Transparent COVID Vaccine Key to Public Confidence

There is little question in the scientific community now that Pfizer and Moderna are the two most likely companies to develop viable vaccines — at least at this juncture.

Last week, in an effort to demonstrate just how well each is proceeding with expanded Phase III trials, the pharmaceutical giants released detailed reports of how they are evaluating their respective vaccines. This was an unprecedented move by the drug firms to provide virtually ‘real time’ data to virologists and other experts, which usually only occur at the conclusion of the studies.

Moderna and Pfizer both published information on just how individuals enrolled in their Phase III trials are being selected, how the monitoring process is conducted, as well as under what precise conditions the testing would be stopped if any problems were to develop. With Moderna, the Phase III study will enroll 30,000 participants. Pfizer’s is larger with 44,000.

It appears now the drug companies were especially worried that the public had become rightfully suspicious after Donald Trump’s claim that a safe and effective vaccine would be available before November 3rd — Election Day.

Moderna laid out a timeline essentially forecasting that it won’t be until well into 2021 before it knows whether its vaccine will work safely, but remains optimistic there may be results as to the vaccine’s success by the end of the year. Meanwhile, Pfizer won’t say when its study results may be completed, but its CEO has repeatedly assured both the public and investors of an initial preapproval analysis by October.

Many experts doubt that either Moderna and Pfizer will have completed their Phase III trial data by the end of the year, and it may well be sometime early next year before we know which vaccine, if not both, is headed for approval by FDA, which must occur before widespread manufacturing of millions doses can begin.

And until last week, none of the drug firms conducting widespread testing had released details of ongoing Phase III trials as Moderna and Pfizer have done. At Astra-Zeneca, officials there indicated it would publish its vaccine protocol soon — perhaps in a week. Astra-Zeneca halted its trial two weeks ago after at least one individual became seriously ill. The company’s Phase III trials have started up again in the U.K. and Brazil, but not in the United States. The FDA has said that any vaccine to win approval must be at least 50% effective against the coronavirus.

The timetable Moderna proffered appears to be more in line with what Centers for Disease Control Director Robert Redfield testified before a U.S. Senate committee that a vaccine for the general population most likely will not be available until the middle of 2021. Some experts are saying the average American will not have access to vaccine doses before next September or even October.

In what has become standard operating procedure for Trump, he almost immediately refuted Redfield’s testimony by proclaiming the CDC head had his facts mixed up, and that a vaccine would become available in weeks. In what was immediately cited as yet another outright falsehood by the president, the drug manufacturers Moderna and Pfizer, say sources, felt additional pressure to set the record straight by detailing Phase III trials as they move forward with tests on thousands of enrolled volunteers.

Academic and private industry scientific researchers have hailed Moderna and Pfizer’s move to open up on details of their widespread Phase III studies to allow for independent analysis of the testing process each drug-maker has devised.

Democratic presidential nominee Joe Biden last week also said that public confidence in any vaccine heading toward approval and distribution to the public must be “totally transparent” if Americans are going to believe any vaccine approved will be safe and not cause more harm than good. Biden said that Trump’s statements about a vaccine becoming available in a few weeks — before November 3rd — have shaken the public’s confidence in the process of developing any workable immunization against the coronavirus — now responsible for 200 thousands deaths in this country, and with more than 6.8 million U.S. cases.