What RIers Need to Know About Vaccines: Who Will Manage Distribution, When, and Safety Concerns

Monday, November 30, 2020

 

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Some vaccines may be available in December

The U.S. Centers for Disease Control and Prevention (CDC) are meeting on Tuesday to make determinations about who will be the first to receive the now emerging coronavirus vaccines.

Advisers to the CDC called the emergency meeting to vote on who they recommend should be the first to get a coronavirus vaccine once one is authorized.

While the CDC has the responsibility to review and approve the efficacy and safety of the emerging vaccines, it is the CDC's Advisory Committee for Immunization Practices that determines the distribution strategy and priorities.

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Across the country, states are wresting with record numbers of cases and more than 90,000 hospitalizations.

Professor Alan Rothman of the School of Pharmacy at the University of Rhode Island (URI) tells GoLocal there are many complex issues to be unraveled.

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URI Professor Alan Rothman PHOTO: URI

“Any time you are considering scaling up from giving a vaccine to tens of thousands of individuals to giving that same vaccine to hundreds of millions of individuals, there is reason for concern, and it’s of particular note that most of the data on the safety of these vaccines involves only a few months’ observation,” said Rothman, who leads URI's Laboratory of Viral Immunity and Pathogenesis

“We have to keep in mind, though, that we’re dealing with a pandemic situation, so I don’t think we have been too aggressive, at least not so far,” said Rothman.

 

Early Controversies and Complexities

Three pharmaceutical giants have announced success in the development of vaccines — Pfizer, Moderna, and Oxford/AstraZeneca, but there are complications with each.

Moderna said it will on Monday ask U.S. and European health regulators to authorize use of the company’s COVID-19 vaccine, after it was shown to be 94.1% effective in a full analysis of a pivotal study. Pfizer had already made the request.

The Pfizer and Moderna vaccines have to stored and transported at extremely low temperatures, but Rothman believes that can be overcome. 

“I think we should have the capability to meet these requirements in the U.S. -- I think it will be more challenging in some lower-resource countries,” he said. 

And, there are significant questions about AstraZeneca’s research, specifically the dosage during trials. 

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“I don’t have access to any special information, only what’s reported publicly. It has been reported that a group of subjects received a lower dose in error; exactly how that dosing error occurred is not clear to me,” said Rothman. “Regardless of what’s reported in press releases or news media, I would expect regulators to rely only on the results of properly designed clinical trials when deciding on Emergency Use Authorizations.”

Dr. Michael Fine, the former Rhode Island Director of Health and the advisor to the House of Representatives' task force on COVID vaccines, says that the AstraZeneca vaccine may need to redo its Phase 3 trials.

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Dr. Michael Fine, PHOTO: GoLocal

“There's been some public discussion of this now, that I think...the AstraZeneca vaccine, they're going have to redo their phase 3 trial and I would like to see them redo it -- and a couple of them,” said Fine.  “As you know, they by mistake sent out a half-dose and tested a couple of thousand people on the half-dose and got better results surprisingly on that group.”

“So they're going to have to test that half-dose for a full Phase 3 trial...because the results they got on the rest of the group were not so good -- they only got about a 60% efficacy rate. I think they need to test it as a three-dose vaccine as well as a two-dose [one] --  we'll see how that all translates but I think what that means is we won't see AstraZeneca in the market until April or May,” said Fine.

 

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FDA PHOTO: Agency

Federal Reviews and Confidence

Opponents are already emerging to the vaccines.

In Oregon, activists, in collaboration with the grassroots organization V is for Vaccine, have planned to partake in an international demonstration to raise public awareness of what they say are vaccine risks, namely for COVID-19 vaccines.

These demonstrations will take place internationally on Monday across Canada, Australia, the U.K. and all of the fifty United States. Sunday marks the busiest travel day of the year in the U.S. and will involve the display of large banners along highway overpasses with the message, “COVID-19 VACCINE MANUFACTURERS ARE EXEMPT FROM LIABILITY.”

V is for Vaccine co-founder Joshua Coleman says the aim of the demonstrations is to spotlight what the group says is the lack of manufacturer liability for injuries and death, both of which can and do occur with vaccines.

"All medical procedures require informed consent. Vaccination is no different, but the reality is vaccines are routinely administered without informing the recipient of severe and acknowledged risks. A fast-tracked COVID-19 vaccine means limited and no long-term safety studies," said Coleman. "With the potential for severe adverse reactions and widespread vaccine mandates, it is critical that people understand their rights, the true scope of risk involved in vaccination and the lack of adequate recourse if they suffer an adverse reaction.”

URI's Rothman questioned the role of non-scientists in the discussion -- and debate. 

“I am confident in the scientists who are responsible for the decisions," said Rothman. "I am concerned about the level and type of involvement of some non-scientists in the normal processes over the past year and what that might indicate for these important decisions.”

He added, ”I have been encouraged by the level of transparency we’ve seen in the vaccine development to date, such as the publishing of clinical trial protocols. There has been so much information available to the public. If this continues, people can become as informed as they wish. However, there’s an awful lot of disinformation as well.”

“I think most people will find it unmanageable and confusing. In my mind, the key is to find reputable sources of information and stick to them. One important point is that people shouldn’t expect to have any reliable data to directly compare one vaccine against another,” he added.

 

When Will Vaccines Be Available

Raimondo announced that she thinks all Rhode Islanders would have access to a vaccine this spring, but that pronouncement seems overly aggressive.

There are concerns that the Raimondo administration should have as little involvement considering the administration's history with program rollouts.

Under Raimondo, the UHIP program was years late, hundreds of millions of dollars over budget, and under federal court oversight. Similarly, the rollout of the technology upgrades for the Division of Motor Vehicles has been plagued by issues.

Raimondo's testing strategy -- and capability -- during the pandemic has also been highly scrutinized.

The U.S. Centers for Disease Control and Prevention (CDC) is scheduled to meet on Tuesday to make determinations about who will be the first to receive the now emerging coronavirus vaccines.

Advisers to the CDC called the emergency meeting to vote on who they recommend should be the first to get a coronavirus vaccine once one is authorized.

While the CDC has the responsibility to review and approve the efficacy and safety of the emerging vaccines, it is the CDC's Advisory Committee for Immunization Practices that determines the distribution strategy and priorities.

 
 

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