COVID Vaccine Update Pfizer One of 10 vaccines in Phase 3 trials as the race enters the final phase

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According to a World Health Organization (WHO) report published on November 3, ten potential COVID-19 vaccines are in the final phase (Phase III study) of their clinical evaluation, four of which are being developed by U.S. companies.

Among them is a vaccine developed by U.S. pharmaceutical company Pfizer in collaboration with the German BioNTech company, which has proven to be “more than 90 percent effective in preventing COVID-19,” Pfizer said in a statement on Monday.

Pfizer expects to file for emergency approval with the U.S. Food and Drug Administration (FDA) in the third week of November “after the required safety milestone has been reached”, the company said.

“We are a significant step closer to providing people around the world with the much needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated by thousands of participants over the coming weeks,” said Dr. Albert Bourla, Chairman and CEO of Pfizer.

According to the WHO, 47 vaccine candidates are currently in clinical trials, while 155 candidates are in preclinical evaluation. Here we take a look at some of the latest major COVID-19 vaccine developments worldwide.

U.S.A.

Besides Pfizer, three other U.S. companies are in Phase III.

Moderna

At the end of October, the Phase III study for mRNA-1273, the vaccine candidate being developed by the Massachusetts-based biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, completed recruitment of 30,000 participants.

“Moderna will decide whether to submit a dossier to the FDA for emergency approval based on an assessment of whether the potential benefits of the vaccine outweigh the potential risks once the two months of median safety follow-up have passed,” Moderna said last month.

The company confirmed that it is on track to release interim results this month, Reuters reported in October.

Novavax

On Monday, Maryland-based biotechnology company Novavax announced that the FDA has granted “Fast Track Designation” for its vaccine candidate NVX-CoV2373.

“The FDA decision […] reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” said Dr. Gregory Glenn, President of Research and Development at Novavax.

The company expects to initiate a Phase III trial in the US and Mexico by the end of this month, Novavax said in a statement on Monday.

Novavax started a Phase III trial in the UK in September. Recruitment of participants for this study, which is being conducted in partnership with the UK government’s Vaccines Taskforce, is expected to be completed this month. Interim data could be available early next year, the company said.

Johnson & Johnson

Janssen, a division of Johnson & Johnson, paused the Phase III study of its vaccine candidate last month because of an “unexplained disease” in one of its participants.

Testing of the vaccine resumed last month in the U.S., while the trial in Brazil was approved for resumption this month.

UNITED KINGDOM
University of Oxford/AstraZeneca

Production of the vaccine candidate AZD1222, which is being developed by the University of Oxford and the British-Swedish pharmaceutical company AstraZeneca, began on Monday in the Australian state of Victoria, even before the completion of the Phase III study.

The manufacturer CSL intends to produce approximately 30 million doses.

CSL’s Chief Scientific Officer, Andrew Nash, said: “We are doing this ahead of schedule so that if the clinical trial is positive, with the result we are aiming for, […] the vaccine will be available for distribution to the population in the short term,” he said.

Imperial College London

Last month, Imperial College London announced a new partnership with Indonesia to work on its COVID-19 vaccine, which has been in development for about six months.

Participants in the vaccine trial of the vaccine “responded well” according to a September update by Professor Robin Shattock, Imperial team leader.

The university hopes to begin a larger study with 20,000 volunteers in 2020, and global trials are expected to begin in the course of

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