Moderna’s COVID-19 Vaccine Unlikely To Be Available To Public Before Spring, 2021; Initial US FDA Authorization Would Be Sought In Late November Medicines & Vaccines 01/10/2020 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Moderna’s mRNA research and innovation centre Moderna intends to seek US Food and Drug Administration emergency authorization for its COVID-19 vaccine candidate for frontline medical workers by November 25th at the earliest, and only in late January for use in the general population. That means that the vaccine, if approved on schedule, would only be available for widespread distribution to the general population in spring, 2021, said Stéphane Bancel, CEO of Moderna Therapeutics. Speaking at a Financial Times’ sponsored US Pharma and Biotech Conference on Wednesday, Bancel said “I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine.” This matches with what public health experts have predicted. Bancel’s announcement of the timeline appeared to remove the Moderna vaccine, if not other vaccine candidates, from the political turmoil around the November 3rd US presidential elections. US President Donald Trump had recently expressed hopes that a vaccine would be approved before he stands for re-election. While FDA officials have set guidelines requiring further safety checks after evidence of the vaccine’s efficacy is demonstrated, Trump had even suggested he might override that. Stéphane Bancel, CEO of Moderna In fact, sufficient data on the effectiveness of the Moderna vaccine should be available by November, according to a Bancel interview with CNBC. However, in order to comply with the FDA guidelines requiring at least half of the trial participants to have undergone at least two months of screening after their second injection, the timeline for seeking FDA approval for the vaccine, even on an emergency basis, was set back, he said. Among the two other vaccine candidates already in late-stage, Phase 3 testing, including AstraZeneca and Pfizer, Pfizer’s candidate is the one most likely to have enough data of its vaccine by late October. Due to the shorter period of time required between Pfizer’s two shots, the company’s trial has operated on a faster timeline than that of Moderna’s Bancel explained. FDA Widens Probe into AstraZeneca COVID Vaccine AstraZeneca’s timeline has been stalled by reports of severe side effects among at least two trial participants. And in a related development, the US FDA said it would widen its probe into those events, following its decision in early September to halt the late-stage US trials. Trials were also paused in the United Kingdom, Brazil and South Africa after a participant in the UK became ill, reportedly with a spinal inflammation called transverse myelitis – but they have since resumed. According to a recent report, the FDA will examine data from earlier trials of similar viral vector vaccines designed by the Oxford University researchers who are AstraZeneca’s COVID-19 vaccine partner, in order to determine if similar side effects were present in other vaccine trials as well, indicating a common thread. Chills, Fever and Body Aches Reported By Moderna, Pfizer Trial Participants While most clinical trials are cloaked in privacy and secreacy, some of the participants in the Phase 3 Moderna and Pfizer trials have spoken freely to media about their experiences. In a series of interviews with CNBC, participants reported symptoms of high fever, body aches, headaches and exhaustion after receiving the candidate vaccines. The side effects were experienced most intensely and sometimes severely after the second dose, lasting up to a day, described by one participant as “full on COVID-like symptoms.” But they said that they felt that the side effects from the vaccine would be well worth it to protect themselves against the SARS-CoV-2 virus that causes COVID-19. Both Moderna and Pfizer have recognized the potential for their vaccines to induce such “mild” side effects similar to mild COVID-19 symptoms. In Pfizer’s Phase 1 study, the majority of recipients of the vaccine were reported to have experienced “short-lived fever, mostly mild to moderate in severity.” This, however, does not impact the safety of the vaccine, according to spokespeople of the companies. In light of the concern over the safety and efficacy of a potential vaccine, some vaccine researchers fear that a lack of communication of the potential side effects of the vaccine to the public could cause widespread backlash and decisions to not get the COVID-19 vaccine. Study Finds that Young Adults are Biggest Superspreaders in Coronavirus Pandemic Meanwhile, in other coronavirus science developments, the largest ever contact tracing study in the world published Wednesday in the journal SCIENCE found that the primary source of COVID-19 spread is young adults. It found that infection probabilities ranged from 4.7-10.7 percent. Approximately 8 percent of patients accounted for 60 percent of new infections. “The young to middle adult age group is the one that is coming into contact with people…They are the ones taking the disease from one place to the other,” said Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy. The findings also contradicted the belief that children are less likely to catch the coronavirus. The researchers identified a high prevalence of infection among same-age contacts. These results may influence decisions to re-open schools. The study emphasized surveillance and contact tracing as critical to effective public health responses to COVID-19. Image Credits: Moderna, Moderna. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. 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