Following the recent FDA emergency approval granted to COVID-19 vaccines from Pfizer and Moderna, three other drugmakers are readying their coronavirus vaccines for launch in early 2021 that could help reach herd immunity more quickly, according to a report by Barron’s.

AstraZeneca Plc (Cambridgeshire, England;) is conducting trials of its COVID-19 vaccine candidate developed by the University of Oxford (Oxford, UK), in addition to Novavax, Inc. (Gaithersburg, MD, USA) and Johnson & Johnson (New Brunswick, N.J., USA) testing their respective coronavirus vaccines.

AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released to begin vaccinations early in the New Year. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorization for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunization of individuals 18 years or older. The authorization recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorization during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

Another drugmaker Novavax has initiated PREVENT-19, its pivotal Phase 3 study in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated. NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’s recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels. The company is also currently conducting a large pivotal Phase 3 clinical study in the UK, a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the US and Australia. Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions.

Meanwhile, Johnson & Johnson has completed full enrolment for its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of its investigational Janssen COVID-19 single-dose vaccine candidate with approximately 45,000 participants. Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021. If the data indicate the vaccine is safe and effective, the company expects to submit an Emergency Use Authorization application to the FDA in February 2021. Other health regulatory applications around the world will be made in parallel. A separate Phase 3 clinical trial of the investigational Janssen COVID-19 vaccine candidate to explore a two-dose regimen of Janssen’s vaccine candidate (ENSEMBLE 2) is also ongoing. 

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