A CLOSER LOOK: COVID-19 vaccine hesitancy, myths & FDA approval

A Closer Look

76 COVID-19-related deaths in 72 hours, per ADH

Vials with covid-19 coronavirus vaccine on laboratory table ready to be distributed for prevention of infection with this virus. Getty Images.

ARKANSAS (KNWA/KFTA) — The current COVID-19 vaccines used in the United States are authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), but not directly by the FDA — this is one reason some Arkansans aren’t getting the shot, below are some other reasons.

COVID-19 vaccine myths, per the American Academy of Family Physicians:

  • The vaccines were developed too fast to be safe: The technology used to develop the new mRNA COVID-19 vaccines isn’t new. It’s been studied and used for cancer research, and the original research on messenger RNA (mRNA) vaccines is decades old. The other vaccine platform uses a weakened adenovirus, which has been studied extensively for other vaccines.
  • There weren’t enough clinical trial participants to declare the vaccines safe: This is false. The authorized COVID-19 vaccines enrolled tens of thousands of participants, They were followed for two months after receiving the second dose, which is common with vaccine trials.
  • I already had COVID-19, so I don’t need the vaccine: It’s not clear how long a natural infection with COVID-19 provides immunity from the disease. There are reports of individuals being reinfected with the virus, even after being very ill with COVID-19. The CDC recommends that a recovering COVID-19 patient get the COVID-19 vaccine 90 days after being infected.
  • The vaccine will alter my DNA: This isn’t possible. mRNA vaccines work in the cell’s cytoplasm and never enter the cell nucleus, where the DNA, your genetic material, lives. It’s broken down quickly once it enters the cell and delivers the needed vaccine “message” to the cell’s machinery. The virus spike protein is also rapidly broken down once there is no longer any mRNA. The adenovirus platform uses DNA encoding the spike protein which does enter the nucleus.
  • COVID-19 vaccines will deliver a microchip into my body: There is not a microchip in the vaccines. This false rumor started after comments about digital vaccine records. State electronic immunization records help patients and physicians track vaccines they have received. There are no electronic components in the vaccines. The mRNA, lipids (fat bubble), salts and other stabilizing agents are routinely used in other medicines.
  • I won’t need to wear a mask after I’m vaccinated: Wear your mask, wash your hands and maintain physical distance until more is known and more people have been vaccinated. The COVID-19 vaccines protect you from getting seriously ill. But it’s not known if the vaccine will keep you from being infected and transmitting the virus to others.
  • I only need one dose of the vaccine to be protected against COVID-19: There isn’t enough data to support changing the COVID-19 vaccine dosing recommendations. While the COVID-19 vaccine developed with the adenovirus platform is given in one dose, you should get two doses of the mRNA vaccines to achieve the best level of immunity and protection.
  • I should wait for the vaccine that is more effective. All COVID-19 vaccines are safe and effective options. There is no preference. The goal is to get everyone vaccinated, so it’s important to take the vaccine that is offered to you.

FDA drug 12-step approval process, 4 phases

Drug sponsor’s discovery and screening phase: Sponsor develops a new drug and seeks FDA approval for sale in the U.S. 1. Sponsor tests drug on animals for toxicity. 2. The sponsor submits an Investigational New Drug (IND) application to the DFDA based on testing results. This includes the drug’s composition, manufacturing and develops a plant for human testing.

Drug sponsor’s clinical studies/trials: 3. Phase 1, 20-80 is the typical number of healthy volunteers use. The goal is to determine what the drug’s most request side effects are and, often, how the drug is metabolized and excreted. 4. Phase 2, 100’s. The typical number of patients used and it’s to emphasize effectiveness. The goal is to get preliminary data if the drug works in people who have a certain disease or condition. Safety continues to be evaluated and short-term side-effects are studied. 5. Phase 3, 1000’s is the typical number of patients used in this phase. The studies gather more information about safety and effectiveness, study different populations and dosages, and uses the drug in combination with other drugs.

FDA’s New Drug Application (NDA) review: 6. Review meeting. The FDA meets with a drug sponsor before submission of an NDA. 7. NDA application: The drug sponsor formally asks FDA to approve a drug for marketing in the U.S. by submitting an NDA. The NDA includes all animal/human data, how the drug behaves in the body, and how it is manufactured. 8-9. Application reviewed: After the NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, the FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness. 10. Drug labeling: The FDA reviews the drug’s professional labeling and assures appropriate information is communicated to health care professionals and consumers. 11. Facility inspection: The FDA inspects the facility where the drug will be manufactured. 12. FDA drug approval: The FDA reviewers will approve the application or issues a response letter.

The FDA’s post-approval risk assessment systems. This is Phase 4, once the FDA approves a drug, the post-marketing monitoring state begins. The sponsor (usually the manufacturer) is required to submit periodic safety updates to the FDA.

FDA’s COVID-19 vaccine EUAs approval timeline

Pfizer-BioNTech and Moderna have submitted for full FDA approval and Janssen is expected to follow.

Each vaccine is unique when it comes to the review process for FDA approval. The top priority is that the vaccine is safe and effective, according to the FDA, and is “critical to ensuring that the FDA’s rigorous standards are met.”

For the vaccines to get FDA approval may help regarding vaccine hesitancy, but that is not expected for months, according to FDA statements to media outlets.

Pfizer has announcedExternal Link Disclaimer, the FDA has formally accepted the company’s Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older and has granted the application priority review. Currently, the vaccine is authorized for emergency use to prevent COVID-19 in individuals ages 12 and older. The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time. Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date. 

FDA July 16 COVID-19 update

COVID-19 AND THE CDC

Some fully vaccinated people are getting sick or may have mild COVID-19 symptoms, and the shot helps reduce the severity of the disease, according to the Centers for Disease Control (CDC).

Last week, CDC Director Dr. Rochelle Walensky said “we feel like we have to act” when she announced revised guidelines for wearing masks: fully vaccinated people should wear a mask in certain settings and (everyone) in K-12 schools.

“This weighs heavily on me,” said Dr. Walensky. “People are tired, frustrated, [there are] mental health challenges … it’s is not a welcome piece of news that masking is going to be a part of life after getting vaccinated.”

The CDC recommended getting vaccinated before COVID-19 mutates, should that happen then this current set of vaccines may not be as effective in protecting people.

The Kaiser Family Foundation (KFF) looked at websites and official state sources of all 50 states and D.C. for data on the COVID-19 breakthrough cases — those are cases where fully vaccinated people get infected, and some are hospitalized or have died, which is known to happen since vaccines are not 100% effective. Here are some discoveries by KFF.

  • The CDC reported as of July 19, 2021, of 5,601 hospitalized breakthrough cases, 27% were asymptomatic or not related to COVID-19. Of 1,141 fatal cases, 26% were asymptomatic or not related to COVID-19.
  • Twenty-five states reported some data breakthrough cases, 19 on hospitalizations and deaths.
  • Fifteen states regularly updated data usually on a weekly basis.
  • Data from the 15 states indicated breakthrough cases, hospitalizations, and deaths are extremely rare among those who are fully COVID-19 vaccinated.
  • Arkansas’ hospitalization rate among fully vaccinated people with COVID-19 was .06% (note: hospitalization may or may not have been dued to COVID-19).
  • Arkansas’ death rates among fully vaccinated people was .01%. (note: hospitalizatoin may or may not have been due to COVID-19).
NOTE: *Where states did not specify the start of their collection periods of COVID-19 breakthrough event data, we assumed start date of January 1, 2021. **In some cases, it is not possible to determine whether hospitalization or death of a vaccinated individual with COVID-19 was due to COVID-19. States that are greyed out either do not provide COVID-19 breakthrough data or have not collected data for longer than one month, such as in the case of SC. “N/A” refers to data that is either not applicable (for states not reporting breakthrough data) or missing data. Many states only include data on state residents. For some states, breakthrough data after May 1, 2021, only includes data on breakthrough hospitalizations and deaths. For AR, data was obtained through personal communication with state officials. Hospitalization data were not available for the full observation period of AR’s data, thus, the previous week’s hospitalization totals were used to estimate the last week of missing data.SOURCE: KFF analysis of State-Level Data; Johns Hopkins University; U.S. Department of Health and Human Services.

In Arkansas, there are 587 COVID-19 pediatric new cases from Friday, July 30 to Monday, August 2. People between the ages of 25 to 34 have the most cases at 860, according to the ADH.

Statewide, the Hospital Association shows a total of 416 COVID-19 patients in ICU, and 43% are in the Metro region (Pulaski County). Overall, the Metro region has the most COVID-19 admissions (381) with 181 in ICU and 105 patients on ventilators.

ADH map.

Arkansas has 7 hospital regions, here are the COVID-19 numbers, per the ADH website.

SOUTHEAST

Total Staff Bed Capacity: 452
Max Flex Bed Capacity: 592
COVID-19 Positive Admissions: 54
COVID-19 Positive Admissions in ICU: 15
COVID-19 Positive Admissions on Ventilators: 4

SOUTHWEST

Total Staff Bed Capacity: 1,137
Max Flex Bed Capacity: 1,078
COVID-19 Positive Admissions: 180
COVID-19 Positive Admissions in ICU: 64
COVID-19 Positive Admissions on Ventilators: 35

METRO

Total Staff Bed Capacity: 3,304
Max Flex Bed Capacity: 4,368
COVID-19 Positive Admissions: 381
COVID-19 Positive Admissions in ICU: 181
COVID-19 Positive Admissions on Ventilators: 105

NORTHEAST

Total Staff Bed Capacity: 1,002
Max Flex Bed Capacity: 1,504
COVID-19 Positive Admissions: 134
COVID-19 Positive Admissions in ICU: 38
COVID-19 Positive Admissions on Ventilators: 20

NORTH CENTRAL

Total Staff Bed Capacity: 580
Max Flex Bed Capacity: 865
COVID-19 Positive Admissions: 111
COVID-19 Positive Admissions in ICU: 23
COVID-19 Positive Admissions on Ventilators: 11

ARKANSAS VALLEY

Total Staff Bed Capacity: 1,175
Max Flex Bed Capacity: 1,388
COVID-19 Positive Admissions: 98
COVID-19 Positive Admissions in ICU: 27
COVID-19 Positive Admissions on Ventilators: 18

NORTHWEST

Total Staff Bed Capacity: 1,187
Max Flex Bed Capacity: 1,627
COVID-19 Positive Admissions: 181
COVID-19 Positive Admissions in ICU: 68
COVID-19 Positive Admissions on Ventilators: 42

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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