A Pfizer executive said the company is aware of the alleged data fraud suspicion in its clinical trials of the Covid-19 vaccine Cominarty and conducts an internal review.
Pfizer Vaccine Vice President Ralf Rene Reinert said at an online meeting that the company confirmed the article published by the British Medical Journal (BMJ) and began taking steps for necessary measures. A whistleblower recently alleged that Pfizer falsified data and failed to promptly pursue reports of adverse events in its Covid-19 vaccine trials raised questioned over data integrity, regulatory oversight.
The BMJ report claimed that Texas contract research company, Ventavia Research Group, falsified data, unblinded patients, employed inadequately trained vaccinators in Pfizer’s pivotal phase 3 clinical trials of Cominarty that provided important data leading to its approval.
It added that the 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 U.S. Food and Drug Administration (FDA) but was fired shortly after. BMJ explained that Jackson provided dozens of internal company documents, photos, audio recordings, and emails.
“We were disappointed by the recent article published by BMJ that failed to contact us before making the publication to request for analysis,” Reinert said. “We have to remember that the results of the clinical trials of our vaccine met the primary endpoints and equaled to the data collected in a real-world setting.”
He emphasized that Cominarty showed a similarly high protection effect in all age groups against Covid-19 in clinical trials and real-world, saying that the vaccine is still effective.
After commenting on the recent allegation about falsified clinical trials, Reinert stressed that vaccines and antiviral therapies are both necessary to overcome the Covid-19 pandemic.
“Antiviral therapies can treat patients but cannot prevent infection, which only the vaccine can do,” he said.
Pfizer has been developing an oral antiviral drug Paxlovid for Covid-19, which requires patients to take three pills twice a day for five days.
Reinert also provided various data concerning the need for booster shots.
The Pfizer executive said the effectiveness in preventing symptomatic infection and hospitalization for severe conditions decreased to 40 percent six months after receiving the first complete Pfizer vaccine. However, he added that the booster shots strengthened the immune response and pulled the prevention effect back to about 95 percent.
“As our vaccine works against dominant Delta variant and can respond to breakthrough infection, I believe the booster shot can help overcome the pandemic,” Reinert said.
Regarding the necessity of booster shots in high-risk groups and adults, he showed the safety and preventive effects of booster shots collected in Pfizer's research data. He said that a new vaccine for variants would not be necessary for now.
Reinert pointed out that although the third dose of Pfizer's mRNA vaccine has not yet been approved in Korea, other countries have already begun establishing strategies for booster shots to maintain the vaccine's effectiveness.
He cited Israel as an example, saying the country responded to mutated Covid-19 strains by inoculating all ages using a booster shot program. Germany and the U.S. are also adopting similar measures.
“I cannot say much about the authorization of Pfizer’s booster shot in Korea as the regulatory review is ongoing, but we are discussing a plan for giving booster shots to those older than 16,” Reinert said. “I hope that booster shots to be approved as soon as possible, and the results will be similar to those seen in other countries.”