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November 7, 2021

Pfizer whistleblower reveals data integrity issues in COVID vaccine trial

Brook Jackson, a former regional director of Ventavia Research Group, which tested Pfizer’s COVID-19 vaccine at several sites in Texas in autumn 2020, is blowing the whistle on data integrity and patient safety issues during the pivotal phase III trial.

Jackson said Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. According to The British Medical Journal (BMJ), quality control staff were overwhelmed by the number of problems they found.

Problems with laboratory management

After Jackson repeatedly informed Ventavia about the problems, she emailed a complaint to the Food and Drug Administration (FDA). Later that same day, Ventavia fired her. Jackson provided dozens of internal company documents, photos, audio recordings, and emails to The BMJ.

In her September 25 email to the FDA, Jackson listed concerns she’d witnessed, including:

  • Participants placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens
  • Targeting of Ventavia staff for reporting these types of problems

One photo showed needles improperly discarded in a plastic biohazard bag instead of a sharps container. Another image showed vaccine packaging with trial participants’ identification numbers left out in the open, potentially unblinding the participants.

Ventavia, which has won awards for its contract work, was not keeping up with data entry queries. ICON, the contract research organization that partnered with Pfizer on the trial, emailed Ventavia in September 2020. “The expectation for this study is that all queries are addressed within 24hrs,” ICON wrote.

ICON then highlighted more than 100 outstanding queries older than three days in yellow, including the following: “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.”

Ventavia and the FDA

In August 2021, after the full approval of Pfizer’s vaccine, the FDA published its inspections of the pivotal phase III trial. Nine of the 153 sites were inspected — none of which were Vantavia’s sites.

“The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug],” the FDA’s inspection officer wrote.

Other employees weigh-in

Two other former Ventavia employees spoke to The BMJ on the condition of anonymity over fear of repercussions, confirming the broad aspects of Jackson’s complaint.

One said she’d worked on more than four dozen clinical trials in her career but had never encountered such a “helter skelter” work environment.

“I’ve never had to do what they were asking me to do, ever,” she said. “It just seemed like something a little different from normal—the things that were allowed and expected.”

After Jackson left Ventavia, the problems persisted, according to the employee. The company didn’t have enough employees to swab all trial participants who reported COVID-like symptoms. An FDA memo from August 2021 said swabs were not taken from 477 people with suspected cases of symptomatic COVID-19.

“I don’t think it was good, clean data,” the employee said of the Ventavia data. “It’s a crazy mess.”

Since Jackson contacted the FDA in September 2020, Pfizer has hired Ventavia as a subcontractor on four other vaccine clinical trials: COVID-19 vaccine in children and young adults, pregnant women, a booster dose, and an RSV vaccine trial.

Source:

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

September 19, 2021

FDA overwhelmingly rejects Pfizer booster for anyone 16 and up

An advisory panel for the Food and Drug Administration resoundingly voted against giving Pfizer-BioNtech’s COVID-19 booster shots to those 16 and up. The panel agreed to distribute them only to people aged 65 and those at high risk of severe illness.

Members overwhelmingly voted against the recommendation for everyone 16 and older, citing concerns about the lack of evidence showing boosters are safe and effective for young people.

“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit.

The recommendation only applies to those who received the Pfizer vaccine and does not impact those who received Moderna or Johnson & Johnson.

Source:

FDA advisory group rejects Covid boosters for most, limits to high-risk groups

September 6, 2021

Pfizer working on COVID-19 pill

Pfizer is working on a pill to combat COVID-19.

The company announced that its first participant entered the second trial phase of the three-phase study of its oral antiviral. The pill is intended to mitigate symptoms and hospitalizations.

The treatment is administered in 12-hour increments for five days to people who are symptomatic but not hospitalized. The trial will consist of 1,140 participants who will either receive the pill or a placebo.

If successful, Pfizer’s oral antiviral could help alleviate the strains on health care systems, as the treatment could help reduce the number of hospitalizations.

Source:

Could There Be a Daily COVID Pill? What We Know About Pfizer Drug Trial

April 16, 2021

Pfizer: People need third dose of COVID-19 vaccine within a year

Thank God it’s Friday, America!

According to Pfizer CEO Albert Bourla, people who have been fully vaccinated with their COVID-19 vaccine would “likely” need to secure another shot within a year. He added that people may need to get injected every year in order to remain protected against the virus. This is too many injections.

The proposal of several Democratic House members to expand the Supreme Court will face an uphill battle not only from Republicans but also from their party mates. Per House Speaker Nancy Pelosi’s standpoint, President Joe Biden’s 36-member commission to review such measures is the way to go.

Russian President Vladimir Putin has ordered over 100,000 Russian troops standby at Ukraine’s border on Wednesday. The massive show of force is a testament of a future war between the two countries. Please keep calm, Mr. Putin!

Google Earth has unearthed a new 3D time-lapse feature, an interesting quick watch to see. Users can see any part of the planet, change the camera angles and pick whatever year they would like to see (from 1984 up to 2020). Amazing!

Experts have forecast that people would be able to video-chat each other via holograms by 2030. How exciting to feel like I’m doing the Star Wars thing!

During Prince Philip’s funeral procession, Queen Elizabeth has ordered Prince William and Prince Harry to be distant from their grandfather’s coffin. The sibling will likely have a close encounter for the first time, after Prince Harry with his wife Meghan Markle decided to abandon the royal family. I don’t think Prince Philip would be happy about that.

Happy weekend,

Fraser Dixon

Sources

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