marketed under the brand name Actemra for the treatment of rheumatoid arthritis and other inflammatory conditions) is being studied in a number of locations worldwide for the treatment of patients with COVID-19.
- Umifenovir: An antiviral drug called umifenovir (marketed in Russia under the brand name Arbidol, and also available in China for the treatment of influenza) is being studied in China and other countries as a treatment for COVID-19.
Several pharmaceutical companies and research organizations worldwide are involved in the development of potential vaccines.
- AZD1222 (formerly ChAdOx1 nCoV-19) Vaccine platform: Non-Replicating Viral Vector
AZD1222 was developed by Oxford University’s Jenner Institute, with AstraZeneca responsible for development and worldwide manufacturing and distribution. A Phase I/II clinical trial of AZD1222 began in April 2020 to assess safety, immunogenicity and efficacy of the vaccine in over 1000 healthy volunteers across several trial centres in southern England. Interim results were published in The Lancet on July 20, 2020.
- INO-4800 Vaccine platform: DNA vaccine
Inovio Pharmaceuticals, Inc. announced on April 6, 2020 FDA acceptance of the Investigational New Drug (IND) application for its DNA vaccine candidate INO-4800, paving the way for a Phase 1 clinical trial. On June 30, 2020, the company announced positive interim clinical data from the Phase 1 trial, with plans to initiate a Phase 2/3 efficacy trial upon regulatory concurrence. On September 28, 2020, Inovio announced that the planned Phase 2/3 trial of INO-4800 has been put on partial clinical hold at the request of the FDA.
- Ad5-nCoV Vaccine platform: Adenovirus Type 5 Vector
CanSino Biologics Inc. has announced that its recombinant novel coronavirus vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV), co-developed with Beijing Institute of Biotechnology (BIB), has been approved to enter into a Phase 1 clinical trial in China. On June 29, 2020, the company announced the vaccine had received Military Specially-Needed Drug Approval in China.
- NVX-CoV2373 Vaccine platform: Protein Subunit
On May 25, 2020, Novavax, Inc. announced the commencement of a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology adjuvant (Matrix-M™) to enhance immune responses and stimulate high levels of neutralizing antibodies, across two sites in Australia. On July 7, 2020, the company announced that it had been selected to participate in Operation Warp Speed, with funding from the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial and the delivery of 100 million doses of NVX-CoV2373 as early as late 2020. On August 4, 2020, Novavax reported Phase 1 data from the Phase 1/2 randomized, observer-blinded, placebo-controlled trial of NVX-CoV2373 with and without Matrix-M™ adjuvant. On August 24, 2020, it was announced that Phase 2 trials had commenced, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites across the U.S. and Australia.
- CoronaVac Vaccine Platform: Inactivated
Sinovac Biotech Ltd. announced the commencement of a Phase I clinical trial for its COVID-19 vaccine candidate to be conducted in Jiangsu Province, China. On June 13, 2020, Sinovac reported positive preliminary results of the phase I/II clinical trial. On July 6, 2020, the company announced that the Brazilian National Regulatory Agency, Anvisa, had granted approval to conduct a phase III clinical trial of CoronaVac in Brazil.
- V590 and V591 Merck announced a collaboration with IAVI (International AIDS Vaccine Initiative) to develop an investigational vaccine against SARS-CoV-2, using the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for its Ebola Zaire virus vaccine (Ervebo). On January 25, 2021, the company announced that it was discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates (V590 and V591) and confirmed plans to switch focus instead to advancing its therapeutic candidates.
- SCB-2019 Vaccine platform: Protein Subunit
Clover Pharmaceuticals announced that the first participants have been dosed in the Phase 1 first-in-human study evaluating the company’s COVID-19 S-Trimer subunit vaccine candidate (SCB-2019) which is based on its proprietary Trimer-Tag© vaccine technology platform. The Phase I study will evaluate two adjuvant systems - GSK’s pandemic adjuvant system, and Dynavax’s CpG 1018 adjuvant combined with alum.
- COVAC1 Imperial College London announced that it has dosed the first healthy volunteer with its COVAC1 coronavirus vaccine candidate, which has been developed using the new self-amplifying RNA (saRNA) technology.
- GX-19 Vaccine platform: DNA vaccine
Genexine announced the approval of a clinical phase 1/2a trial of DNA vaccine GX-19 in Korea.
- CVnCoV Vaccine platform: mRNA vaccine
CureVac AG announced the approval of a Phase 1 clinical trial for its mRNA vaccine CVnCoV to be conducted in Germany and Belgium on June 17, 2020, and the launch of the Phase 2a trial to be conducted Peru and Panama on September 29, 2020.
- Sputnik V Vaccine platform: Non-Replicating Viral Vector
On September 4, 2020, it was announced that the results of the Phase I-II clinical trials of the Russian vaccine Sputnik V had been published in The Lancet. Results showed that Sputnik V generated a stable humoral and cellular immune response in 100% of trial participants, and showed no serious adverse events. Sputnik V uses two different vectors (based on human adenovirus serotypes Ad5 and Ad26) in two separate shots to achieve a more effective immune response.
- VXA-CoV2-1 An oral COVID-19 vaccine candidate from Vaxart, Inc. was selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed. The Phase 1 trial in humans commenced October 2020.
- An inactivated COVID-19 vaccine that is effective across against all detected strains of the virus so far is being developed by the Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology under the Chinese Academy of Sciences. Positive results from the Phase 1 and Phase 2 clinical studies were reported in June 2020, and the commencement of Phase 3 trial to be conducted in Abu Dhabi, UAE was announced in July 2020.
- BBIBP-CorV Beijing Institute of Biological Products/Sinopharm announced promising results of a small trial of their inactivated vaccine candidate BBIBP-CorV in volunteers aged between 18 to 80 years in October 2020.
- MRT5500 Vaccine platform: mRNA vaccine
On October 15, 2020 Sanofi Pasteur and Translate Bio announced preclinical results for the mRNA-based vaccine candidate MRT5500.
- In May 2020, the Trump Administration announced the framework and leadership for Operation Warp Speed, a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of the Department of Health and Human Services (HHS), including CDC, FDA, NIH, and BARDA.
- According to an article in The New York Times on June 3, 2020, the Trump Administration has selected five companies (Moderna Inc, AstraZeneca Plc, Pfizer Inc., Johnson & Johnson, and Merck & Co Inc.) as the most likely candidates to produce a vaccine for the novel coronavirus. HHS did not confirm or deny the report.
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