Research Roundup: Vaccines to undergo regulatory review, COVAX releases interim distribution plan, novel HIV vaccine approach shows promise in early trial
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Two new COVID-19 vaccine candidates, from Novavax and Johnson & Johnson (J&J), will undergo regulatory review for emergency authorization in the coming weeks. On Thursday, Novavax announced rolling reviews of its two-dose vaccine had begun by several regulatory agencies, including the European Medicines Agency, US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency, and Health Canada. Phase 3 trials of the vaccine—preliminary data from which showed 90 percent efficacy in the United Kingdom and 49 percent efficacy in South Africa—will continue while the reviews occur. The same day, J&J announced it had submitted an application for emergency use authorization from the FDA for its single-dose vaccine, after phase 3 trial data indicated the shot was 72 percent effective in the US trial and completely protective against hospitalization and death. An independent advisory committee will meet in late February to review the J&J vaccine data, after which the FDA will make a decision on authorization.
Leaders of the COVAX Facility, a global initiative aimed at providing equitable access to COVID-19 vaccines, released plans on Wednesday outlining a country-by-country forecast for vaccine distribution in the coming months. The immediate doses COVAX has secured—336 million from AstraZeneca/Oxford and 1.2 million from Pfizer/BioNTech—are expected to cover about 3.3 percent of the total population of the 145 participating countries within the first half of 2021. Doses will be distributed in proportion to each country’s population size and are anticipated to reach the most vulnerable populations, including health care workers. The details of the plan reflect an estimate of availability and are subject to change based on several factors, including the timeline of regulatory authorization for the AstraZeneca/Oxford vaccine.
IAVI and Scripps Research have announced results from a phase 1 clinical trial evaluating a novel vaccine approach to prevent HIV, which showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the virus. The targeted response was detected in 97 percent of participants who received the vaccine. The study, results of which were presented at the virtual International AIDS Society HIV Research for Prevention conference on Wednesday, demonstrated proof of concept for the vaccine approach and will set the stage for continued clinical trials refining and extending the method. IAVI and Scripps intend to move forward by partnering with Moderna to develop and test an mRNA-based vaccine that harnesses the approach to produce the same beneficial immune cells.