Regulators have put different COVID-19 treatments through different degrees of scrutiny, with some relatively safe treatments getting short shrift, while others get an accelerated approval. While vaccines experienced strong and unflinching support, monoclonal antibodies have had a rocky path to sometimes fleeting approvals. Other treatments, like ivermectin, never got approval in the United States but have been widely used elsewhere.
2020
January 9—WHO announces the emergence of an illness characterized by pneumonia associated with the new coronavirus SARS-CoV-2 (COVID-19) in Wuhan, China.January—Dr. Paul Marik, Founder of FLCCC, Professor of Medicine, and Chief of the Division of Pulmonary and Critical Care Medicine, creates a COVID-19 hospital protocol for his medical school at the Eastern Virginia Medical School in Norfolk, Virginia called the EVMS protocol, based on Dr. Marik’s safe, effective treatment protocol for sepsis, of intravenous hydrocortisone, ascorbic acid, and thiamine.
March 3—The Chinese regime’s National Health Commission & State Administration of Traditional Chinese Medicine (TCM) releases treatment protocol for “Novel Coronavirus Pneumonia” which includes protocols for oxygen therapy, antiviral therapy, and antibiotic drug treatment for general treatment, and convalescent plasma treatment, blood purification treatment, immunotherapy, and glucocorticoids for severe cases. Recommending traditional Chinese medicine, part of the clinical treatment includes lung cleansing and TCM detoxification.
March 11—WHO declares COVID-19 a pandemic.
March 17—University of Minnesota begins testing hydroxychloroquine.
March 30—FDA authorizes an EUA of hydroxychloroquine.
April 5—Intensivist colleagues from New York, Italy, and China meet to discuss Dr. Marik’s EVMS protocol, focusing on steroid use. FLCCC forms from this meeting.
April 8—President Trump says, “What do you have to lose?” when touting the drug combination of hydroxychloroquine or the related chloroquine with azithromycin as possible treatments for COVID-19.
April 23—Honduras adopts ivermectin country-wide.
May 1—Remdesivir is given EUA.
May 8—Peru adopts ivermectin country-wide.
May 21—United States and AstraZeneca form an expedited vaccine deal. The United States Department of Health and Human Services (HHS) says it expects the first doses to be available as early as October 2020; Phase III clinical studies are underway this summer.
June—The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends Veklury (remdesivir) for authorization.
June 1—Peru launches new protocol consisting of early outpatient treatment with individually prescribed combinations of paracetamol, azithromycin, hydroxychloroquine, and ivermectin.
June 15—Regeneron Pharmaceuticals shows that monoclonal antibody therapies can drive escape mutants of SARS-CoV-2 but that can be avoided by using antibody cocktails.
June 15—The EUA for hydroxychloroquine is rescinded except for patients in clinical trials.
June 18—WHO ends study into hydroxychloroquine as a treatment for COVID-19 announcing the data from their “Solidarity Trial” found the drug did not reduce mortality.
June 22—Dexamethasone, a steroid, is shown to be effective in patients with severe COVID-19.
June 30—Off-label treatment using ivermectin is reported in the Dominican Republic and doctors in Mexico, Ecuador, Bolivia, and Brazil share protocols. Sometime in June, country-wide ivermectin use begins in Bangladesh.
July—Health Canada authorizes use of remdesivir.
July 14—Moderna, which received a $500 million grant from the federal government to develop a COVID treatment, claims their experimental shot is safe and effective from data collected from phases I and II trials of three groups of 15 volunteers. Three patients in the highest-dose group have severe adverse reactions.
July—The city of Cali in Columbia adopts ivermectin based on positive results achieved in Guayaquil, Ecuador.
July 20—Japan’s Ministry of Health, Labour and Welfare (MHLW) approves Roche’s Ronapreve (casirivimab and imdevimab) monoclonal antibodies for the treatment of patients with mild to moderate COVID-19.
July 22—HHS and the US Department of Defense (DOD) announce vaccine distribution agreement with Pfizer and BioNTech for a December delivery of 100 million doses of their COVID-19 vaccine candidate, in a deal that could expand to 600 million doses if the vaccine receives approval or an EUA from the FDA, and if phase III clinical trial results confirm that the vaccine is safe and effective.
July 27—Moderna vaccine begins phase III trial, receiving $472 million from the Trump Administration, expanding the trial to 30,000 participants in the United States. The move brings the total investment made by the Biomedical Advanced Research and Development Authority to $955 million.
August 1—The state of Chiapas in Mexico adopts the use of ivermectin.
August 3—The United States pays Sanofi and GSK $2.1 billion for vaccines in an effort to “scale up” delivery of a COVID-19 vaccine.
August—Experts in Uttar Pradesh, India recommend ivermectin for specific patients.
August 11—Trump administration reaches $1.5 billion deal with Moderna despite still waiting on final data in the joint phase III trial.
August 22—Capital city of Lucknow in Uttar Pradesh, India adopts the use of ivermectin.
August 27—The NIH recommends ivermectin only for clinical trials, and advises against it as a treatment.
September 6—State of Alto Paraná in Paraguay adopts the use of ivermectin.
September 10—Italy reports of positive results of ivermectin, steroids, and tocilizumab for severe COVID-19.
September 14—Pfizer, BioNTech expand phase III trial from 30,000 participants to 44,000 to include adolescents as young as 16 years and patients with HIV, hepatitis C, and hepatitis B.
September 15—Argentina reports positive results in mortality outcomes using ivermectin, dexamethasone, enoxaparin, and aspirin.
September 21—Johnson & Johnson begins phase III vaccine trial of its experimental one-shot vaccine.
September 23—A new, more contagious strain of COVID-19 is discovered, known as the B.1.1.7 variant (Alpha).
September 30—The Dominican Republic adopts ivermectin use nation-wide.
October 10—States of Uttar Pradesh and Goa, India adopt early home treatment kits which include ivermectin.
October 12—The Ministry of Health of Peru retracts its ivermectin recommendation for hospitalized patients, creating a controversy, as hospitalized patients had been allowed treatments of hydroxychloroquine, azithromycin, and ivermectin since May with no harm. Distribution in many outpatient clinics continues.
October 31—Off-label use of ivermectin begins in some regions of the United States
November—WHO updates its guidance on COVID-19 against the use of remdesivir, citing lack of evidence to suggest that remdesivir affects the risk of mortality or of needing mechanical ventilation.
November 6—Argentina politician reports ivermectin protocols are being used in Argentina, Chile, Paraguay, Venezuela, Columbia, Costa Rica, Honduras, and other countries.
November 6—A plea in favor of an ivermectin permit in France is rejected before an administrative tribunal.
November 9—Pfizer releases data from its COVID-19 vaccine trial announcing that the shot was 90 percent effective.
November 18—Pfizer and BioNTech announce their mRNA vaccine is 95 percent effective for the treatment of COVID-19.
November 23—AstraZeneca reports their vaccine is 90 percent effective when administered as a half dose followed by a full dose at least a month later.
November 24—The Government of Canada signs an agreement for the supply of Eli Lilly/AbCelleara’s bamlanivimab monoclonal antibodies to Canada. The companies will supply Canada with 26,000 doses over a three-month period for $32.5 million.
November 30—Egypt adopts the use ivermectin nation-wide.
December—Japan secures a timely supply of Roche’s Ronapreve monoclonal antibodies.
December 10—University of California San Francisco Institute for Global Health Sciences hosts a digital forum and panel highlighting perspectives from global health experts on the opportunities and challenges associated with the use of monoclonal antibodies to treat COVID-19 in Africa.
December 11—FDA approves an EUA for the Pfizer vaccine.
December 17—The NIH updates prevention and prophylaxis guidelines for COVID-19, recommending against the use of any agents in either pre-exposure or post-exposure prophylaxis, except in clinical trials.
December 18—FDA approves an EUA for the Moderna vaccine.
December 18—Belize adopts ivermectin country-wide for serious cases.
December 21—New COVID-19 variants circle the UK and South Africa.
December 23—Macedonia adopts ivermectin nation-wide.
December 23—Merck & Co announces $356 million agreement with U.S. government to develop, manufacture, and distribute a biological therapeutic (MK-7110) upon FDA approval or EUA.
December 24—A South African newspaper reports import of ivermectin into South Africa is illegal.
2021
January 12—United States agrees to purchase 1.25 million doses of Regeneron’s REGEN-COV monoclonal antibodies for $2.625 billion, at $2,100 per dose.February 12—International consortium of 75 practitioners, researchers, specialists, and patient representatives representing 16 countries and most regions of the world met to present the results of a meta-analysis of 18 treatment randomized controlled trials and three prophylaxis random controlled trials. The panel finds evidence to recommend ivermectin for treatment in COVID-19.
February 25—EUA given to Regeneron REGEN-COV monoclonal antibodies.
April—FDA revokes Eli Lilly/AbCellera’s bamlanivimab monoclonal antibodies EUA due to clinical trial results that found adverse events and waning effectiveness, however bamlanivimab and etesevimab, administered together, remain available under EUA.
April 30—Canadian Ontario College of Physicians and Surgeons threaten to delicense any doctor who prescribes non-vaccine health strategies, including vitamin D.
May—EUA given to GSK and Vir Biotechnology’s sotrovimab monoclonal antibodies and GSK/Vir makes a $1 billion deal with the U.S. The company also has deals in place with Japan, Australia, and Canada.
May 5—The Central Drugs Standard Control Organisation (CDSCO) in India grants EUA to Roche (Genentech) and Regeneron REGEN-COV cairivimab/imdevimab monoclonal antibody cocktail in the country. Roche India partners with Cipla to market the drug in the country.
June 9—Hoffmann-La Roche’s casirivimab and imdevimab monoclonal antibody treatment is approved by Health Canada. Doctors in Hamilton, Ontario pilot province’s first monoclonal antibody therapy clinic for outpatients.
July 30—Health Canada authorizes GSK/Vir sotrovimab monoclonal antibodies.
July—The European Commission announces the purchase of 220,000 doses of GSK/Vir sotrovimab monoclonal antibodies.
August—UK approves its first monoclonal antibody treatment for COVID-19. Ronapreve, a combination of casirivimab and imdevimab, reduced the risk of hospital admission or death by 70 percent in high risk patients who had not been admitted to a hospital according to its phase III trial.
August 2—Researchers at Baylor Scott and White conduct trials on monoclonal antibodies, finding the antibodies can not only prevent severe illness, but also save lives. The study finds people with mild to moderate illness who get monoclonal antibody treatment early have very good outcomes in avoiding severe illness and death.
August 12—Florida expands monoclonal antibody access with new monoclonal antibody centers.
August—Texas Governor Greg Abbott receives Regeneron’s REGEN-COV monoclonal antibodies after testing positive for COVID-19.
August 23—FDA announces the first approval of a COVID-19 vaccine: the Pfizer-BioNTech Comirnaty vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
August 24—Fauci says during a White House briefing, “We recommend strongly that we utilize this (monoclonal antibodies) to its fullest,” calling monoclonal antibody treatment “effective” yet “underutilized” by most physicians treating the early cases of the virus.
August 31—An observational study published in The Lancet’s eClinicalMedicine journal finds a combination of two monoclonal antibody treatments keep COVID-19 patients out of the hospital when infected with mild to moderate disease.
September—Public Health and Medical Professionals for Transparency sue the FDA, claiming the agency denied its request to expedite the release of COVID-19 vaccine review documents via the Freedom of Information Act (FOIA).
September—Israel begins to widely administer Regeneron’s monoclonal antibody treatment. Almost half of the country’s eligible population rejects the introduction of monoclonal antibodies.
September 1—Podcaster Joe Rogan announces he took “the kitchen sink” to treat his COVID-19 infection, including monoclonal antibodies, Z-pac, ivermectin, and prednisone for COVID-19 and a media smear campaign to discredit ivermectin begins, describing ivermectin as a “horse dewormer.”
September 24—The WHO urges producers and governments to address the high cost of monoclonal antibodies and announces it is working with Unitaid to negotiate with pharmaceutical companies to lower prices for low- and middle-income countries.
October—More than 1.4 million doses of Regeneron’s REGEN-COV monoclonal antibodies are shipped to the United States.
November—The FDA proposes releasing approximately 500 pages per month of their Pfizer-BioNTech COVID-19 vaccine review documents per month due to the FOIA request by the Public Health and Medical Professionals for Transparency. This would fulfill the organization’s FOIA request in about 55 to 75 years.
November—The UK approves Merck’s antiviral molnupiravir for vulnerable patients recently diagnosed with COVID-19.
November 24—Omicron variant (B.1.1.529) is first reported to the WHO by South Africa.
December—The Centers for Disease Control (CDC) issues a recommendation that prioritizes the Moderna and Pfizer vaccines over the Johnson & Johnson vaccines due to reports of life-threatening adverse events.
December—The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) authorizes GSK/Vir’s sotrovimab monoclonal antibodies for high risk individuals older than 12 with mild to moderate COVID-19 symptoms based on clinical trial data that found sotrovimab reduced the risk of hospital admission and death by 79 percent in high-risk adults with symptomatic COVID-19.
December 6—Australia’s TGA grants provisional approval for the use of Celltrion’s Regikirona regdanvimab monoclonal antibodies.
December 7—Amid a report that the COVID-19 antibody treatment from Regeneron loses its effectiveness against the omicron variant, GSK and Vir Biotechnology announce that their monoclonal antibody drug is effective against Omicron’s full range of mutations. The study was performed in a lab, in vitro, against a synthesized version of the virus and showed that the treatment retained activity against all 37 mutations identified on Omicron’s spike protein.
December 20—FDA issues updated Health Care Provider Fact Sheet for Regeneron’s REGEN-COV monoclonal antibodies with specific information regarding expected activity against the Omicron variant.
2022
January 6—GSK in Canada signs agreement with the Government of Canada to supply 20,000 doses of GSK/Vir’s sotrovimab monoclonal antibody treatment for COVID-19.January 17—Health Canada authorizes use of Pfizer’s antiviral treatment Paxlovid.
January 19—The NIH publishes an updated version of the statement that the COVID 19 Treatment Guidelines Panel addressed the dominance of the Omicron variant in the U.S.
January 24—The FDA revises EUA for Eli Lilly’s bamlanivimab/etesevimab and Regeneron’s REGEN-COV monoclonal antibodies to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is not the Omicron variant. Providers may no longer administer these treatments within the United States. The State of Florida closes all monoclonal antibody state sites until further notice. The State of Florida makes a public statement that it disagrees “with the decision that blocks access to any available treatments in the absence of clinical evidence,” noting, “As stated in one of the preprint studies on the NIH website, “despite observing differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529 (Omicron).”
January 24—In response to the change, Florida Department of Health releases a statement that all monoclonal antibody state sites will be closed until further notice. The Communications office says, “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration.”
March 1—The FDA turns over more than 55,000 pages of 300,000 pages of documents related to its review of Pfizer-BioNTech’s COVID-19 vaccine following a loss in courts months earlier that forced it to make the information available to the public, marking the first of several releases mandated by a court in Texas. The FDA is currently processing approximately 400 other FOIA requests.
April 5 —The FDA revises the EUA for GSK/VIr’s sotrovimab monoclonal antibody treatment so that it is no longer authorized for use in the U.S. The State of Florida cannot use its currently contracted supply, and is left with only Eli Lilly/AbCellera’s bebtelovimab and AstraZenekca’s tixagevimab-cilgavimab EvuSheld for the immunocompromised.
April 13—Regeneron REGEN-COV monoclonal antibodies are still authorized in Europe.
May 5—FDA announces restricted use of the Johnson & Johnson COVID-19 vaccine to adults who cannot receive mRNA vaccines because of the risk of life-threatening thrombocytopenia syndrome, a rare form of blood clotting.
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