As of May 14, 2021, the US Food and Drug Administration (FDA) had authorized three experimental COVID-19 vaccines for emergency use in the USA.
On December 11, 2020, the U.S. FDA Authorized the Pfizer-BioNTech COVID-19 Vaccine, known globally as Comirnaty. And on December 18, 2020, the FDA issued its second Authorization for the Massachusetts-based Moderna COVID-19 Vaccine. The FDA issued a third Authorization for the Johnson and Johnson Janssen COVID-19 vaccine on February 27, 2021. The FDA has not approved these experimental vaccines as of May 11, 2021.
On May 14, 2021, the U.S. CDC reported 120,247,887 people had been fully vaccinated against COVID-19. This data represents about 42.9% of the US population.
COVID-19 vaccines effectively prevent mild symptoms, severe disease, and hospitalizations due to COVID-19 disease. But it is still possible for a fully vaccinated person to get infected if exposed to the SARS-CoV-2 beta coronavirus. As of April 26, 2021, the total number of vaccine Breakthrough Re-Infections reported to the CDC was 9,245.
Additionally, VAERS is the USA's early warning system that monitors the safety of vaccines and is co-managed by the CDC and FDA. From December 14, 2020, through May 10, 2021, VAERS received 4,434 reports of death (0.0017%) among people who received a COVID-19 vaccine. However, VAERS reports cannot prove that a vaccine caused a problem. CDC and FDA physicians review each case report of death as soon as notified, and CDC requests medical records to further assess reports. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines, says the CDC.
Globally, experimental COVID-19 vaccines include innovative platforms such as DNA, mRNA, virus-like particle, viral vector, recombinant protein, live attenuated virus, and inactivated virus approaches. About (99) COVID-19 vaccine candidates are undergoing clinical trials and 184 pre-clinical vaccines are in development, reported GAVI.org on May 12, 2021. And the World Health Organization updated its COVID-19 vaccine authorization Listing on May 4, 2021.
COVID-19 Vaccines: Global Authorizations (14)
Convidicea Vaccine - China-based CanSinoBIO's Convidicea (Ad5-nCoV) vaccine is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
CoronaVac Vaccine - China's Sinovac Biotech's CoronaVac Vaccine is based on an inactivated pathogen. The neutralizing antibody seroconversion rate is above 90%, which indicates the vaccine can induce a positive immune response. On January 10, 2021, the Indonesian FDA issued emergency authorization for Sinovac Biotech's CoronaVac vaccine.
CoviVac Russia Vaccine - Russia's third registered vaccine is a whole-virion vaccine that uses viruses that have been inactivated, developed by the Chumakov Center. CoviVac Russia vaccine includes all the elements of the virus.
Covaxin Vaccine - India-based Bharat Biotech's Covaxin is an inactivated SARS-CoV-2 vaccine candidate. The coronavirus strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune, and was authorized in India effective January 3, 2021.
COVID-19 Vaccine AstraZeneca - UK-based AstraZeneca and the Oxford University co-developed COVID-19 Vaccine (AZD1222) is made from the ChAdOx1 virus, a weakened version of a common cold virus (adenovirus). The vaccine received the UK Medicines and Healthcare products Regulatory Agency authorization on December 30, 2020.
Covishield Vaccine - The Serum Institute of India produced a separate version of the AstraZeneca COVID-19 vaccine. The WHO granted Emergency Use Listing to the COVISHIELD' ChAdOx1-S [recombinant] vaccine on February 15, 2021.
EpiVacCorona Vaccine - Russia's Vektor State Research Center of Virology and Biotechnology developed the EpiVacCorona vaccine that relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins, conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide).
Janssen COVID-19 Vaccine - Johnson and Johnson's Janssen Vaccines & Prevention B.V. investigational SARS-CoV-2 viral vector vaccine is an adenovirus serotype 26 (Ad26) vector-based vaccine. The Janssen COVID-19 vaccine was authorized in the USA on February 27, 2021.
Moderna COVID-19 Vaccine - Massachusettes-based Moderna COVID-19 Vaccine is an mRNA vaccine candidate against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form Spike protein.
Pfizer- BioNTech COVID-19 Vaccine - The Pfizer- BioNTech (Comirnaty) COVID-19 Vaccine is an mRNA vaccine that encodes an optimized SARS-CoV-2 full-length spike glycoprotein in a 2-dose (0, 21d) regimen.
Sinopham COVID-19 Vaccine - Created by Wuhan Institute of Biological Products, under the China National Pharmaceutical Group, Sinopharm and the Wuhan Institute of Virology launched the BBIBP-CorV vaccine candidate in 2020. China's National Medical Products Administration issued authorization on December 31, 2020. The WHO listed the Sinopharm vaccine on May 7, 2021.
Sputnik V Vaccine - The Russian Sputnik V is a two-dose adenoviral-based vaccine against the SARS-CoV-2 coronavirus, which causes COVID019. Sputnik V deploys two different adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting its effect.
Sputnik Light Vaccine - The Sputnik Light vaccine is a single-dose adenoviral-based vaccine deploying adenovirus vectors rAd26, Approved by the Russian Federation on May 6, 2021.
ZF2001 COVID-19 Vaccine - China-based Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. is a protein subunit vaccine using a dimeric form receptor-binding domain as the antigen, a harmless piece of the SARS-Cov-2 virus.
COVID-19 Vaccine: Phase 3 Clinical Trials
NVX-CoV2373 vaccine - Novavax COVID-19 Vaccine (NVX-CoV2373) is a prefusion protein subunit coronavirus vaccine candidate created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. This vaccine requires a two-dose (0, 21d) regimen.
CVnCoV Vaccine - CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. CureVac's proprietary technology principle is mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
VLA2001 Vaccine - Valneva SE's VLA2001 is the only inactivated whole virus vaccine candidate targeting particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018. The phase 3 Cov-Compare (VLA2001-301) study is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 adults compared to Vaxzevria.
AG0301 Vaccine - AnGes, Inc.'s AG0301 DNA vaccine candidate against COVID-19 is a plasmid DNA vaccine encoding the SARS-CoV-2 spike protein that opens the door to infection. It is expected to prevent COVID-19 or the condition of COVID-19 patients from deteriorating. Since the vaccine is engineered to express only the spikes on the viral surface, thereby producing antibodies, it is nonpathogenic and safe.
CoVLP Vaccine - The GSK and Medicago collaboration developed a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the virus's structure responsible for COVID-19 disease, allowing them to be recognized by the immune system.
Soberana 02 COVID-19 Vaccine - Soberana 02 COVID-19 Cuba's vaccine candidate is a conjugate vaccine, in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid.
INO-4800 Vaccine - Inovio's DNA medicines are composed of optimized DNA plasmids, small circles of double-stranded DNA synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.
COVID-19 Vaccine: Phase 2 Clinical Trials
Sanofi and GSK announced a delay in launching this vaccine candidate. They plan a Phase 2b study with an improved antigen formulation. If data are positive, a global Phase 3 study could start in Q2 2021. This study's positive results would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.
The Israel Institute for Biological Research Indiana vesiculovirus COVID-19 vaccine candidate BriLife's phase 2 study will expand to 960 people, with various dose levels, beginning December 2020.
The Sichuan 'Clover' Biopharmaceuticals S-Trimer (SCB-2019) recombinant subunit vaccine candidate is targeted for the SARS-CoV-2 virus that causes COVID-19 disease. The vaccine conducts a phase 1 clinical trial in Australia, testing different boosters provided by GSK and Dynavax. Clover's S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. A Phase 2/3 clinical trial has been registered but is not yet recruiting.
COVAXX's UB-612 vaccine candidate is specifically designed to allow for the inclusion and presentation of multiple epitopes to elicit both B-cell (antibody) and T-cell (cellular) responses without enhancing COVID-19 disease.
COVID-19 Vaccine: Phase 1 Clinical Trials
Vaxart's VXA-CoV2-1 vaccine candidate is based on an oral H1 flu tablet with positive clinical study results. Phase 1, an open-label, dose-ranging study, will be conducted in healthy adults ages 18 to 55. The study’s primary objective is to examine the safety and reactogenicity of 2-doses of the vaccine.
A randomized, double-blind, placebo parallel controlled phase I/II clinical trial evaluates the new inactivated coronavirus vaccine (2019-CoV) (Vero cells) in healthy people aged 3 years and older.
AdCOVID is based on Altimmune Inc.'s adenovirus-based intranasal vaccine platform and expresses the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. AdCOVID is designed to guard the respiratory tract against viral invasion and provide downstream protection against the viral spread by stimulating both mucosal and systemic antibodies (IgA and IgG) and cell-mediated immunity.
Elixirgen Therapeutics's EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor-binding domain of the SARS-CoV-2 spike protein. EXG-5003 was optimized for intradermal injection with potential dose-sparing and safety benefits. Human clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan, in Q1 2021.
ImmunityBio hAd5 COVID-19 vaccine candidate targets the inner nucleocapsid and the outer spike protein, engineered to activate both T cells and antibodies against the SARS-CoV-2 coronavirus. Phase 1 study launched in California during October 2020.
The Phase 1 trial of bacTRL-Spike™ Vaccine for Prevention of COVID-19 is being conducted in partnership with Nucleus Network in Brisbane, Australia. Preliminary data are anticipated in early 2021.
OSE Immunotherapeutics's CoVepiT is a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19.
Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company, initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India. The Phase I/II clinical trial will evaluate the vaccine candidate's safety and immunogenicity, consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.
Vaccination decisions during the COVID-19 pandemic should be discussed between patients and their healthcare providers, says the U.S. CDC. Furthermore, the updated CDC Frequently Asked Questions about COVID-19 Vaccination are found at this link.
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The content was Fact-Checked by Dr. Robert Carlson and other healthcare professionals.