Countdown 54 Day Election

California 24 days until early voting

BIG PHARMA STEPS UP  

Trump’s rush to get out a safe vaccine prior to the election has just hit a snag.  Eight pharmaceutical  companies pledged not to release a vaccine without going through enough of Phase III testing that can be proven safe for emergency use.  The nine of the largest biopharma CEO’s pledge to make safety the main focus in coronavirus vaccine development  This is due to the administrations apparent haste to get a vaccine into the public domain before the election to help his campaign. 

The eight CEO’s pledged not to seek regulatory approval before the safety and efficacy of their experimental vaccines has been established in Phase III clinical trials. The Washington Post  said this is an extraordinary effort to bolster public faith and alleviate concerns from the general public over the safety of a vaccine rushed through to support Trump’s campaign and then not be effective.

CEO’s issued a joint statement In the Washington Post: ”We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which covid-19 vaccines are evaluated and may ultimately be approved”  The statement included a vow that the companies would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the FDA.”

Health experts say Covid-19 cases will surge in the fall and peak after election day due to the school openings and the Labor day crowds.  The loosening of restrictions will also increase the cases.  We went thru Labor day with about 40,000 cases a day the memorial day cases were half that number and we have seen the spike in the summer.  With school, cooler weather and people spending more time indoors with poor air circulation another spike in cases is anticipated. The virus is not behind us.

The pushback is both against Trump and the FDA that was willing to push the envelope with approvals rushed with shortcuts before they were fully tested and found to be safe for political purposes and not using sound science.  Trump has been obsessed with the vaccine as a tease for the October surprise and Biopharma burst his bubble.  This pledge may be putting the break on his miracle cure.  The CEO’s are more thoughtful in putting out information than Trump.  Trump has created the air of distrust with his obsession to have a miracle cure by November.

The way to avoid the projected 400,000 deaths include avoiding social gatherings, social distance and wearing a mask until a reliable and safe vaccine is fully distributed.

The author SV Date wrote a book titled “The Useful Idiot” How Donald Trump Killed the Republican Party with racism and the rest of us with the Coronavirus.  The title alone says it all.  Trump cannot stick to a message that supports his medical professionals.  Trump intent is to govern by gesture and observation and not the facts.  The problem with Trump is that he cannot wish, use magic, or lie this virus away.  At least with this pledge I feel better about the vaccines rollout when it or if ultimately happens.

THE PLEDGE:

Following guidance from expert regulatory authorities such as the FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

1. Always make the safety and well-being of vaccinated individuals our top priority.
2. Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and rigor of manufacturing processes
3. Only submit for approval or emergency use authorization after demonstrating safety and efficacy through Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the FDA.
4. Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

This pledge was signed by eight CEO’s of the largest Biopharma companies that are currently in development and some are in Phase 3 trials.  These companies are:

Astra Zeneca

Biontech

gsk

Johnson & Johnson

Merck

Moderna

Pfizer

Sanofi

Being true to their pledge the Astra Zeneca vaccine that was in Phase 3 trials has an unexpected side effect that was so severe it hospitalized a study subject.  They stopped the Trial on 9/8/20 until they could understand whether the vaccine had produced the unexpected side effect. 

The only way Trump administration can issue a vaccine prior to December is with an emergency authorization since no vaccine will have completed Phase 3 before mid 2021.  As seen an emergency authorizations may come with unknown risks of adverse side effects prior to completion and evaluation of Phase 3 tests.  This is especially true since we are only at the beginnings of Phase 3 trials for most vaccines.