Oxford Vaccine Progress

AstraZeneca is now reporting its AZD1222 COVID-19 mRNA vaccine could be available as early as January of next year. Long favored in the epidemiological community as one of the more likely effective and safe vaccines in development by several major pharmaceutical companies, AstraZeneca’s teaming with Oxford University is now in late-stage trials in Britain and the U.S., as well as other countries, to determine the vaccine’s efficacy and safety.

The FDA will be the ultimate authority in granting approval, and it will follow published results of the Phase III trials expected as early as late November or in December. The company will begin manufacturing millions of doses once it is convinced the vaccine is effective, which it fully expects it to be. AstraZeneca will be analyzing data from its Phase III trial participants here and the U.K., as well as in Brazil and South Africa.

Except for a brief halt in the Phase III trials in September due to one participant’s adverse reaction, AstraZeneca/Oxford vaccine has been proceeding without incident. The key question remains as to how effective will it be. The FDA has set the bar at 50% efficacy. There is some concern that any of the vaccines under development might fall below that threshold. When finally approved, AstraZeneca promises to make the vaccine available on a ‘non-profit’ basis to developing nations, and will make it available to for-profit healthcare entities here and abroad at a severely discounted cost.

AstraZeneca also is working on a therapy involving long-acting antibodies designed to boost the human immune system for several months, as well as being disseminated to vulnerable populations as a prophylactic — another line of defense at the outset of future COVID-19 outbreaks.

Other promising vaccine development includes Pfizer and Moderna, each which is conducting Phase III trials. Moderna doesn’t expect to have its vaccine ready for widespread availability to the public until likely late next spring. Meanwhile, Pfizer speculates it may apply for an FDA emergency use declaration, in which it could hopefully produce vaccine doses as quickly as late November.

All of these major vaccine initiatives couldn’t come at a more optimal time since new daily infections from coronavirus have spiked more than 45%. And hospitalizations of severe COVID cases are breaking news records across the country.