Vaccines for COVID-19: Time to Fast-Track

Vaccines for COVID-19: Time to Fast-Track


While most people are experiencing lockdown blues, scientists worldwide are working endlessly towards developing a viable vaccine candidate to knock down SARS-CoV-2, the deadly coronavirus. Research at a molecular level would help us understand the virus lifecycle and enhance our preparedness to develop strategies against SARS-CoV-2. Vaccines are one of the most practical preventive strategies which would help slow down the spread of COVID – 19 and save millions of lives.

COVID-19 Vaccine Candidates – The Frontrunners

The tremendous impact of the pandemic is paving the way for the evaluation of novel vaccine technology platforms.



As per an analysis published by Nature on 8 April, there are 115 candidate vaccines for COVID-19. Of these, 78 are active against the virus, and 37 have unconfirmed activity. The frontrunners that have transitioned into clinical development include

  • mRNA-1273 from Moderna

  • Ad5-nCoV from CanSino Biologicals

  • INO-4800 from Inovio

  • LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute.

Moderna Coronavirus Vaccine Trial Shows Promising Early Results

On 18 May 2020, Moderna announced positive interim phase 1 data for its mRNA vaccine (mRNA-1273). Moderna was very prompt in its action and initiated it’s the testing of its vaccine within two months after sequence identification of the novel virus. The company announced that the vaccine candidate was found to be safe and provoked a strong immune response in a handful of healthy volunteers. The positive interim results have propelled the way to begin larger human trials soon.

Novel Vaccine Development Paradigms

A vital feature of the various vaccines being evaluated is the diverse technology platforms harnessed. The majority of the platforms tested are not the foundation for approved vaccines, but their experience in oncology has encouraged researchers to explore the opportunities that these approaches may offer for COVID-19. Some vaccine approaches which are being evaluated include:

  • Nucleic Acid (DNA And RNA)

  • Virus-Like Particle

  • Peptide

  • Viral Vector (Replicating And Non-Replicating)

  • Recombinant Protein

  • Live Attenuated Virus

  • Inactivated Virus

Approved vaccines based on recombinant proteins for other diseases can be advantageous as they can take advantage of pre-existing production capacity, while DNA or mRNA based novel platforms can bestow flexibility in terms of antigen manipulation

Adjuvanted Vaccines – Viable Vaccines at a Lower Dose

An adjuvant is a constituent of a vaccine that helps stimulate a better immune response. Adjuvants also lower the amount of virus needed for the production of a vaccine, allowing for a larger stock of vaccines to be manufactured, enabling vaccination of more people without compromising protection. GlaxoSmithKline, Seqirus, and Dynavax have committed to making licensed adjuvants with novel COVID-19 vaccines developed by other companies.

Need for Collaborations

Collaborations would play an essential role in ensuring that promising vaccine candidates can be manufactured in sufficient quantities and delivered to all affected areas. Strong international coordination and cooperation between companies, regulators, health authorities, and the government is the need of the hour.

The Coalition for Epidemic Preparedness Innovations (CEPI) has recently issued a call for funding to support global COVID-19 vaccine development efforts guided by three imperatives: speed, manufacture, and deployment at scale, and global access. “We maintain a dynamic portfolio management approach and will make our enabling science resources available globally. We urge the global vaccine community to collectively mobilize the technical and financial support needed to successfully address the COVID-19 pandemic through a global vaccination program, and provide a strong base to tackle future pandemics.”

Challenges

The ground-breaking efforts to vaccine development are currently unprecedented in terms of scale and speed. Given the emergency, there is a ray of hope that vaccines could be available by early 2021; however, this would require exceptional efforts and would represent a revolutionary change from the traditional vaccine development pathway, usually taking years. The paradigm shift will require innovative regulatory reforms and a scale-up of manufacturing capacity.


The current scenario depicts companies collaborating to ensure rapid vaccine development. The number of vaccine candidates and novel approached surely generates positivity; however, the road to success will be challenging, and roadblocks are almost inevitable. Though data from the antiviral remdesivir trial is encouraging, a vaccine will ultimately be the lifesaver.


References



Frequently Asked Questions

In which cases the extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible?

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.

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