A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. -The BMJ
One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.
"The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “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.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”
- 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, and
- Targeting of Ventavia staff for reporting these types of problems.
One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”She added that during her time at Ventavia the company expected a federal audit but that this never came.After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial 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 data Ventavia generated for the Pfizer trial. “It’s a crazy mess.” -The BMJ
Closing Stock Market SummaryThe S&P 500 (+0.4%), Dow Jones Industrial Average (+0.5%), Nasdaq Composite (+0.3%), and Russell 2000 (+0.2%) set intraday and closing record highs on Tuesday. The market drew support from bullish earnings reactions, positive momentum, and some mega-cap support.
Avis Budget (CAR 357.17, +185.71, +108.3%) stole the earnings show, with the stock more than doubling in a short squeeze after the company beat top and bottom-line estimates. Avis shares were up as much as 218%, exemplifying the intense spirit of this bull market, and the intraday retracement didn't deter overall risk sentiment.
To be fair, the breadth of the market was more mixed in front of the FOMC policy announcement tomorrow. While nine of the 11 S&P 500 sectors closed higher, declining issues outpaced advancing issues at the NYSE and were roughly even at the Nasdaq.
The materials sector (+1.1%) was the only sector that gained more than 1.0%, but Apple (AAPL 150.02, +1.06, +0.7%), Microsoft (MSFT 333.13, +3.76, +1.1%), Alphabet (GOOG 2917.26, +41.78, +1.5%), and NVIDIA (NVDA 264.01, +5.74, +2.2%) provided individual leadership.
Conversely, the energy (-1.0%) and consumer discretionary (-0.6%) sectors lower. Tesla (TSLA 1171.97, -36.62, -3.0%) held back the latter after CEO Elon Musk said there has yet to be a signed contract with Hertz Global (HTZZ 35.06, +0.91, +2.7%) and that the deal would have no economic impact on Tesla.
Back to earnings, Pfizer (PFE 45.45, +1.81, +4.2%), Estee Lauder (EL 338.62, +13.47, +4.1%), Arista Networks (ANET 491.87, +83.30, +20.4%), Zebra Technologies (ZBRA 585.55, +42.96, +7.9%), and Under Armour (UA 21.68, +2.65, +13.9%) also saw sizable gains following their earnings reports, although not to the same extent as Avis Budget.
Elsewhere, Treasuries saw increased demand ahead of the Fed decision tomorrow, driving yields lower in a curve-steepening trade. The 2-yr yield fell six basis points to 0.45%, and the 10-yr yield fell three basis points to 1.55%. The U.S. Dollar Index gained 0.2% to 94.10. WTI crude futures decreased 0.2%, or $0.19, to $83.86/bbl.
Hedging interest remained muted amid the resolve in the major indices. The CBOE Volatility Index (16.03, -0.38, -2.3%) closed near the 16.00 level.
Investors did not receive any economic data on Tuesday. Looking ahead to Wednesday, investors will receive the ISM Non-Manufacturing Index for October, the ADP Employment Change report for October, Factory Orders for September, the weekly MBA Mortgage Applications Index, and the final IHS Markit Serfices PMI for October.
- S&P 500 +23.3% YTD
- Nasdaq Composite +21.4% YTD
- Russell 2000 +19.5% YTD
- Dow Jones Industrial Average +17.8% YTD












