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COVID-19 Vaccine: The latest updates

By Apollo 24/7 (Update as on 26th September 2020)- 16 October 2020

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As on 26 September 2020, more than 150 COVID-19 vaccine candidates worldwide are in development. Coordinated global efforts to develop and deploy an effective COVID-19 vaccine to counter the highly contagious Coronavirus are picking up pace. The World Health Organization (WHO) is coordinating the COVAX initiative, which aims to ensure that all countries, including rich, developing and poor economies, have access to a safe and effective vaccine. So far, 156 economies have signed up for COVAX, which represents more than two-thirds of the world’s population, with an aim to deliver 2 billion doses by the end of 2021.

Updated approval criteria for the COVID-19 vaccine by the USFDA and CDSCO

The updated guideline released by the US Food and Drug Administration (USFDA) on June 30, 2020, stated that ‘the primary efficacy endpoint estimate for a placebo-controlled efficacy trial should be at least 50%’. This means that the FDA will only approve an emergency use authorization (EUA) for COVID-19 vaccine candidates that have at least 50 per cent efficacy. 
In India, the Central Drugs Standard Control Organization (CDSCO) has also released a draft regulatory guideline vaccine which states that COVID-19 vaccine candidates should show at least 50 per cent efficacy during phase 3 of clinical trials for them to be approved and widely deployed.

Snapshot of various COVID-19 vaccines in Phase 3 trials

SN.

COVID-19 Vaccine Developer/Manufacturer

Type of vaccine candidate/platform

Doses

Route of administration

1

Wuhan Institute of Biological
Products + Sinopharm (China)

Inactivated vaccine

2 (0, 14 or 0, 21 days)

Intramuscular (IM)

2

Sinovac (China)

Inactivated vaccine

2 (0, 14 days)

Intramuscular (IM)

3

Moderna + National Institute of Allergy and Infectious Diseases (NIAID) (US)

RNA

2 (0, 28 days)

Intramuscular (IM)

4

CanSino Biological Inc (China)

Non-Replicating Viral Vector

1

Intramuscular (IM)

5

University of Oxford + AstraZeneca (UK)

Non-Replicating Viral Vector

1

Intramuscular (IM)

6

Gamaleya Research Institute (Sputnik V, Russia)

Non-Replicating Viral Vector

2 (0, 21 days)

Intramuscular (IM)

7

Beijing Institute of Biological
Products + Sinopharm (China)

Inactivated vaccine

2 (0, 14 or 0, 21 days)

Intramuscular (IM)

8

Pfizer + BioNTech (US)

RNA

2 (0, 28 days)

Intramuscular (IM)

9

Janssen Pharmaceutical Companies

Non-Replicating Viral Vector

2 (0, 56 days)

Intramuscular (IM)

           

  • Oxford-AstraZeneca: On September 8, 2020, the Oxford-AstraZeneca COVID-19 vaccine paused clinical trials for a safety review due to an adverse reaction in one participant in the United Kingdom. The trial’s enrolment was put on hold after a participant reported a “suspected adverse event” (side effect caused directly due to the drug or vaccine) in the form of ‘unexplained neurological symptoms’. Presently, the nature of the event, time of occurrence, recovery of that patient and other details are being reviewed, but the trials have resumed in the UK and India.
  • Sputnik-V: In late September 2020, Sputnik-V was made available for the common public via civil circulation in Moscow. In India, clinical trials for the Sputnik-V vaccine may begin in the next few weeks. It was also reported that the Russian direct investment Fund (RDIF) and Dr. Reddy’s Laboratories are discussing a phase 3 trial in India for this vaccine. Additionally, about 100 million doses of Sputnik-V will be supplied by RDIF later in 2020.
  • J&J (Johnson & Johnson) – Janssen’s COVID-19 vaccine: J&J’s phase 3 trial will enrol about 60,000 participants from 3 continents including countries like the United States, Brazil, Argentina, Chile, Colombia, Mexico, Peru, and South Africa. The J&J’s Coronavirus vaccine is not required to be cooled or frozen, unlike other vaccine candidates. Its innovative technology of single-shot dose along with no special storage condition criteria makes it an interesting play in the race for a COVID-19 vaccine.
  • Moderna: On July 27, 2020, Moderna announced that it has started phase 3 trial which will be conducted on about 30,000 participants from the USA. The company has said that they will request for emergency authorisation for high-risk groups if the vaccine proves effective. The approval is expected in early 2021 with the possibility of an earlier approval as well.
  • Pfizer-BioNTech: Pfizer and BioNTech’s clinical trial will enrol about 30,000 volunteers (aged 18-85 years) in the US and other 120 sites globally. If the Phase 2/3 trial is successful for this vaccine, then the company will seek emergency authorization in early October 2020. If approved, Pfizer will supply 100 million vaccine doses by the end of 2020 and around 1.3 billion doses by the end of 2021. 
  • Sinovac (Coronavac): Sinovac (a Chinese pharma company) in collaboration with Butantan (a Brazilian research Centre) got a nod from the Brazilian regulatory agency to move to phase 3 on July 3, 2020. Coronavac has already been injected in about 1000 people in China under an emergency use provision. In phase 3, this inactivated Coronavirus vaccine will be injected to more than 24,000 people who participated from Brazil, Turkey, and Indonesia, including trials scheduled for people from Bangladesh and Chile. 
  • Sinopharm: The Ministry of UAE has authorized the participation of about 15,000 participants in the phase 3 trial of Sinopharm’s COVID-19 vaccine. The company initiated its phase 3 trial in Abu Dhabi (UAE) in July 2020. At least 5,000 volunteers from Abu Dhabi and 6,000 volunteers from Bahrain will be part of the phase 3 trial. According to the company’s spokesperson, if approved the vaccine will be probably available in the world market in December 2020.
  • CanSino Biologics: This vaccine, developed by China-based CanSino Biologics, Beijing Institute of Biotechnology, and Academy of Military Medical Science, announced the launch of phase 3 trials of the Ad5-nCoV vaccine in Russia, Brazil, Saudi Arabia, and Chile. In August, Saudi Arabia had announced that it would begin phase 3 trial on about 5000 volunteers. On September 21, 2020, Russia’s Petrovax Company started phase 3 trial of this vaccine.

Update on the Indian COVID-19 vaccine candidates

  • Bharat Biotech (Covaxin): Bharat Biotech has reached an agreement with the Washington University School of Medicine in St Louis, USA to develop, conduct clinical trials and distribute a nasal vaccine candidate for COVID-19. Bharat Biotech is also planning to start phase 3 trials in various states in India, starting in October. 
  • Zydus Cadila (ZyCov-D): Zydus Cadila initiated phase I & 2 trials in July and announced that it will begin its phase 3 trial in the next few weeks. It is the second Indian pharma company to get such approval after Bharat Biotech’s Covaxin. 
  • Oxford-AstraZeneca (Covishield): In India, the Oxford-AstraZeneca Coronavirus vaccine, called ‘Covishield’, was given the nod to resume phase 2 and 3 trials of this vaccine, after a brief global pause. Indian Council of Medical Research (ICMR) has approved 10 medical institutes for conducting phase 2 and 3 trials from September 2020 onwards. Recently, 2 hospitals of Mumbai and 1 hospital of Pune have started conducting phase 2 and 3 trials of the Covishield.
  • In addition to these, more vaccine candidates from India like Gennova Biopharmaceuticals and Biological E are completing COVID-19 vaccine development and entering the clinical trial phase.

What has been the learning from the temporary pause of Oxford-AstraZeneca COVID-19 vaccine trial?

After finding an adverse event in a participant in the Oxford-AstraZeneca clinical trial, researchers with the Data and Safety Monitoring Board (DSMB), an independent group, are looking out for the similar types of adverse events reported by other ongoing trials globally. The United States FDA has indicated that the US trial of the Oxford-AstraZeneca COVID-19 vaccine will remain on hold until further notification. Other countries have deemed that this vaccine candidate trial is safe and could be resumed in the UK, Brazil, South Africa, and India. While this event was a brief setback in the development of the vaccine, it reinforces the need for all prospective vaccines to go through the complete rigor of all the necessary processes and clinical trials, to deliver a successful COVID-19 vaccine.

What other steps need to be taken while we await a vaccine?

The CDC Director has recently testified that while a COVID-19 vaccine may be available for deployment by the end of the year, it will likely cover all people only several months into 2021. In his recent press conference, the WHO Director-General has also stated that even with a vaccine, there may never be a ‘silver bullet’ for COVID-19 in the medium term. Hence, it will probably require a combination of strategies to combat and contain this highly contagious virus. Hence, wearing masks, physical distancing and respiratory/hand hygiene will continue to play a critical role in keeping us safe even after the initial vaccines start to roll out.

For any questions relating to Coronavirus, do an online doctor consultation with our team of experts.
References:
  1. https://www.who.int/docs/default-source/coronaviruse/novel-coronavirus-landscape-covid-194f70ec1fe74b48c783f07d79dc416386.pdf?sfvrsn=b3737de5_1&download=true
  2. https://www.astrazeneca.com/media-centre/press-releases/2020/statement-on-astrazeneca-oxford-sars-cov-2-vaccine-azd1222-covid-19-vaccine-trials-temporary-pause.html
  3. https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/
  4. https://www.clinicaltrialsarena.com/news/astrazeneca-covid-vaccine-resumes-uk/
  5. https://www.clinicaltrialsarena.com/news/jnj-covid-vaccine-phaseiii/
  6. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19
  7. https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate
  8. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
  9. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0
  10. https://www.clinicaltrialsarena.com/news/sinopharm-covid-vaccine-uae-trial/
  11. https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-3-efficacy-trial-covid-19-vaccine-united
  12. https://www.mcri.edu.au/BRACE/trial-update
  13. https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/
  14. https://www.clinicaltrialsarena.com/news/petrovax-covid-vaccine-dosing/
  15. https://www.precisionvaccinations.com/vaccines/ad5-ncov-covid-19-vaccine
  16. https://www.nejm.org/doi/full/10.1056/NEJMp2026913

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