Interleukin-6(Pfizer Global Manufacturing China)

The Pfizer-BioNTech vaccine (now Comirnaty®) was fully approved by the U.S. Food and Drug Administration (FDA) on August 23 and boosters of this shot are now available to the most vulnerable Americans. This is an update of an article originally published on November 24, 2020, and a lot has happened! A novel virus means clinical research is playing out in real-time. The Pfizer - BioNTech vaccine (now Comirnaty®) was fully approved by the U.S. Food and Drug Administration (FDA) on August 23, boosters of this shot are now available to the most vulnerable Americans, and hope is on the horizon that hospitalization and death can largely be averted by a pill. But first, an update on the variant situation. A Note on Variants: In an effort to make it easier for the public and media to discuss variants, the World Health Organization convened experts from various organizations and internal divisions to “consider easy-to-pronounce and non-stigmatizing labels.” Which is why there are now Greek Alphabet names for the various variants, at least those that WHO has declared Variants of Concern (VOC) and Variants of Interest (VOI). Currently, the Delta variant is the only variant classified as a VOC in the United States, and there are no currently recognized VOIs. Wuhan or Wildtype The first strain to be identified that originated in the city of Wuhan, China. Delta (India) This is the variant still causing havoc across the U.S and much of the world. Dubbed a “double mutant” variant, Delta (B.1.617) has two key mutations observed in other coronavirus variants. The variant was actually first sequenced in a global database of COVID-19 variants in October 2020, but went largely unnoticed. The B.1.617 strain carries features from two lineages, the California variants (B.1.427 and B.1.429) and the ones in South Africa (B.1.351) and Brazil (P.1). The variant’s two prominent mutations include a position 452 of the spike protein and the second at 484. It is believed to be about 60% more contagious than the Alpha variant. As of September 25, the CDC estimated that Delta is responsible for more than 99% of all cases in the U.S. According to recent studies , the Pfizer-BioNTech vaccine is holding up against the Delta variant. AY.4.2 (Delta-Plus). A subvariant of the Delta variant, as of October 21, 2021, it has been observed in the UK, Denmark and the U.S. Very little is known about its transmissibility, although there is speculation it might be 10% more transmissible than Delta. Past Variants of Concern Alpha (UK) Dubbed B.1.1.7, the UK variant was first identified in the fall of 2020. It spreads more easily and quickly than other variants, according to the CDC, and is potentially 30% more lethal than the wildtype version, although that is still being investigated. It was first detected in the U.S. at the end of December 2020. Beta (South Africa) Originally B.1.351, Beta emerged independently of B.1.1.7 (UK) and was first detected in South Africa in early October 2020. It shares some of the same mutations as the UK strain. Cases in the U.S. were first reported at the end of January 2021. Current evidence suggests it does respond to vaccines, but can evade antibodies generated by the immune system against the original SARS-CoV-2 virus due to its E484K mutation. Gamma (Brazil) The Brazilian, originally P.1, was first identified in people traveling from Brazil during routine testing in Japan, in early January. It appears to have a group of additional mutations (including E484K and N501Y) that affect its ability to be recognized by antibodies, according to the CDC. It was first observed in the U.S. at the end of January 2021. Iota (New York) This variant first appeared in New York City and then sporadically in the northeast. It was named B.1.526. It also contains the E484K mutation, which has been observed in at least 59 different lineages of coronavirus. This means it is evolving independently around the world in what is called convergent evolution. Mu Mu, or B.1.621, in September 2021 was categorized by the WHO as a “variant of interest.” It appeared to originate in January 2021, in Columbia, but does not appear to have spread much around the world. California This variant was called B.1.427/B.1.429 and appeared different than the UK variant. One of the mutations, called L452R, affects the virus’s spike protein, which may allow it to attach itself more efficiently to cells, making it more infectious. Like with the New York variant, the data had not been peer-reviewed at the time of publication. However, it appeared to be associated with severity of disease and increased risk of high oxygen requirement. In particular, the virus appeared to be prevalent in the San Francisco area. A Note on Pricing The prices listed, for the most part, are the prices that were known at the time this article was first published. Because of multiple contracts by various governments and how they are being reimbursed, there is significant variability in actual prices. Some have significantly dropped since the original publication and appear to be changing regularly. Also, there are considerable variations in pricing from country to country. If you find any variations or inaccuracies, please let us know. A Note on the Vaccine Market and Sales Getting a handle on the COVID-19 vaccine market and sales is definitely a moving target, with governments subsidizing manufacturing and distribution, and prices varying from country to country. According to Morningstar, the 2021 vaccine market will max out at $67 billion, and 2022 will see this drop to $61 billion. Morningstar noted on May 3, 2021 that the Pfizer-BioNTech and Moderna COVID-19 vaccines account for more than 60% of the total COVID-19 market estimate in 2021 and 2022. More recently, InsightAce Analytic projected that the global COVID-19 therapeutics market size would reach $25.6 Billion in 2030. The numbers by research firm vary greatly, with many projecting a drop-off in 2023 as more people, particularly in developing nations, become vaccinated. The 10 best-selling COVID-19 vaccines and drugs in the first half of 2021 are: 1 . Pfizer-BioNTech COVID-19 vaccine (Comirnaty®): Worldwide sales were $19.927 billion . GlobalData Healthcare projects that Comirnaty will bring in $100 billion in sales between 2020 to 2027, with a large portion of the revenue driven by the 2021-2024 time period. 2 . Moderna COVID-19 vaccine: Worldwide sales equaled $5.93 billion. U.S. Sales amounted to 58% of the pie at $3.451 billion. 3 . Regeneron Pharmaceuticals ’ casirivimab and imdevimab (REGEN-COV): Regeneron’s antibody cocktail reported $4.156 billion in global revenue and $2.853 billion in U.S. sales alone. 4 . Gilead Sciences ’ remdesivir (Veklury): Global sales totaled $2.285 billion for the antiviral drug. U.S. sales accounted for 54% at $1.236 billion. 5. Roche and Genentech ’s Actemra ® / RoActemra® (toclizumab): The Interleukin-6 (IL-6) receptor antagonist brought in $1.789 billion globally and $751 million in U.S. sales. 6 . AstraZeneca -Oxford COVID-19 vaccine: Worldwide, the viral vector shot brought in $1.135 billion in global sales. This vaccine is not currently approved in the U.S. 7 . Eli Lilly bamlanivimab and etesevimab: The antibody cocktail brought in $959.1 million in worldwide sales. U.S. sales were $734 million. 8 . Eli Lilly ’s Olumiant (baricitinib): Lilly’s Janus kinase (JAK) inhibitor earned $402.2 million worldwide, with just $42.5 million coming from U.S. sales. 9. Johnson & Johnson ( Janssen ) Vaccine: The single-shot vaccine brought in $264 million globally, with $151 million of the revenue coming from the U.S. J&J reported $502 million in sales of its COVID-19 vaccine in the third quarter of 2021. 10. Celltrion Healthcare ’s antiviral Regkirona® (regdanvimab; CT-P59): Netted global sales of $37.6 million. Vaccine Details Pfizer-BioNTech ( Comirnaty®) The Pfizer-BioNTech COVID-19 vaccine was sent to the FDA for possible Emergency Use Authorization (EUA) on Friday, November 20 and authorized on December 11. It received full approval on August 23, 2021 and became known by its brand name, Comirnaty. It is an mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. In Phase III trials, it demonstrated 95% efficacy. The Pfizer-BioNTech vaccine requires storage at about -94 degrees F, which requires specialized freezers. Now authorized in the U.S. for adolescents 12 to 15 years of age. The Pfizer-BioNTech and Moderna COVID-19 vaccines have been associated with very rare cases of myocarditis (heart inflammation) in some young adults and teenagers, although the association has been called “likely.” On September 23, the FDA authorized a booster shot of the Pfizer-BioNTech vaccine for people over the age of 65, individuals at high risk for severe disease and front-line healthcare workers six months after they received their second dose. The following day, the CDC added a group, recommending boosters for people between the ages of 18 and 64 who are at increased risk of COVID-19 due to their work or living situation. The FDA has also authorized mixing-and-matching vaccines as boosters. Type: mRNA Doses: 2, 21 Days Apart EUA Date: December 11, 2020 Full Approval Date : August 23, 2021. Price: $19.50 per dose for first 100 million doses. Projections : At Pfizer’s second-quarter earnings report, it forecasted 2021 sales of the COVID-19 vaccine to be $33.5 billion. Efficacy: About 95%. Apparently 100% at preventing hospitalization and death. Variants: Lab data suggest “quite effective” against the Alpha variant as well as the Beta and Gamma variants. Also, data suggests it is effective against hospitalization in cases caused by the Delta variant but more data is needed. Moderna On November 16, 2020, Moderna issued a preliminary data readout out of its COVID-19 vaccine, suggesting an efficacy rate of 94.5%. It was authorized by the FDA on December 19. Like the Pfizer-BioNTech vaccine, it is an mRNA vaccine. Unlike that shot, however, the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F. In May 2021, Moderna reported that a Phase II/III trial of 3,732 children ages 12 to 17 in the U.S. demonstrated its vaccine produced an immune response equivalent to earlier findings in adults. Data also suggested the vaccine was 93% effective after one dose at preventing mild COVID-19 cases. It was generally well-tolerated. Moderna filed for an EUA for the vaccine in adolescents on June 10, 2021. In October 2021, the FDA authorized the Moderna vaccine for people who are immunosuppressed, people over the age of 65, people at high risk of severe disease, front-line healthcare workers, and for people between the ages of 18 and 64 who are at increased risk of COVID-19 due to their work or living situation. The FDA has also authorized mixing-and-matching vaccines as boosters. Type: mRNA Doses: 2, 28 Days Apart EUA Date: December 18, 2020 Price: $25-$37 per dose Projections : At its second-quarter earnings report, Moderna projected $19.2 billion in COVID-19 vaccine sales for 2021. Efficacy: About 95%. Apparently 100% at preventing hospitalization and death. Variants: Lab data suggest “quite effective” against the Alpha variant as well as the Beta and Gamma variants. Also, data suggests it is effective against hospitalization in cases caused by the Delta variant but more data is needed. Johnson & Johnson Projections : On February 27, the FDA approved Johnson & Johnson (Janssen’s) COVID-19 vaccine under EUA. Whereas the Pfizer-BioNTech, Moderna and AstraZeneca vaccines all require two doses about 28 days apart, the J&J vaccine requires only a single dose. The Phase III ENSEMBLE trial demonstrated the single-shot vaccine is 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination. However, it demonstrated 100% efficacy at preventing severe disease after day 49. The vaccine uses the company’s AdVac technology platform, which it used to develop its approved Ebola vaccine and its Zika, RSV and HIV investigational vaccine candidates. It revolves around the use of an inactivated common cold virus, similar to what the AstraZeneca-University of Oxford program utilizes. In April 2021, the CDC and FDA recommended a pause on distribution of the vaccine. Six cases of a “rare and severe” type of blood clot had been identified. The clots observed with the J&J vaccine are cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets, called thrombocytopenia. All six of the cases were in women between the ages of 18 and 48 and occurred six to 13 days after receiving the single-dose vaccine. These six cases were extremely rare among the more than seven million doses administered. The FDA and CDC had placed a pause on the J&J vaccine on April 13 over six reported cases of a “rare and severe” blood clot known as cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia). On April 23, they lifted the restrictions, saying that the benefits outweighed the risks. In July, the FDA planned a new warning for the J&J vaccine over a rare but serious side effect, Guillain-Barré syndrome (GBS). Guillain-Barré syndrome, which has been linked to other vaccines in the past, is a rare neurological disorder where the immune system attacks part of the peripheral nervous system. Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the CDC. They appear about two weeks after vaccination and primarily in men, most 50 years of age and older. In October 2021, the FDA authorized the J&J vaccine for people who are immunosuppressed, people over the age of 65, people at high risk of severe disease, front-line healthcare workers, and for people between the ages of 18 and 64 who are at increased risk of COVID-19 due to their work or living situation. The FDA has also authorized mixing-and-matching vaccines as boosters. Type: Adenovirus-based Doses: 1 Authorized Under EUA. Price: $10 per dose Projections : At its half-year earnings report 2021, J&J estimated full-year vaccine sales of $2.5 billion. Efficacy: In J&J’s global clinical trial, the vaccine demonstrated 66% efficacy at preventing symptomatic COVID-19 infections. In the U.S. it was slightly higher at 72%. It appears to be 100% effective at preventing hospitalizations and death. Variants: Based on clinical studies in Africa, UK and Latin America, there is evidence the vaccine is effective against the variants, although less so against the Beta and Gamma strains. The table below shows the comparison of EUA approved vaccines in the U.S. COMPANY PFIZER/BIONTECH MODERNA J&J/JANSSEN Research Name BNT162b2 mRNA-1273 Ad26.CoV2.S Name Comirnaty Spikevax Janssen COVID-19 vaccine Type mRNA mRNA viral vector EUA Approved 12/11/2020 12/18/2020 2/27/2021 FDA Fully Approved 8/23/2021 (for people ages 16 and older) No, but been submitted No, be submitted later this year Authorized Ages 5 and older 18 and older Delayed decision for children 12-17 years old (could be Jan. 2022) 18 and older Authorized Ages for Booster Yes, for all (ages 16 and up) Yes Yes # of Doses 2 (21 days apart) 2 (28 days apart) 1 Efficacy* 91.3% to 95% at preventing symptomatic disease; 100% at preventing severe disease as defined by CDC, 95.3% as defined by FDA 95% symptomatic, 96.3% to 100% at preventing hospitalization and death 28 days after inoculation: 85.4% for severe disease and 93.1% against hospitalization Efficacy Against Delta Variant* Early research suggests 88% efficacy at preventing symptomatic COVID-19 virus & 96% efficacy against hospitalization Early research suggests 72% efficacy at preventing symptomatic COVID-19 virus According to J&J research, 85% effective at preventing severe disease, up to 95% for preventing death Common Side Effects At site of injection: Pain, swelling, redness Other: Tiredness, headache, muscle pain, chills, fever, nausea, swollen lymph nodes At site of injection: pain, swelling, redness Other: tiredness, headache, muscle pain, chills, fever, nausea, swollen lymph nodes Injection site pain, headache, fatigue, myalgia, nausea, swollen lymph nodes Rare Side Effects Allergic reaction, myocarditis, pericarditis, swollen lymph nodes, decreased appetite, diarrhea, vomiting, fainting due to shot Allergic reaction, myocarditis & pericarditis in adolescents and young adults (~12.6 cases per million 2nd dose administered) Anaphylaxis and severe allergic reaction, blood clots, Thrombosis with Thrombocytopenia syndrome usually occurring in women younger than 50, Guillain-Barré syndrome, capillary leak syndrome, fainting due to shot Price $19.50 per dose $25-$37 per dose $10 per dose Projected Sales $33.5 billion for 2021 $19.2 billion for 2021 $2.5 billion for 2021 # of Fully Vaccinated in U.S. (Source: CDC data as of 12/13/21) 113,046,986 72,677,133 16,117,973 * Dozens of studies have been conducted on the efficacy of the vaccines, within structured clinical trials, real-world studies, and laboratory assays. The stated efficacy values generally reflect a consensus range, which can vary depending on study structure, patient population and most common circulating viral variant at the time of the study. AstraZeneca-University of Oxford On November 23, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%. The vaccine was effective at preventing COVID-19, with no hospitalizations or severe cases in people receiving it. There were a total of 131 COVID-19 positive cases in the interim analysis group. One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when two full doses were given at least one month apart. The combined analysis showed average efficacy of 70%. The AstraZeneca vaccine can be stored, transported and handled at normal refrigerated conditions, about 36-46 degrees F, for at least six months and administered within existing healthcare settings. On March 25, 2021, AstraZeneca released primary analysis showing that the vaccine demonstrated 76% efficacy against symptomatic COVID-19, 100% efficacy against severe or critical disease and hospitalizations, and 85% efficacy against symptomatic COVID-19 in people 65 years and older. The AstraZeneca and University of Oxford’s vaccine uses technology from an Oxford spinout company, Vaccitech . It deploys a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees. It contains the genetic materials of the spike protein. After vaccination, the cells produce the spike protein, stimulating the immune system to attack the SARS-CoV-2 virus. The COVID-19 vaccine developed by AstraZeneca and the University of Oxford has been linked to blood clots. More than a dozen European countries have halted the distribution of the AstraZeneca-Oxford vaccine as a result. In May in England, it was recommended that people under the age of 40 should receive a different vaccine due to blood clots. There was a report of an arterial stroke in the UK published online in Journal of Neurology Neurosurgery & Psychiatry in late May. The most recent data, from July 2021, indicates that the risks of clotting combined with low blood platelets (vaccine-induced immune thrombotic thrombocytopenia, or VITT) are about 1 to 2 per 100,000 vaccinations, in the UK and Europe. Type: Adenovirus-based Doses: 2, 28 Days Apart Likely FDA Authorization Date: Authorized in Europe on January 12, 2021, and other countries, but unlikely in the U.S. The delay is due to AstraZeneca’s decision to request full approval in the U.S. As of October 21, 2021, AstraZeneca-Oxford have not filed in the U.S. for EUA. Price: $2.15 (U.S.) in the EU; $3-4 (U.S.) in the UK and U.S.; $5.25 (U.S.) in South Africa During the first half of 2021, AstraZeneca and the University of Oxford reported $1.135 billion in global sales. Analyst projections suggest annual sales will be $1.5 billion to $2.5 billion. Efficacy: Currently about 70% overall. Variants: At least one study finds it has little effect against the Beta variant, but appears effective against the Alpha and Gamma variants. Russia’s Sputnik V Vaccine Around November 11, 2020, Russia’s National Research Center for Epidemiology and Microbiology claimed Sputnik V had an efficacy rate of 92% after the second dose. The vaccine was authorized for use in Russia in August 2020 before even the beginning of a Phase III trial. The updated efficacy evaluation was based on a first interim analysis 21 days after the first injection during the ongoing Phase III study. On November 24, the organization claimed 95% efficacy based on new preliminary data. On December 14, 2020, they reported efficacy of 91.4%. It also offered to share one of its two human adenoviral vectors with AstraZeneca to increase the efficacy of the AstraZeneca vaccine. Russia’s Gamaleya research institute appears to be focused on potentially marketing their vaccine worldwide. Even the name of the vaccine has emphasized the idea of a race. The organization has indicated a dose of the vaccine will cost no more than $10, about half the cost of the Pfizer vaccine. The organization has also predicted it could produce 1 billion doses in the next year. On February 2, 2021, The Lancet published Phase III data demonstrating a 91.6% efficacy against the original strain of the virus. This vaccine, even into mid-July 2021, remains controversial . It is being distributed in 39 countries and is expected to be distributed in 27 more. However, inconsistent clinical trial data has scientists questioning the analyses and wondering if it has been manipulated. It was originally authorized in Russia in August 2020 after being tested on only 38 people. The Gamaleya Research Institute published results showing 95% efficacy in The Lancet but did not include raw data. In mid-May, a group of international scientists highlighted concerns over patterns in The Lancet data consistent with data manipulation. Even though some studies have been published about the Sputnik V vaccine, Reuters noted as of July 13 that the vaccine’s Russian developers have repeatedly failed to provide the necessary data for regulators in Europe to assess it appropriately. As of October 21, 2021, the Europe has indicated they do not expect authorization until early 2022 due to missing data. Type: Adenovirus-based Doses: 2 Likely EUA Date: Not applicable in the U.S. Price: $10 per dose Efficacy: 91.4% Variants: Unknown. Clinical trial data was largely conducted in Russia prior to the emergence of major variants. Sinovac Biotech On January 13, 2021, China-based Sinovac Biotech reported that its COVID-19 vaccine had a 50.38% efficacy in late-stage clinical trials in Brazil. The company’s clinical trials are demonstrating dramatically varying efficacy rates . In Indonesia, a local trial demonstrated an efficacy rate of 65%, but the trial had only 1,620 participants. Turkey reported an efficacy rate of 91.25% in December 2020. Another trial in Brazil run by a local partner, Butantan Institute, reported a 78% efficacy rate in mild cases while 100% against severe and moderate infections. It is an inactivated vaccine that uses inactivated SARS-CoV-2 viruses. In May 2021, WHO requested more data from the company regarding the safety of the shot and its manufacturing process. They want to determine if it is compliant with WHO standards and expect to make a decision in June. As of mid-July 2021, WHO studies showed the Sinovac vaccine “prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population” for adults aged 18 and older. However, few adults over the age of 60 were enrolled in the trials, so efficacy could not be evaluated for that age group. Type: Inactivated SARS-CoV-2 virus Doses: 2 Likely EUA Date: Not applicable in the U.S. Price: $60 per dose in China ($29.75 per dose) Efficacy: 50.38% to 91.25%, depending on the clinical trial Variants: Unknown, although a study in Brazil demonstrated 50.4% efficacy at preventing symptomatic infections. Novavax On January 28, 2021, Novavax announced that its protein-based COVID-19 vaccine, NVX-CoV2373, hit the primary endpoint with an efficacy of 89.3% in its Phase III trial in the UK. It also has amassed data from the South Africa Phase IIb trial and several Phase I, II and III trials. It has demonstrated high clinical efficacy against the Alpha and Beta variants as well. The vaccine contains a full-length, prefusion spike protein made using the company’s recombinant nanoparticle technology and its proprietary saponin-based Matrix-M adjuvant. It is stable at 2 to 8 degrees C and shipped in a ready-to-use liquid formulation. With the U.S. largely covered, Novavax is now expected to delay its filing with the FDA until the fourth quarter of 2021. On September 23, Novavax, along with partner Serum Institute of India, filed with WHO for Emergency Use Listing. In October 2021, there were reports that the company was having problems getting its COVID-19 vaccine to the finish line due to manufacturing issues. In addition to an expected submission to the U.S. Food and Drug Administration (FDA) before the end of 2021, it has ongoing rolling submissions in the UK, Europe, Canada, Australia and New Zealand which is expects to wrap in late October 2021/early November 2021, and has already made submissions in Indian, Indonesia and The Philippines in addition to an Emergency Use Listing (EUL) with the World Health Organization (WHO). Type: Protein-based vaccine Doses: 2 Likely EUA Date: Expected to file Q4, 2021. Price: $16 in the US Efficacy: 90.4% Variants: Effective against Alpha and Beta variants. CanSino Biologics CanSino Biologics’ vaccine was co-developed with the Chinese military. It has an efficacy rate of 65.7% at preventing symptomatic cases. This is based on a multi-country analysis first posted on Twitter by Faisal Sultan, Pakistan’s health adviser, on February 8, 2021. The Phase III trial includes 30,000 participants and demonstrated 90.98% efficacy in preventing severe disease. It only requires a single shot. CanSino has agreed to supply 35 million doses to Mexico and is in talks with Malaysia for 3.5 million shots. Pakistan is running one of the largest trials and has contracted for 20 million shots. It is also working with the WHO for approval for the vaccine through the Covax program. It is also planning a trial with Russia to determine if swapping the second dose of Russia’s Sputnik V vaccine with Can Sino would produce the same or better protection. In a trial in February, the vaccine demonstrated efficacy of 65.7% in preventing symptomatic cases. But in April, the company noted that its efficacy rate seemed to drop over time, but should have a rate of 50% or more five to six months after inoculation. According to a study out of Mexico’s National Institute of Medical Sciences and Nutrition, the CanSino vaccine only offers protection for about six months. They also believe that a second dose of the vaccine would likely be necessary. Type: Viral vector, loading an antigen from the SARS-CoV-2 virus onto an adenovirus. Doses: 1 Price: Unknown Likely EUA Date: Not applicable in the U.S. Efficacy: 65.7% at preventing symptomatic cases; 90.98% efficacy in preventing severe disease. Variants: Unknown Bharat Biotech On April 22, 2021, India’s Bharat Biotech reported interim data from the Phase III trial of its COVID-19 vaccine COVAXIN, which demonstrated a 100% efficacy against severe infection. The vaccine was developed with seed strains from the Indian Council of Medical Research’s (ICMR) National Institute of Virology. It is a highly purified and inactivated vaccine. A second interim analysis suggested a 78% efficacy against mild, moderate and severe disease, and 70% efficacy against asymptomatic disease. It does not require sub-zero storage or reconstitution requirement and is ready to use liquid in multi-dose vials. It is stable at 2-8 degrees C. As of July 9, the company reportedly submitted all documents required for Emergency Use Listing (EUL) to WHO. India’s Bharat Biotech announced in October 2021, that it had delivered one billion doses of its COVID-19 vaccine, Covaxin, in only nine months. In the same month, India’s regulatory body approved Covaxin for children 2 to 18 years of age in India. A review of its efficacy indicated it was similar in children to what was seen in adults. This was an emergency use authorization. It is the second vaccine against COVID-19 granted emergency use authorization for children in India, the first being Zydus Healthcare’s ZyCoV-D. Type: Inactivated SARS-CoV-2 virus using Whole-Virion Inactivated Vero Cell platform technology. Doses: 2, 28 days apart Likely EUA Date: Not applicable in the U.S. Price: ₹150 or about $2 (U.S.), although that appears to be the low-end of the open-market price in India Efficacy: 100% against severe infection; 78% against mild, moderate and severe; 70% against asymptomatic Variants: Wildtype; can neutralize Alpha variant Abdala and Soberana 2 Vaccines The Cuban government announced on June 22, 2021 that its three-shot Abdala vaccine has a 92% efficacy rate against COVID-19. They provided no details on clinical testing. It also announced that another of its COVID-19 vaccines, Soberana 2, had an efficacy of 62% after two of its three shots. Abdala is created by Cuba’s Center for Genetic Engineering and Biotechnology. Soberana 2 was developed by a state-run biopharma company, BioCubaFarma, which oversees the Finlay Institute and Center for Genetic Engineering and Biotechnology. Reportedly, Cuba has five coronavirus vaccine candidates.

As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. “The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible,” said HHS Secretary Alex Azar. “As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump’s all-of-America approach is making progress and providing new hope in our fight against the coronavirus.” There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours. The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts. “Quickly after the emergence of this virus, we began working directly with federal health partners, academia and industry to advance medical countermeasures against COVID-19. Our staff continues to work across all sectors to expedite the development of numerous, innovative potential prevention and treatment approaches. We are also looking at pragmatic and expedited ways to make these products available to patients, while still ensuring the FDA’s standards are met,” said FDA Commissioner Stephen M. Hahn. “Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time.” To support these goals, the FDA has, among other things, redeployed medical and regulatory staff to serve on review teams dedicated to COVID-19 therapies, streamlined processes and operations for developers and scientists to send inquiries and requests and provided resources to health care providers and researchers to help them submit emergency requests to use investigational products. There are a variety of therapeutic areas being evaluated, including antiviral drugs like remdesivir that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients. There’s also interest in examining whether therapies such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length or lessen the severity of the illness. Work is also ongoing to evaluate whether existing therapies such as chloroquine and hydroxychloroquine (with or without other medications) help treat patients with COVID-19. The FDA also recognizes the potential for many different real-world data sources to complement traditional clinical studies and speed the process of evaluating the impact of potential COVID-19 therapies. To that end, the agency is advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes. The FDA’s efforts to facilitate the development of COVID-19 therapies are focused on expediting the development of data on these medical countermeasures that can meet the agency’s world-respected gold standard for full FDA approval, which relies on data from adequate and well-controlled trials to most efficiently determine if an experimental treatment can safely and effectively benefit patients. The FDA will continue to enhance and expand its work across the federal government and innovators in academia and industry to accelerate COVID-19 treatments and other medical countermeasures. The agency will outline additional information in the near future to provide a greater understanding of the full breadth of work in this area, to the extent permitted by confidentiality laws. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.