FDA Responds to The Post & Email’s Questions on Withdrawn Treatments, Vaccine Safety

by Sharon Rondeau

(Jan. 29, 2021) — On Monday the FDA announced it would “limit use” of two types of monoclonal antibodies to fight COVID-19, which some criticized as a decision made without any supporting “clinical data.”

“As we have throughout the COVID-19 pandemic, the U.S. Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind,” the announcements begins. “Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency.” 

“In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments,” the press release continues. 

It further contends:

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today. 

The press release refers to four alternative treatments “that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.”

In the next paragraph, it stresses what it says is the importance of vaccination:

While it’s critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.

Responding to the FDA’s announcement Monday night, Florida Surgeon General Joseph Ladapo stated, “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”

On Tuesday, Florida Gov. Ron DeSantis, who has championed the distribution of monoclonal antibody treatments in his state and nominated Ladapo to his post, gave a press conference objecting to the FDA’s decision on the claim that it was not supported by evidence.

According to Florida Phoenix, however, one of the manufacturers of the antibodies, Regeneron, agreed with the FDA’s decision.

A study published January 1 reports reduced efficacy of both the COVID-19 vaccines and the monoclonal antibody products used successfully to combat “Delta” and other coronavirus variants.

According to Popular Science on Thursday, “The withdrawal of the emergency use authorization does create real problems for COVID treatment. Supplies of sotrovimab, the one remaining monoclonal antibody therapy still known to be effective, are scarce. The antiviral treatment remdesivir, which was previously only used during hospitalization, can now be used in mildly ill patients, but the drug requires three lengthy infusions. Still, health experts support the decision.”

On Tuesday, The Post & Email contacted Chanapa Tantibanchachai, the media representative indicated at the bottom-left of the news release, with the following inquiry:

Based on your statement here:  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

could you direct me to the “data” the FDA used for its decision?

Also, how can the FDA maintain that the vaccines are “safe and effective” with more than 22,000 deaths reported to the VAERS system believed to be attributable to the vaccines?
https://openvaers.com/openvaers/openvaers-deaths

Is Comirnaty available in the United States yet? If not, why not?

Thank you very much.

Sharon Rondeau, Editor
The Post & Email
www.thepostemail.com

“Comirnaty” is the product jointly manufactured by Pfizer and BioNTech which on August 23, 2021 received approval of its Biologics License Application (BLA) from the Department of Health and Human Services (HHS) with certain stipulations. According to the website:

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY^® (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.

Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.

An earlier version of the product, “Pfizer-BioNTech COVID-19 vaccine,” received EUA approval on December 11, 2020 for “individuals 16 years of age and older.”

The preparation has since been approved under EUA for children aged 12-15 and 5-11, respectively.

On Thursday, we received the following reply from Tantibanchachai:

Hi Sharon,

You can find the data in Section 15 of both the fact sheets for health care providers:

• Bamlanivimab and Etesevimab
• REGEN-COV

With regard to the vaccines, our response on background:

FDA and the CDC place a high priority on vaccine safety and are committed to the integrity and credibility of our vaccine safety monitoring and research efforts. There are several systems in place to continually monitor COVID-19 vaccine safety – including the Vaccine Adverse Event Reporting System (VAERS).

As part of FDA and CDC’s multi-system approach to vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” The claim you referenced incorrectly categorizes the VAERS reporting system. In general, a report made to VAERS does not mean that a vaccine, or doses of a vaccine from the same lot, caused the event. If a safety signal is found in VAERS, further studies can be conducted in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same limitations as VAERS and can better assess health risks and possible connections between adverse events and a vaccine. Additional information about VAERS, VSD, and the CISA project are available here. 

VAERS reports are subject to certain limitations. For example, a certain number of reports of serious illnesses or death do occur by chance alone among persons who have been recently vaccinated. Also, VAERS reports often lack important information, such as laboratory results used to help establish a potential association with the vaccine. For all serious events (life-threatening events, hospitalization, disability, death), follow-up with the health care provider and/or the parent or vaccinated individual is attempted in an effort to collect supplemental information on the reports. Reports of adverse events to VAERS following vaccination do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. Further information can be found on CDC’s website: CDC’s Selected Adverse Events Reported After COVID-19 Vaccination.

VAERS is not the only system in place to monitor vaccine safety. The U. S. government, in partnership with health systems, academic centers, and private sector partners, uses multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. These systems include the VSD, Biologics Effectiveness and Safety (BEST) and Medicare claims data.

Further information about COVID-19 vaccine safety surveillance is available here.

Manufacturers of the COVID-19 vaccines submitted pharmacovigilance plans to FDA to monitor the safety of their vaccines. The pharmacovigilance plan for each vaccine includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. These plans also include other activities aimed at monitoring the safety of the vaccines to ensure that any safety concerns are identified and evaluated in a timely manner.

FDA and the CDC are committed to protecting the health of our nation’s citizens from vaccine preventable diseases and ensuring that information about potential serious adverse events are thoroughly investigated using the best available scientific data. We continue to closely monitor all adverse event reports to ensure that any safety concerns are identified and evaluated in a timely manner, and will update the public as more information becomes available.

Please contact HHS regarding Comirnaty distribution.

Chanapa Tantibanchachai, M.S.
Press Officer

Office of Media Affairs
Office of External Affairs
U.S. Food and Drug Administration
Cell: 202-384-2219
chanapa.tantibanchachai@fda.hhs.gov

The Post & Email contacted HHS Public Affairs and as of this writing has received an acknowledgement but not yet a response to our question. There is a sole reference to “Comirnaty” on the HHS website here.