Will we be able to defeat the novel coronavirus in just a span of a year?
The race on creating a vaccine for the novel coronavirus has long started since the first COVID-19 case surfaced a year ago in Wuhan, China. These biotech companies and pharmaceuticals have pushed through sleepless nights and work around the clock to create a safe and effective vaccine as soon as possible. With this, a handful of vaccines have been authorized worldwide, along with many more remain in development.
To update you with the current standing on the race, we listed below the nine promising vaccines created by brilliant minds across the globe, according to the COVID-19 vaccine tracker published in Regulatory Affairs Professionals Society.
As of January 7, 2021, the following vaccines have been authorized/approved.
1 | Comirnaty (BNT162b2)
Vaccine Type: mRNA-based vaccine
Primary Developers: Pfizer, BioNTech; Fosun Pharma
Country of Origin: Multinational
Authorized/Approval: UK, Bahrain, Canada, Mexico, US, Singapore, Chile, Oman, Saudi Arabia, Kuwait, EU, WHO (emergency use validation)
Background: Formerly called as BNT162b2, Comirnaty is a re-engineered nucleoside mRNA-based vaccine developed by BioNTech and Pfizer, while Fosun Pharma has licensed Comirnaty in China. The vaccine is given as an intramuscular injection (a technique used to deliver a medication deep into the muscles) in two doses 21 days apart. It then generated an immune response against SAR-CoV-2, the virus that causes COVID-19, by encoding a mutated form of the full spike protein of the virus.
Effectiveness: According to a Phase 3 data published in NEJM, Comirnaty has shown 95% effective to over 43,000 participants.
2 | mRNA-1273
Vaccine Type: mRNA-based vaccine
Primary Developers: Moderna, BARDA, NIAID
Country of Origin: US
Authorized/Approval: US, Canada, EU, Israel
Background: Biotechnology company Moderna developed mRNA-1273, a two-dose mRNA vaccine taken 28 days apart.
Effectiveness: In the pivotal Phase 3 trial of 30,000 participants at high risk for COVID-19, participants received a 100 µg dose of mRNA-1273 and another 4 weeks later or placebo injections and then be followed for up to 2 years; results published in NEJM demonstrated efficacy of 94.1% (COVE trial; NCT04470427).
3 | CoronaVac
Vaccine Type: Inactivated vaccine (formalin with alum adjuvant)
Primary Developers: Sinovac
Country of Origin: China
Authorized/Approval: China
Background: CoronaVac (formerly PiCoVacc) is a formalin-inactivated and alum-adjuvanted vaccine developed by the China-based biotechnology company Sinovac Biotech. The vaccine is administered in two doses 14-28 days apart.
Effectiveness: Sinovac representatives told Reuters that the vaccine appeared to be safe in older trial participants, and did not cause any severe side effects. Preliminary results from the Instituto Butantan trial announced by the company indicate CoronaVac is safe so far, with no serious adverse events reported. In Phase 3 trials, efficacy is above 50%, according to independent reporting from the Wall Street Journal. According to officials in Turkey, the effectiveness of the vaccine is 91.25%. The trial in Brazil was briefly suspended due to a patient death, but resumed. Results from the Phase 1/2 trials published in The Lancet Infectious Diseases indicate the vaccine has good safety and immunogenicity, with seroconversion occurring in 92.4% of participants receiving the 3 μg dose on a 0-14 day schedule and 97.4% of individuals receiving the same dose on a 0-28 day schedule.
4 | COVID-19 Vaccine AstraZeneca (AZD1222)
Vaccine Type: Adenovirus vaccine
Primary Developers: BARDA, OWS
Country of Origin: UK
Authorized/Approved: UK, India, Argentina, Dominican Republic, El Salvador, Mexico, Morocco
Background: AstraZeneca and the Oxford Vaccine Group at the University of Oxford have developed “COVID-19 Vaccine AstraZeneca” (previously AZD1222 and ChAdOx1), a chimpanzee adenovirus vaccine. In India, the candidate is being jointly developed by the Serum Institute of India and AstraZeneca, and goes by the name Covishield. Two vaccines are administered in two doses between 4-12 weeks apart.
Effectiveness: In an interim data from a Phase 3 trial in the UK, Brazil, and South Africa published in The Lancet indicate the vaccine has an overall efficacy of 70%, with vaccine efficacy at 62.1% in a group of participants receiving two standard doses and 90% in a group receiving one half dose followed by a standard dose.
5 | No official name announced (Sinopharm)
Vaccine Type: Inactivated vaccine
Primary Developers: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
Country of Origin: China
Authorized/Approved: China
Background: Researchers at Sinopharm and the Wuhan Institute of Virology under the Chinese Academy of Sciences are developing an inactivated COVID-19 vaccine candidate.
Effectiveness: The vaccine has shown a “strong neutralizing antibody response” in Phase 1/2 trials, according to a release from China National Biotec Group. Results from a Phase 1 and a Phase 2 trial published in JAMA show the vaccine candidate has demonstrated immunogenicity (the ability of cells/tissues to provoke an immune response).
6 | Sputnik V
Vaccine Type: Non-replicating viral vector
Primary Developers: Gamaleya Research Institute, Acellena Contract Drug Research and Development
Country of Origin: Russia
Authorized/Approved: Russia
Background: The Gamaleya Research Institute in Russia and Health Ministry of the Russian Federation are evaluating their non-replicating viral vector vaccine, Sputnik V (formerly Gam-COVID-Vac), in a Phase 3 trial in Russia and internationally.
Effectiveness: The Russian Direct Investment Fund (RDIF) announced the vaccine was 91.4% effective in interim trial results based on 22,714 participants, but these results have not yet been peer reviewed. Results from the two small Phase 1/2 trials published in The Lancet appear to show the vaccine has a good safety profile and “induced strong humoral and cellular immune response” in participants.
7 | BBIBP-CorV
Vaccine Type: Inactivated vaccine
Primary Developers: Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
Country of Origin: China
Authorized/Approved: China, United Arab Emirates, Bahrain, Egypt
Background: Sinopharm is developing a second inactivated COVID-19 vaccine candidate, BBIBP-CorV, with the Beijing Institute of Biological Products.
Effectiveness: Results from a paper published in the journal Cell appear to show BBIBP-CorV provides “highly efficient protection” against SARS-CoV-2 in rhesus macaques (primate) who underwent challenge against the virus. On 9 December, the UAE announced the vaccine was 86% effective, according to a statement from the country’s health ministry.
8 | EpiVacCorona
Vaccine Type: Peptide vaccine
Primary Developers: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology
Country of Origin: Russia
Authorized/Approved: Russia
Background: The Federal Budgetary Research Institution State Research Center of Virology and Biotechnology in Russia (the Vector Institute) has developed a peptide vaccine for COVID-19 called EpiVacCorona.
Effectiveness: Clinical trials of the vaccine had been completed after beginning in July, according to reporting from Reuters on September 30. Moreover, the head of the zoonotic diseases and flu department with the Russian State Research Center of Virology and Biotechnology Vector has said participants have developed immunity “a month after the first vaccination,” but no official trial data has yet been released.
9 | Covaxin
Vaccine Type: Inactivated vaccine
Primary Developer: Bharat Biotech, ICMR
Country of Origin: India
Authorized/Approved: India
Background: Bharat Biotech developed an inactivated vaccine called Covaxin in partnership with India’s National Institute of Virology.
Regulatory Actions: Bharat Biotech received restricted emergency approval from CDSCO on 3 January. No peer-reviewed studies evaluating its safety and efficacy have been published.
Effectiveness: Ongoing Phase 3 trial for its 26,000 participants, according to the Director General of ICMR, which has reached about half of its enrollment target. And on 16 December, Bharat Biotech reported that Covaxin was “safe and triggered immune responses” in a Phase 1 trial, while the first two phases of the trial did not have any major adverse events, the company said in a statement.
To further know about these approved vaccines, visit www.raps.org.
Source
Craven, J. 7 January 2021. COVID-19 Vaccine Tracker. Regulatory Affairs Professionals Society. Retrieved on 14 January 2021 from https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
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