Minneapolis drug safety advocate worries COVID-19 vaccine was rushed, experts assure it’s safe

It’s been two and a half weeks since the first COVID vaccine received emergency use authorization. The Pfizer vaccine and Moderna versions are now being distributed around the world.

In Minnesota, health care workers, long-term care residents and some first responders have received the first dose. The Minneapolis Fire Chief and Metro Transit Police Chief both got their shots on Tuesday.

Developing a vaccine usually takes years, rather than months.

Kim Witczak, of Minneapolis, spoke at the FDA’s hearing on the Pfizer-BioNTech vaccine.

“Being there in person is very different from doing it virtually,” said Kim Witczak, of Minneapolis. “It’s eight hours of presentations. This year obviously everything is virtual. They are public.”

She has years of experience with FDA hearings. For five years, she’s been a consumer representative on the FDA Psychopharmacologic Drugs Advisory Committee, which looks into new psychiatric drugs.

“The public comments actually mean a lot,” she said.

Witczak also has a non-profit focused on drug safety, called Woody Matters. It was founded after her husband Woody died by suicide in 2003. According to Witczak, his death came about five weeks after he was prescribed antidepressants for insomnia. She later sued Pfizer and settled with the company.

“We don’t know about a lot of the safety side effects potentially down the road until years when millions of people take these drugs or vaccines,” said Witczak. “I know everyone wants hope and we want hope because we want to get back to our lives. There’s been so much talking about this being one of the ways to get back to our lives but […] many of us that have experienced harms in FDA approval medications, we went in with blind hope and blind faith in the system.”

With a decision coming on the Pfizer vaccine, Witczak requested to speak at the hearing and was chosen to give a presentation.

“I think we have to have healthy skepticism of all of the drugs and vaccines that are coming to market,” she said.

On Dec. 10, she explained her concerns to the FDA Vaccines and Relation Biological Products Advisory Committee as well as Pfizer.

Witczak spoke against the possibility of giving the vaccine to those who received the placebo during the trial.

“If this happens we will lose our control group,” she said during the hearing.

A control group is used as a benchmark to help determine whether side effects or successful treatment are the results of the vaccine or something else.

She also called for public access to all trial data.

“The public needs assurance that the FDA’s review was thorough and independent,” she said during the hearing.

Witczak later told 5 EYEWITNESS NEWS that she wants to know whether the vaccine will be safe in the long term.

During the more than hour long public comment period, dozens of people spoke. Some arguing the process was rushed, while others urged the FDA to move forward quickly to approve the vaccine.

Typically when a vaccine is going through the development process, there is a pre-clinical phase where additional research is completed and testing in animals is done to determine whether it will work in humans. According to the FDA, a clinical development stage follows. Lab results, manufacturing technology information and vaccine quality data is submitted to the FDA, which assess the product, including for quality and safety.

Clinical trials follow, usually with three phases. At the same time, information about the manufacturing process is also submitted to the FDA, which evaluates it.

Once preclinical and clinical programs have been completed and manufacturing details finalized, companies submit a Biologics License Application to the FDA. The agency then analyses the costs and benefits before deciding whether to approve it. In some cases, the FDA seeks input from the Vaccines and Related Biological Products Advisory Committee but is not bound by its recommendation.

“All of those steps, sequentially could take five, seven, eight years,” said Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota. “What happened with Operation Warp Speed is they said okay, let’s do them all simultaneously. We’ll do Phase 1, Phase 2, Phase 3, we’ll look at manufacturing issues, we’ll start making the vaccine,” he said. “If one makes it then we’ll go to 2. If 2 makes it, we were already working on 3, we’ll go to 3.”

Osterholm, who is also on President-Elect Joe Biden’s COVID-19 Advisory Board, called the process “ingenious.”

According to Dr. Osterholm, it’s a financial risk but he believes the results are not different than if a longer study had taken place.

“The big challenge around safety with vaccines relates to the time period immediately after the immunization, meaning what happens in the day afterward – some matter of time – in some cases the hours afterwards and then what happens in the next two to three weeks,” he said. “We have been able to observe that.”

More than 37,000 people participated. Among the half that received the vaccine, many reported side effects including tiredness and a headache. Some also suffered muscle pain, chills and a fever after receiving the vaccine.

According to the FDA, fewer than one percent of people had a serious reaction. Read the results here.

The Vaccines and Related Biological Products Advisory Committee approved Pfizer’s vaccine with a 17 to 4 vote with one person abstaining.

“I imagine that we could’ve done it any faster but at the same time any safer than it’s been done so far,” said Osterholm.

Witzcak has concerns about the long-term impacts of the vaccine.

“I think it’s really important that we don’t ever forget is that the real clinical trial is when millions and millions and millions of people start taking this vaccine around the world,” she said.

She did not speak during the FDA’s hearing on the Moderna vaccine,

The CDC is tracking negative reactions to the vaccine by asking people to report negative side effects. Two people in the UK experienced anaphylaxis after getting the vaccine.

The CDC recommends those with a history of severe allergic reaction to any ingredient in a COVID-19 vaccine should not get that vaccine. Those who’ve experienced severe reactions to other vaccines or injectable medications should talk to their doctor before getting the COVID-19 vaccine.

According to the agency, those who have a severe allergy to foods, pets or latex, or a mild allergy to a vaccine, can still get vaccinated.

Everyone who receives a vaccine should be monitored for at least 15 minutes after getting the COVID-19 vaccine.