A Timeline of How Key COVID-19 Treatments Have Been Treated by Regulators

A Timeline of How Key COVID-19 Treatments Have Been Treated by Regulators
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Beth Giuffre
Updated:

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.

Here is a timeline noting when each COVID treatment came into and out of play with the help of an article on pandemic progression through 2020 from The American Journal of Managed Care, a timeline of Ivermectin-related Events in the COVID-19 pandemic by Mika Turkia in published in Research Gate, as well as a perspective published in Nature Reviews Immunology titled, “The first 12 months of COVID-19: a timeline of immunological insights.”
The list includes a timeline leading up to the methylprednisolone, ascorbic acid, thiamin, and heparin, melatonin, zinc, and vitamin D3 (MATH+) Protocol for the treatment of COVID-19 from the FLCCC website as well as dates and events from Regeneron and other industry websites involved in monoclonal antibody treatments.

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—More than 70 monoclonal antibodies are under development in the private and public sector, with multiple candidates in Phase II and III trials in high-income countries.

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 17—The American Heart Association, the American College of Cardiology, and the Heart Rhythm Society issue a warning on the safety and efficacy of hydroxychloroquine and chloroquine in patients with heart disease who contract the virus.

April 23—Honduras adopts ivermectin country-wide.

April 29—NIH trial announces non-peer reviewed, preliminary results for Gilead Science’s experimental drug remdesivir from a clinical trial that shows remdesivir is “better than a placebo” in treating COVID-19, despite the drug’s original failure to treat Ebola in Africa and a separate placebo-controlled multicenter study published April 29 when researchers found remdesivir offered no benefit to patients with COVID-19.

May 1—Remdesivir is given EUA.

May 6—The Chinese regime’s Central Guidance Team approves traditional Chinese medicine treatment of tai chi, baduanjin (medical qigong), and acupuncture therapy in Wuhan, China.

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 4—The Lancet and The New England Journal of Medicine (NEJM) retract COVID-19 studies on hydroxychloroquine on the same day after the authors said they could not vouch for the data used. A private database of medical records compiled by a little-known firm called Surgisphere was used in both studies.

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 20—NIH halts a clinical trial examining the safety and effectiveness of hydroxychloroquine as a treatment for COVID-19. The NIH indicates that the treatment does no harm, but also provides no benefit.

June 22—Dexamethasone, a steroid, is shown to be effective in patients with severe COVID-19.

June 29—Gilead sets price for remdesivir six vial hospital treatment at $3,120 for people covered with private insurance. Critics of the price point are quick to point out that taxpayers funded the COVID-19 remdesivir trial through the NIH.

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 21—AstraZeneca and CanSino Biologics, both with large financial support from UK and German governments and agencies, report “promising results” in vaccine trials. The interim results of AstraZeneca’s phase I and II trial of the recombinant adenovirus vaccine show that the vaccine was tolerated and increased immune responses against the virus in all participants who were evaluated. All trial participants were in good health, not in the high risk group for COVID, and none were given a true placebo. Instead they were randomly assigned either the AstraZeneca vaccine or the MenACWY (meningococcal conjugate) vaccine. Though researchers deemed “no serious adverse events,” some participants experienced moderate headaches, chills, fever, and muscle ache. One received a serious reaction from the MenACWY vaccine. In the Chinese company CanSino’s randomized, double-blind, placebo-controlled Phase II trial in Brazil, South Africa, and the United Kingdom, the experimental adenovirus vaccine data was reported safe, and “induced significant immune responses;” however, 72 percent of 503 participants experienced adverse reactions. Severe adverse reactions were reported by 10 percent of the participants.
Late July—Maddie de Garay, age 12, suffers serious injuries and seizures after her second shot in the Pfizer-BioNTech phase III trial.

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 23—Antibody levels drop after the first three months of COVID-19 infection according to findings from a research letter published in the New England Journal of Medicine. Researchers say antibody resistance would be depleted within a year, although experts note that the possibility of being infected again with the virus is very unlikely.
July 23—Researchers, including two inventors and patent holders of monoclonal antibodies, publish a Nature study of monoclonal antibodies as promising candidates for clinical development against SARS-CoV-2. They found the antibodies fall into two distinct groups, targeting different regions of the viral spike. “Thus, they say, the battle against COVID-19 could be waged on separate fronts, much like those against HIV and some forms of cancer.”

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 21—The influential journal Science publishes a study by Regeneron authors and stockholders, HHS, and others, which find Regeneron’s monoclonal antibodies correspond to potent and diverse antiviral antibodies. Human trials of monoclonal antibodies are underway.

August 22—Capital city of Lucknow in Uttar Pradesh, India adopts the use of ivermectin.

August 23—The FDA issues an EUA, for convalescent plasma from recovered patients as a therapy to fight COVID-19. There is ongoing debate about the treatment. Meanwhile, White House Press Secretary Kayleigh McEnany claims it is a therapeutic breakthrough.
August 24—Remdesivir’s clinical benefits questioned when a global, multicenter study published in JAMA finds that the antiviral drug remdesivir had little effect on patients hospitalized with COVID-19. The findings indicate there were no significant differences in duration of supplemental oxygen or hospitalization between the intervention group given remdesivir and the control group given standard care.

August 27—The NIH recommends ivermectin only for clinical trials, and advises against it as a treatment.

September 1—The United States opts out of COVAX, the World Health Organization’s (WHO) global COVID-19 vaccine effort to develop, make, and distribute COVID-19 vaccine.
September 3—Three studies report that inexpensive steroids are the most effective treatment to date for serious COVID-19. Results from the studies find that the use of systemic steroids can reduce the risk of death by one-third in individuals hospitalized with COVID-19 compared with usual care or placebo.
September 3—Sanofi and GSK begin a clinical trial of their protein-based vaccine.

September 6—State of Alto Paraná in Paraguay adopts the use of ivermectin.

September 8—AstraZeneca halts phase III vaccine trial for a safety data review following an “unknown adverse reaction” in a UK participant.

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 14—After AstraZeneca put its phase III trial on hold, the NIH announces it is launching an investigation into the adverse reactions revealed as spinal cord damage.

September 15—Argentina reports positive results in mortality outcomes using ivermectin, dexamethasone, enoxaparin, and aspirin.

September 16—Trump Administration releases vaccine distribution plan devised by HHS and the DOD that aims to make a COVID-19 vaccine free for all Americans, with the vaccine to be rolled out in January 2021.

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 29—Regeneron announces positive results for monoclonal antibody treatment, a mixture of two monoclonal antibodies.The results from its ongoing phase I/II/III trials found the treatment was linked to quicker recovery, reduced viral load, and the need for fewer medical visits.

September 30—The Dominican Republic adopts ivermectin use nation-wide.

October 2—President Trump announces that he and First Lady Melania Trump have tested positive for COVID-19. After experiencing mild symptoms of the disease, Trump was taken to Walter Reed National Military Medical Center, “out of an abundance of caution,” said Press Secretary Kayleigh McEnany in a statement.
October 5—After three days, President Trump is discharged from the hospital and transported back to the White House, where he would continue to receive treatment for COVID-19 and be monitored. White House physician Sean Conley, DO, said the president’s fever is gone and that his oxygen levels are normal. During his time at the hospital, the President’s treatment consisted of Regeneron’s monoclonal antibodies, remdesivir, and dexamethasone (a steroid). The President also received several of the medicines in the MATH+ treatment protocol, including vitamins and zinc, however the media focuses only on the quick recovery with monoclonal antibodies and remdesivir.
October 8—Eli Lilly and the Bill & Melinda Gates Foundation agree to facilitate supply of monoclonal antibodies for low-and middle-income countries as part of the Therapeutics Accelerator initiative.
October 9—The Trump administration signs a $486 million agreement with AstraZeneca (which produces Evusheld) to develop an antibody treatment for COVID-19, which would call for HHS and the DOD to work with the company to roll out late-stage development and large-scale manufacturing a combination of two monoclonal antibodies with potential to treat or prevent the disease.

October 10—States of Uttar Pradesh and Goa, India adopt early home treatment kits which include ivermectin.

October 12—Johnson & Johnson halts recruitment for its phase III trial for its COVID-19 vaccine after a patient’s “unexplained illness.” It later resumes the study of its one-dose regimen.

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 22—FDA approves remdesivir as the first FDA-approved drug to treat COVID-19 after three randomized trials found it to decreased the length of hospital stays and reduced the likelihood that patients would require oxygen. None of the trials showed reduced risk of mortality, however, and a WHO-backed study found that the drug had “little to no effect” on hospitalized patients. October 23—AstraZeneca and Johnson & Johnson announce restart of their COVID-19 vaccine trials.

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 9—FDA issues EUA for Eli Lillys’ bamlanivimab, a monoclonal antibody treatment that mimics the immune system’s response to infection with SARS-CoV-2 and appears to protect high-risk patients with COVID-19 from progressing to more severe forms of the disease. Clinical trials showed reductions in COVID-19–related hospitalizations or emergency visits in these patients within 28 days of treatment compared with placebo.
November 16 —Moderna announces its experimental mRNA vaccine reduces the risk of COVID-19 infection by 94.5 percent in participants who received it.

November 18—Pfizer and BioNTech announce their mRNA vaccine is 95 percent effective for the treatment of COVID-19.

November—EUA is revised to clarify Regeneron’s REGEN-COV monoclonal antibodies should not be used for people who are hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19.
November 20—Pfizer and BioNTech submit their COVID-19 vaccine to the FDA for an EUA.
November 20—Canada gives interim authorization for the use of Eli Lilly/AbCellara’s bamlanivimab monoclonal antibodies for adults and pediatric patients 12 years and older.
November 21—EUA is issued for Regeneron’s REGEN-COV monoclonal antibody cocktail (cairivimab and imdevimab) in the U.S. after a randomized, double-blind, placebo-controlled clinical trial of 799 people found the treatment significantly reduces virus levels within days.

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 10—An FDA advisory panel endorses the Pfizer and BioNTech vaccine. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) decides the benefits of the vaccine outweigh the risks for those ages 16 and older.

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 17—The FDA advisory panel meets and agrees that the Moderna vaccine will benefit individuals 18 years and older.

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—The Trump administration announces it will buy an additional 100 million doses of the Pfizer vaccine.

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.

December 28—Novavax begins a phase III clinical trial for its investigational COVID-19 vaccine in Mexico and the United States.
December 30—UK Approves EUA for the AstraZeneca vaccine for individuals 18 years and older.

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.
January 24—Germany purchases 200,000 doses of Regeneron’s REGEN-COV monoclonal antibodies for €400 million ($490 million) at €2,000 ($2450)per dose.
February 5—JAMA publishes the paper, “Monoclonal Antibodies for COVID-19” that mentions some mutations, such as the new UK variant “may cause changes in the spike protein that could interfere with the effectiveness of currently available monoclonal antibodies.
February 11—NIH issues neutral recommendation on ivermectin, where they found, “there was insufficient evidence to recommend for or against ivermectin in COVID-19.”

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 28—Health Canada issues warning on bamlanivimab monoclonal antibodies about the “potential risk of treatment failure” identified through “global surveillance.”

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.

May 14—The Government of India Ministry of Ayush releases COVID-19 prevention and treatment guidelines for Ayurveda, Yoga, Naturopathy, Unani, Siddha, and homeopathy practitioners which include herbs such as curcumin, quinine, and echinacea as well as lifestyle suggestions such as getting adequate sleep. A global perspective article (Elsevier, March 2021) finds complementary and alternative medicine (CAM) had been used for COVID in more than 25 percent of patients in India, as well as up to 80 percent of the population of Pakistan, as well as Bangladesh, Nepal, Sri Lanka, Afghanistan, Bhutan, and Maldives. A survey from the same paper found 22 percent of Saudi Arabians used CAM such as chamomile and garlic to prevent COVID-19, as well as 80 percent of the African populations, according to the WHO, and communities in South America, Europe, and North America.
May 25—Roche India and Cipla announce Regeneron’s REGEN-COV monoclonal antibodies will be available in India for 59,750 rupees per dose (about $787 US).

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.

June 16—UK RECOVERY trial shows Regeneron’s REGEN-COV monoclonal antibodies reduce mortality by 20 percent in people who don’t produce antibodies themselves.
July 9—Dr. Rachel Levine, HHS assistant secretary becomes the American spokesperson for monoclonal antibodies, airing an advertisement for the treatment.

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 3—In September of 2021, The Highwire featured the piece, “Is Monoclonal Antibody Treatment Saving Lives?” featuring a doctor who had seen monoclonal antibodies work well in his clinical practice and calls them “a game changer.”
September 14—The United States agrees to purchase an additional 1.4 million doses of Regeneron’s REGEN-COV monoclonal antibodies, totaling $2.94 billion.
September 22—Dr. Joseph Ladapo, Florida State Surgeon General, issues a Standing Order authorizing monoclonal antibodies: Regeneron’s REGEN-COV (casirivimab and imdevimab), Eli Lilly/AbCella’s bamlanivimab, and GSK/Vir’s sotrovimab for the treatment of COVID-19 in accordance with the EUA, allowing patients to receive the treatment without a prescription or referral if administered by an eligible health care provider. Treatments are available at no cost to patients.

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 15—Roche Products Ronapreve monoclonal antibodies (casirivimab and imdevimab) is granted provisional approval by Australia’s FDA, the Therapeutic Goods Administration TGA, for adults and those aged 12 and older, and for those who cannot medically tolerate vaccines, making it the third COVID-19 treatment to receive regulatory approval in Australia. According to Reneneron’s website, Regeneron and Roche have been collaborating to increase the global supply of REGEN-COV.

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 12—Roche’s Ronapreve (casirivimab/imdevimab) and Regkinora (regdanvimab) monoclonal antibodies become authorized in the EU after a recommendation from the The European Medicines Agency’s Committee for Medicinal Products for Human Use on November 8.

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 7–14—Four non-peer reviewed preprints from December 7–14, written by international researchers supported by the Chan Zuckerberg Initiative assert the Omicron variant may be totally or partially resistant to most currently available monoclonal antibody treatments.

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 8—FDA issues EUA for AstraZeneca’s Evusheld monoclonal antibodies (tixagevimab co packaged with cilgavimab) for the prevention of COVID-19 in certain adults and pediatric individuals aged 12 and older who are immunocompromised or have had a history of severe adverse reactions to a COVID-19 vaccine.

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.

December 22—FDA issues EUA for Pfizer’s Paxlovid (oral antiviral) for the prescribed treatment of COVID-19.
December 23—FDA issues EUA for Merck’s molnupiravir (oral antiviral) for the treatment of COVID-19 in certain adults.

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 21—The FDA expands the use of remdesivir to outpatients and adolescents.

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.

April 26—Denmark suspends its national COVID-19 vaccine campaign after health officials say the pandemic is under control, becoming the first country in the world to do so.

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.

Beth Giuffre
Beth Giuffre
Author
Beth Giuffre is a mosaic artist and frequent contributor to the Epoch Times. When the youngest of her three sons began having seizures, she began researching the root cause of intractable epilepsy, and discovered endless approaches to healing for those who are willing and open to alternatives.
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