COVID-19 Vaccines Entering Home Stretch

The first shots of a vaccine against the coronavirus may be administered before year’s end if all goes according to schedule.  Biotech company A researcher works in a lab run by Moderna Inc, in an undated still image from video.The FDA will get a closer look at the data than what the public has seen through company press releases.  The agency will also share that data with a group of experts outside the agency and not affiliated with the manufacturers, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The FDA does not have to get VRBPAC’s recommendation in order to issue an emergency use authorization. But the Initial doses of the Pfizer COVID-19 coronavirus vaccine have been flown into the United States from Belgium ahead of a planned nationwide rollout in December.Limited supply Moderna said it expects to have 20 million doses available in the United States by the end of 2020. Pfizer forecasts 50 million doses worldwide this year.  That will not be enough for everyone. Both vaccines require two doses for full potency, which means only 35 million people can be fully immunized. The CDC’s Advisory Committee on Immunization Practices (ACIP) has scheduled a vote Tuesday, Dec. 1 on recommendations for allocating the initial supplies of vaccine.  Front-line health care workers are widely expected to top the list.  That includes about 21 million people, according to CDC estimates. Who gets the vaccine next is a trickier question. General recommendations include the elderly, essential workers and people with medical problems that raise their risk of dying of COVID-19. The latter two categories are open to interpretation.  ACIP’s schedule for Tuesday does not appear to include making those recommendations.  “They may put that off until a time when they can be assured there will be more doses to reach more people,” Orenstein said. The next complication will be distribution. The Pfizer vaccine needs to be kept at temperatures much colder than standard freezers. Larger medical centers would likely have the equipment.  “They should get the Pfizer vaccine,” Tan said. “Save the Moderna (vaccine) for rural hospitals. But that means additional logistical challenges, because now you’ve got to separate the vaccine at the source so that they go to the right places at the right time.” Regulators will have other vaccines to consider in the coming months, as well. Pharmaceutical company AstraZeneca’s vaccine has demonstrated promising results, and drugmaker Johnson & Johnson’s vaccine is nearing the end of a clinical trial.  

No Responses

Leave a Reply