As far more than the usual suspects are working in overdrive to make folks scared of the COVID-19 vaccines being developed, there are a lot of reasons to be confident they will be safe and effective.
A COVID-19 vaccine will not be rushed and approved for political reasons.
Reasons to Be Confident in a COVID-19 Vaccine
For one thing, there are many experts watching the process who will make sure that any vaccine that gets approved either has rigorous safety and efficacy data to support that approval, or they will let us know about it.
For another, however much the CDC, FDA, and HHS have gotten politicized lately, there are still many people in important positions, career workers who aren’t appointed by the administration in power, who will not let an unsafe or ineffective vaccine reach us.
“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective. I’m not concerned about political pressure.”Anthony Fauci on Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming
And then there is simply the way in which a COVID-19 vaccine will have to get approved, both in the US and globally.
“EMA has been, as of 30 July 2020, in discussion with developers of 38 potential COVID-19 vaccines. However, the EMA estimates that it might take at least until the beginning of 2021 before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use in the EU/EEA .”Vaccines and treatment of COVID-19
It may surprise some people, but approving a new vaccine is not something that is done just by the head of the CDC or FDA.
How the Covid-19 Vaccine Will Get Approved
Typically, the 15 voting members of the Vaccines and Related Biological Products Advisory Committee would review and evaluate “data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility.”
In the case of the COVID-19 vaccines, the FDA created an additional independent data safety monitoring board (DSMB) to help with this evaluation.
“Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.”Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming
This COVID-19 vaccine DSMB is being chaired by Rich Whitley, MD, a past president of the Infectious Diseases Society of America (IDSA).
“We expect nothing less from FDA moving forward. It is essential that FDA maintain its scientific independence, adhere to required standards and protocols, and as you have repeatedly and recently promised, make decisions “based solely on good science and data.” Should political pressure arise, we believe it is your duty to the American people to notify Congress and the American people. Any political involvement in a future vaccine or treatment threatens to undermine the credibility of the agency, and public confidence in vaccines and treatments approved for use by FDA.”Lawmakers call on FDA to ensure science, not politics, guides COVID-19 vaccine approval process
Of course, the COVID-19 vaccine DSMB isn’t the final word on the COVID-19 vaccines…
“Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA’s Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.”Unwavering Regulatory Safeguards for COVID-19 Vaccines
The COVID-19 vaccine DSMB and the Vaccines and Related Biological Products Advisory Committee both present their findings to Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
“The discussion then turned to concerns about a so-called October surprise announcement, in which the Trump administration rushes to unveil a vaccine candidate, the sources said. At that point, they said, Marks told participants on the call that if the FDA were pressured to approve a vaccine without enough evidence of it being safe and effective, he would resign.”Exclusive: Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
And then once a COVID-19 vaccine is approved by the FDA, the Advisory Committee on Immunization Practices (ACIP) and the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus will provide recommendations on who gets them.
Will any of that happen at these upcoming meetings?
- September 22, 2020 – ACIP Meeting
- October 22, 2020 – the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.
- October 28-29, 2020 – ACIP Meeting
Almost certainly not.
Few experts think that a COVID-19 vaccine will be available before the end of the year.
“While the pace of COVID-19 vaccine R&D has been unprecedented—with many candidates now in advanced stages of clinical development—more robust clinical data are still needed. The most advanced candidates are expected to begin reporting data from pivotal phase III studies in the coming months. The safety and efficacy data from these studies will inform regulatory decisions on whether to make vaccine candidates available for broader use.”321 vaccine candidates against COVID-19 now in development
But when it is finally approved, you can be confident that it will be safe and effective.
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”COVID-19 Vaccine Manufacturers Safety Pledge
I know I am.
More on COVID-19 Vaccine Confidence
- Vaccine Testing and Development Timeline and Myths
- COVID-19 Vaccine Challenges
- COVID-19 Vaccine Update
- About That Russian COVID-19 Vaccine…
- Understanding COVID-19 Misinformation
- QAnon Vaccine Conspiracy Theories
- Can Vaccines Alter Your DNA?
- How To Counter Vaccine Hesitancy
- COVID-19 Vaccine Manufacturers Safety Pledge
- Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming
- Lawmakers call on FDA to ensure science, not politics, guides COVID-19 vaccine approval process
- Infectious Diseases Specialists to FDA: Don’t Cut Corners in COVID-19 Vaccine Approval
- NIH – Data and Safety Monitoring Board (DSMB)
- FDA – Vaccines and Related Biological Products Advisory Committee
- FDA – Vaccine Product Approval Process
- FDA – Development and Licensure of Vaccines to Prevent COVID-19
- Meet the most important federal official you probably don’t know — the man who holds the fate of the coronavirus vaccine in his hands
- Meet FDA’s Peter Marks, ‘the single most critical figure in the [Covid-19] vaccine decision’
- Exclusive: Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
- Dr. Whitley named chair of Data and Safety Monitoring Board for COVID-19 vaccines
- ACIP Presentation Slides: August 2020 Meeting
- ACIP Presentation Slides: July 2020 Meeting
- ACIP Presentation Slides: June 2020 Meeting
- A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus
- Unwavering Regulatory Safeguards for COVID-19 Vaccines
- CDC – The Vaccine Life Cycle: Safety at Every Phase
- ECDC – Vaccines and treatment of COVID-19
- A Top Vaccine Expert Answers Important Questions About a COVID-19 Vaccine
- COVID-19 Prevention Network
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
- COVAX: Ensuring global equitable access to COVID-19 vaccines
- Public sentiments and emotions around COVID-19
- Social solidarity and widespread public trust needed to boost vaccine confidence during COVID-19
- Enhancing Public Trust and Health with COVID-19 Vaccination
- Co-Chairs’ Statement: Vaccine Confidence, Social Media Misinformation, and National Security within the Covid-19 Crisis
- Strengthening Vaccine Confidence in Family Practice Offices During the COVID-19 Pandemic
- COVID-19 vaccine tracker
- WHO – Draft landscape of COVID-19 candidate vaccines
- 321 vaccine candidates against COVID-19 now in development
- The latest in the COVID-19 vaccine race