- Several global biopharmaceutical companies are among the frontrunners to develop COVID-19 vaccine, and several have advanced into clinical trials.
- AstraZeneca Oxford coronavirus vaccine has resumed clinical trials globally and expects results from late-stage trials later during the current year.
- Moderna has begun rolling review process of vaccine candidate and has bagged supply agreements with the Ministry of Public Health of Qatar and Ministry of Health, Labour and Welfare of Japan.
- Pfizer has begun rolling submission to the EMA for BNT162b2 vaccine candidate after encouraging preliminary results were received from pre-clinical and early clinical studies in adults.
- Johnson & Johnson to resume recruitment for its pivotal Phase 3 ENSEMBLE trial on Janssen COVID-19 vaccine in the US after a temporary halt.
Since the outbreak of the catastrophic pandemic, SARS-CoV-2 has taken a severe toll on human life as well as economic and financial aspects. We are already close to completing a year since the emergence of the disease, and there are still several mysteries that need to be covered, including the biology and pathology of the virus.
Many countries are struggling to contain the virus and are witnessing the second wave of infections. Although detection of the disease and treatment has improved over the period, yet the world lacks an effective solution to the disease, a vaccine.
As scientists, drug manufacturers and authorities rush towards developing a vaccine to tackle the novel coronavirus, recent quick advancements in COVID vaccine space have triggered hopes for the success of several vaccines.
Thankfully, numerous companies worldwide are among the frontrunners, including Astrazeneca, Moderna, Pfizer, Johnson & Johnson and several others have progressed into clinical trials stage.
Let us delve into the latest developments of these frontrunners in the vaccine development space.
AstraZeneca’s Clinical Trials Resumed Globally For AZD1222
Global biopharmaceutical business AstraZeneca has lately resumed clinical trials for AZD1222, the AstraZeneca-Oxford coronavirus vaccine. The trials resumed after regulators across the world including the US, UK, Brazil, Japan and South Africa confirmed that it was safe to do so.
Following the resumption of trials in other countries in recent weeks, the FDA authorised the restart in the US on 23 October 2020 after reviewing all safety data from the trials globally and concluding that it was safe to resume the trial.
In early September 2020, AstraZeneca had to voluntarily pause the vaccination across all global trials as part of the standard review process for trial safety events. The recommendations from these reviews confirmed that the trials were safe to resume.
The resumption of the vaccine trials marks the continuity in AstraZeneca’s efforts to create a vaccine that could potentially help in establishing a win over the terrific pandemic.
Now, AstraZeneca expects results from late-stage trials later during the current year. However, these results remain subject to the rate of infection within the communities where the clinical trials are being conducted.
Moderna Begins Rolling Review Process Of Vaccine Candidate, Bags Multiple Supply Agreements
Another biotechnology company Moderna, Inc. (Nasdaq:MRNA) has partnered with the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Ltd (NYSE:TAK) for purchasing and distributing 50 million doses of mRNA-1273.
mRNA-1273 is Moderna’s vaccine candidate against COVID-19. Takeda along with the support of the MHLW will import and manage domestic regulatory, expansion and supply activities in Japan to ensure timely access of the vaccine, beginning in the H1’CY21.
Moderna has also inked an agreement with the Ministry of Public Health of Qatar for the supply of Moderna’s vaccine candidate against novel coronavirus.
On 27 October 2020, Moderna announced that the rolling review process of mRNA-1273 had been started by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This news comes after the upbeat results from a pre-clinical viral challenge study of the vaccine candidate and the favourable interim analysis of the Phase 1 study of mRNA-1273 in people aged 18-55 years and beyond.
mRNA-1273’s Phase 1 interim analysis showed that the vaccine was well-tolerated across all age groups and produced quick and robust immune responses against SARS-CoV-2.
Previously, enrollment of 30,000 participants for the Phase 3 COVE study was completed by Moderna on 22 October 2020, and a major number of participants had received their second vaccination.
The growing supply agreements reflect upon Moderna’s dedication to making the vaccine available across borders as soon as possible.
Pfizer Informs On Starting Rolling Submission to The EMA For Leading Candidate
Pfizer Inc. (NYSE: PFE) along with BioNTech SE (Nasdaq: BNTX) had begun rolling submission to the EMA (European Medicines Agency) for the leading candidate from PFE’s vaccine development program against COVID-19, BNT162b2.
The rolling review commencement decision comes after receiving encouraging preliminary results from pre-clinical and early clinical studies in adults demonstrating that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant cells that target SARS-CoV-2.
Further progress to conclude the rolling review process to facilitate the final Marketing Authorization Application is planned to take place in close coordination among Pfizer, BioNTech as well as EMA’s Committee for Medicinal Products for Human Use.
The vaccine candidate BNT162b2 utilises BioNTech’s proprietary technology mRNA and is supported by the global vaccine development and manufacturing capabilities of Pfizer. BNT162b2 is currently being evaluated under a global Phase 3 study progressing worldwide at around more than 120 clinical sites.
Further, initial data from the Phase 1/2 portions of the study showed that the vaccine was well tolerated with mild to moderate adverse events across all age groups and generated dose level-dependent immunogenicity.
J&J Resumes Recruitment For Phase 3 ENSEMBLE Trial Of COVID-19 Vaccine
According to the latest update from Johnson & Johnson on 23 October 2020, the Company is in preparation to restart recruitment in the pivotal Phase 3 ENSEMBLE trial of its Janssen COVID-19 vaccine in the US after a temporary halt.
The decision to resume the trial recruitments comes after the recommendation of the independent Data Safety and Monitoring Board (DSMB) supervising the ENSEMBLE study. The preparations to resume the trial in the US are now underway after consultation with the US FDA.
In the course of the trial, one of the participants experienced a serious medical event, for which no clear cause was identified even after a thorough evaluation. Johnson & Johnson also stated that there was no evidence to prove the claim that the event was caused due to vaccine candidate.
Clearly, many companies around the world are in a race to develop an effective vaccine for COVID-19 and contribute towards combating the deadly virus. Although significant developments have been successfully reported in trials and evaluations of these vaccines, however, the chances of providing every person with access to the vaccine still seems to be a tall order.