Representatives of the pharmaceutical and biotech companies working to develop Covid-19 vaccines said today at a House of Representatives hearing that they are still on track to have a possible vaccine by the end of this year or the beginning of next, possibly even expecting this. fall.
When asked if they believed their Covid-19 vaccine candidates could be available in the US by the end of the year and be safe and effective, officials at vaccine manufacturers AstraZeneca, Johnson & Johnson, Merck, Moderna And Pfizer said the speed of the process will depend on the data and how well the vaccine’s development is going.
This is what some of the representatives told lawmakers:
AstraZeneca: Mene Pangalos, executive vice president of Research and Development for Biopharmaceutical Products at AstraZeneca, said providing a timeline is a “difficult question to answer,” but added that his company is “very encouraged” by the results of the phase 1 and phase 2 study. .
Pangalos noted that the results of the two closely watched trials published in The Lancet suggest that a coronavirus vaccine developed by his company in conjunction with the University of Oxford is safe and induces an immune response. However, the researchers emphasized that more studies are needed to find out if the vaccine protects people against the virus.
When asked if the vaccine candidate is approved in an emergency, He expects it to be available by the end of the year in an emergency, Pangalos said, “Yes, we do. So if we have efficacy data, we hope to have it anytime from September.”
Modern: Moderna president Stephen Hoge told lawmakers they are “cautiously optimistic” about his vaccine’s next steps and that they are “quite encouraged” by the progress. Last week, Moderna developed a Covid-19 vaccine, in association with the National Institutes of Health, that induced immune responses in all volunteers who received it in a phase 1 study.
The vaccine is now being further developed with a phase 3 trial planned for later this month.
Hoge said that assuming they can rack up cases quickly in their phase 3 study, they hope that in the fall or at the end of the year they have data they can submit to the Food and Drug Administration for a decision on whether to approve the vaccine. Hoge said at the time that they would expect to have millions of doses of the vaccine ready for deployment.
Pfizer: John Young, chief commercial officer at Pfizer, also said his company is encouraged by the first data from its initial phase 1 study regarding safety and effectiveness.
Young said they hope to complete the study by this month and submit the data to the FDA for approval. He said the large phase 3 study will be “critical” to inform the vaccine’s safety and efficacy profile.
Young said they have a “clear line of sight and clear clinical pathway” to be able to administer up to 100 million doses of vaccine products on a commercial scale in 2020 and up to 1.3 billion doses for a vaccine in 2021. Young said that despite the first encouraging signs, there is “much more work to do”.
Yesterday, Young’s company and German biotech company BioNTech announced that their Covid-19 vaccine candidate was shown to elicit “robust” antibody and T-cell immune responses in an initial phase 1/2 study.
The companies Johnson and Johnson and Merck seemed to have longer timelines. Representatives of those companies said at the hearing that their goals remain to deliver a Covid-19 vaccine next year if all goes well in the trials.
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