Pfizer Soars as Vaccine Prevents 90% of Covid Cases in Study

The data do have limits. It isn’t known how well the shot works in key subgroups, such as the elderly. And it isn’t known whether the vaccine prevents severe disease, as none of the participants who got Covid-19 in this round of analysis had such cases, said William Gruber, Pfizer senior vice president for vaccine clinical research and development.

Outside researchers said they would need much more data, including the safety information, to assess how good the vaccine is. Assuming the encouraging early results are upheld and the vaccine is approved, use in the general public would still be a ways off, with those at the highest risk likely to get it first.

Assuming the vaccine clears the final hurdles, attention will rapidly shift to rolling it out across the world. The challenges will be immense: The companies have agreed to supply deals with the U.S. government and with other countries, but it’s widely expected that front-line medical personnel, essential workers and at-risk groups will receive any authorized shot first.

U.S. states have been working on distribution plans, but many can’t finalize arrangements until it’s clear what shot will be given, as the top candidates have varying requirements for storage and transport. Pfizer’s vaccine, for example, must be kept at ultracold temperatures.

“The rollout of vaccines requires the near-flawless execution of an interconnected chain of processes,” according to an Oct. 21 report from the Boston Consulting Group. In addition to handling the products, officials will need to mount public education and outreach campaigns, monitor whether vaccines have any safety or efficacy issues once they reach a broader population, and

Two-Shot Regimen
The Pfizer vaccine is being tested in a two-dose regimen. The trial started in July, and since most participants only received their second dose much more recently, nobody knows how long any protection will last.

However, the strong reading from the first large-scale trial to post efficacy results bodes well for other experimental vaccines, in particular one being developed by Moderna Inc. that uses similar technology. Its big trial could generate efficacy and safety results in weeks. If that study succeeds as well, there could be two vaccines available in the U.S. by around year-end.

Pfizer expects to get two months of safety follow-up data, a key metric required by U.S. regulators before an emergency authorization is granted, in the third week in November. If those findings raise no problems, Pfizer could apply for an authorization in the U.S. this month.

Pfizer Soars as Vaccine Prevents 90% of Covid Cases in Study, Bloomberg, Nov 9