47 Global Vaccine Candidates
11 Currently in Final Phase 3 Trials
[Asia Economy Reporter Ki Ha-young] Following the UK, the United States and the European Union (EU) are also expected to announce the results of emergency use reviews for the novel coronavirus disease (COVID-19) vaccines soon.
On the 2nd (local time), the UK government became the first in the world to approve the emergency use of Pfizer-BioNTech's COVID-19 vaccine. The UK Department of Health stated that the related vaccination program would begin as early as next week. According to foreign media reports on the same day, American pharmaceutical company Pfizer-German BioNTech and American pharmaceutical company Moderna have applied for use approval in the US and Europe as well.
Pfizer and Moderna Apply for Emergency Approval in US and Europe
Pfizer-BioNTech submitted an emergency use application to the US Food and Drug Administration (FDA) on the 20th of last month. Emergency use authorization is a temporary approval to increase the utilization of medicines during a public health crisis. The FDA plans to hold a meeting on the 10th to decide whether to approve the Pfizer-BioNTech vaccine. US Vice President Mike Pence stated during a phone conference with US governors on the 30th of last month that vaccine distribution could begin in the third week of December.
Pfizer-BioNTech also applied for Conditional Marketing Authorization (CMA), a system similar to emergency use, in the EU. According to the European Medicines Agency (EMA) expedited review process, quality, safety, and efficacy assessments will be conducted during the Christmas period. If the evaluation is positive, the EMA's Committee for Medicinal Products for Human Use (CHMP) plans to hold an emergency meeting by the 29th at the latest to finalize the assessment.
The EMA recommends granting conditional marketing authorization if the vaccine's benefits outweigh the risks. The EU Executive Commission, the EU's administrative body, will activate a rapid decision-making process for conditional marketing authorization among member states within a few days based on this recommendation. Accordingly, the use of the Pfizer-BioNTech vaccine in EU member states is expected to begin as early as the beginning of next year.
Moderna, competing with Pfizer-BioNTech, also applied for emergency use authorization to the US FDA on the 30th of last month. The FDA has scheduled a meeting on the 17th to review the approval of Moderna's vaccine. The US government plans to start vaccinations within 24 hours once the vaccines are approved.
Moderna also applied for conditional marketing authorization to the EMA for European distribution, but it is expected that distribution within this year will be difficult. The EMA will proceed with the review process and the CHMP will hold an emergency meeting by January 12th of next year at the latest to decide on approval.
Research on Vaccine Safety and Efficacy Continues
Even if emergency use is approved in the US and Europe, research on the safety and efficacy of COVID-19 vaccines will continue as these are not full approvals.
According to the World Health Organization (WHO) data compiled on the 27th of last month, there are a total of 49 vaccine candidates undergoing clinical trials worldwide. Among them, 11 vaccines, including the UK AstraZeneca-Oxford University, China Sinovac, Sinopharm, CanSino Biologics, US Novavax, and Johnson & Johnson, have entered the final phase 3 trials. Previously, Russia approved its domestically developed 'Sputnik V' vaccine, and the Chinese military authorized the use of the 'CanSino Biologics' vaccine internally.
The UK authorities also began the approval process at the end of last month for the vaccine developed by Oxford University and multinational pharmaceutical company AstraZeneca. The UK government expects to secure 4 million doses within this year and 40 million doses by the end of March next year upon approval.
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