Revisiting The Coronavirus Vaccine Race: Updates On The 10 Candidates In Clinics

The global economy is slowly emerging from lockdowns enacted to beat back the coronavirus.

The pandemic isn't going anywhere, however, and hopes of a return to a semblance of normal rest heavily on the speedy development of vaccines against SARS-CoV-2, the virus that causes COVID-19.

Fast-Tracking Vaccine Programs

Vaccine development typically takes about 10-15 years, as it has to go through the same general pathway as that of drugs and biologics. With the advent of new classes of vaccines such as DNA and mRNA vaccines, development timelines could be tightened relative to traditional vaccines.

Pandemics in recent history such as the MERS and SARS, also caused by coronaviruses, set in motion several R&D programs that have come in handy in today's scenario, as the new coronavirus shares 80% of its traits with its predecessors.

Public-private partnerships have been forged to expedite vaccine programs. In mid-April, the National Institutes of Health announced a co-operative framework involving several biopharma companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA and the European Medicines Agency for expediting drug and vaccine research. Federal agencies have extended funding for companies with promising vaccine candidates in their pipeline, and this has given them the freedom to focus on research without having to worry about finances.

The U.S. government recently launched the "Operation Warp Speed" project, which has among its objectives ensuring the availability of substantial quantities of a safe and effective vaccine for Americans by January 2021.

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US Government Backs 5 Vaccine Candidates

In order to narrow the focus on the most deserving vaccine candidates, the Trump administration has shortlisted five from a crowded field and will likely make an announcement in this regard in the next few weeks, the New York Times reported.

The shortlisted companies are, according to the Times:

Moderna Inc MRNA
The Oxford University/AstraZeneca plc AZN combination
Johnson & Johnson JNJ
Merck & Co., Inc. MRK
Pfizer Inc. PFE

Incidentally, Merck was a late entrant in the vaccine race, with the pharma giant announcing partnerships and deals to develop COVID-19 treatments and vaccines only recently.

10 Vaccine Candidates In Clinics, 123 More In Labs

A June 2 document from the World Health Organization showed that 10 vaccine candidates are in the clinics and 123 more are being evaluated in animal studies. Among the 10 vaccine candidates being tested in human studies, five are developed by Chinese firms or institutions. Here's an update on the 10 vaccines in the clinics:

University Of Oxford/AstraZeneca

The vaccine developed by the University of Oxford in collaboration with AstraZeneca was codenamed ChAdOx1 nCoV-19, a weakened version of a common cold virus that causes infections in chimpanzees.

It has been genetically modified to make to prevent it from replicating in humans. After the university tied up with AstraZeneca, the vaccine candidate was renamed as AZD1222. AZD1222 is in a Phase 2/3 trial, with the university enrolling participants for the study in late May.

Results from an ongoing Phase 1/2 trial could be available in mid-June; a university official was quoted as saying mid-May. AstraZeneca has received over $1 billion in BARDA funding for the development, production and delivery of the vaccine starting this fall.

In late May, Adrian Hill, one of the lead investigators of the vaccine program, suggested the vaccine has only a 50% chance of succeeding, as the viral incidence receded in the community.

Moderna

Moderna, which is collaborating with NIAID for developing an mRNA vaccine, codenamed mRNA-1273, said recently it has dosed the first participant in a Phase 2 trial. The company also released interim data for its vaccine candidate from a NIAID-sponsored Phase 1 study, which showed dose-dependent increases in immunogenicity between prime and boost within the 25-microgram and 100-microgram dose levels. Moderna has prepped for scaling by forming an alliance with Swiss CDMO Lonza.

CanSino Biological Inc./Beijing Institute of Biotechnology

CanSino, which was the first to begin vaccine testing, announced last week the publication of Phase 1 data of its vaccine candidate Ad5 that showed most people developed immune responses.

Yet he number of people developing neutralizing antibodies — the ones that count for preventing infection — was 75% among those who received the high dose and 50% among those who received the medium or low dose.

A Phase 2 study of Ad5 was started in April and is underway. Ad5 is a genetically engineered adenovirus that delivers the gene encoding the spike protein of the SARS-CoV-2 into human cells.

Wuhan Institute of Biological Products/Sinopharm

The combo's vaccine candidate entered Phase 2 trials April 24, according to Xinhua.

The Phase 1 trial is ongoing, the report said at that time. Sinopharm, one of the partners, seemed to suggest it will take one year of evaluation to determine the efficacy and safety of the inactivated vaccine candidate.

Sinovac

Sinovac, which began working on an inactivated vaccine candidate in January, said recently it is 99% confident in its vaccine candidate, codenamed CoronaVac. The candidate is in a Phase 1/2 trial. The company recently received $15 million in funding from private investors in lieu of a stake in the company.

Novavax

Novavax, Inc. NVAX identified its vaccine candidate, codenamed NVX-CoV2373, in early April. The vaccine candidate is a stable prefusion protein made using the company's proprietary nanoparticle technology, with Matrix-M adjuvant incorporated to enhance the immunity response of the vaccine.

The company said May 25 it enrolled the first participant in the Phase 1 portion of a Phase 1/2 study it has initiated, with results from the Phase 1 portion expected in July. In mid-May, the company announced an award of an incremental $384 million in funding by the Coalition for Epidemic Preparedness Innovations. On Wednesday, AGC Biologics said it has been tasked with manufacturing Matrix-M adjuvant by Novavax.

Beijing Institute Of Biological Products/Sinopharm

State-affiliated Beijing Institute of Biological Products, which is developing an inactivated vaccine in a Phase 1/2 trial, has started the Phase 2 trial, a post on the WeChat account of the Chinese state-owned Assets Supervision and Administration Commission said.

Pfizer/BioNTech

Pfizer is collaborating with German biopharma BioNTech SE – ADR BNTX for vaccine development. BioNTech is evaluating four vaccine candidates in its BNT162 program. These are mRNA vaccines combined with a lipid nanoparticle formulation. BNT162 is being tested in separate Phase 1/2 trials in Europe and the U.S. Pfizer will be vested with the responsibility of scaling up at risk.

Institute Of Medical Biology, Chinese Academy Of Medical Sciences

In mid-May, the institute received approval for commencing a Phase 1 study.

Inovio

Inovio Pharmaceuticals Inc INO, which is developing a DNA vaccine codenamed INO-4800, said in its May 11 earnings release it has completed enrollment in a Phase 1 study.

It anticipates commencing a Phase 2/3 efficacy trial in summer, subject to regulatory approval. Inovio has received funding from the CEPI as well as the Bill & Melinda Gates Foundation.

Among others, J&J, which has identified a lead vaccine candidate, plans a clinical study by September. The company expects the first batches of a vaccine to be available for emergency use authorization by early 2021.

Several other companies are also in the fray, including Sorrento Therapeutics Inc SRNE, Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY.

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