In the waning days of autumn, it appeared that Texas was destined for a dark winter. As recently as December 14, 2020, the Texas Department of State Health Services (DSHS) reported over 1.3 million confirmed cases of Coronavirus Disease 2019 (COVID-19), with an average 13,698 confirmed cases and 191 deaths per day over the preceding week. The surge in cases portended an ill future, with Texas having the 35th most confirmed cases per capita among states and the District of Columbia during the past 7 days. As yet another wave of the pandemic seems poised to wash over the country, the announcement of regulatory approval of a new COVID-19 vaccine brought hope for the holiday season and the new year.
Regulatory Approval of the Pfizer-BioNtech COVID-19 Vaccine
On December 11, 2020, the United States Food & Drug Administration (FDA) issued Pfizer, Inc. and BioNTech SE the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States, to be administered to individuals 16 years of age or older.
Despite the excitement and enthusiasm surrounding the vaccine, the rigorous regulatory process underlying the vaccine’s approval and ongoing monitoring requirements have been less reported, despite their importance in allaying fears concerning the efficacy and safety of the vaccine. As the vaccine is distributed and administered across the state, it is important for Texans to be apprised of these processes, so they can make an informed decision on whether or not to receive the vaccine.
FDA Review and Emergency Use Authorization
The EUA was the result of laborious efforts in both the public and private sectors following the determination of the Secretary of the United States Department of Health and Human Services (HHS) on February 4, 2020, that there was “a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19” (see “Determination of Public Health Emergency“). On the basis of that determination and the underlying authority granted under Section 564(b)(1)(c) of the Federal Food, Drug, and Cosmetic Act, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.
Prior to issuing the EUA to Pfizer and BioNTech, the FDA reviewed the safety and efficacy data from ongoing clinical trials conducted with approximately 44,000 participants. While these trials enrolled participants 12 years of age or older, the FDA’s review of health and safety data for the purposes of the EUA was only for participants 16 years of age or older, which is why the EUA was ultimately limited to this narrower age bracket. The FDA indicated that its review of the clinical trial data did not identify specific health or safety concerns that would preclude the emergency authorization of the vaccine, and the FDA found it “reasonable to believe the [vaccine] may be effective.” For these reasons, the FDA approved the administration of the vaccine to people 16 years of age or older, believing it “reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine.”
In addition to these front-end review processes, the FDA also outlined a number of conditions in the EUA that must be satisfied by Pfizer and BioNTech in order for the vaccine to continue to be approved. These include facility maintenance, drug storage, and drug packing and labeling requirements to ensure the vaccine is safely manufactured, stored, and prepared for administration. There are also ongoing reporting and maintenance obligations imposed on the companies.
The first of these reporting obligations requires Pfizer and BioNTech to report to the Vaccine Adverse Event Reporting System (VAERS) in the event any of the following were to occur to vaccine recipients:
- There is a vaccine administration error, whether or not associated with an adverse event (the full list of adverse events can be found on the VAERS Table of Reportable Events Following Vaccination);
- There is a serious adverse event for a vaccine recipient, whether or not attributed to the vaccination;
- There is a case of Multisystem Inflammatory Syndrome for a vaccine recipient; and
- Pfizer and/or BioNTech receive reports of vaccine recipients subsequently contracting COVID-19 that results in their hospitalization or death.
The companies must also submit Investigational New Drug (IND) application number 19736 periodic safety reports at monthly intervals, which should contain descriptive information concerning the following:
- A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest;
- Newly identified safety concerns in the interval; and
- Actions taken since the last report because of adverse experiences.
As long as these authorization conditions are met by Pfizer and BioNTech and the EUA is not otherwise revoked, the EUA for the vaccine is intended to remain effective until the emergency declaration by the Secretary of HHS is terminated. The FDA will continue to monitor efficacy data related to younger participants in the clinical trial to determine if the EUA will be modified to apply to a broader age demographic. Pfizer also indicated in its December 11, 2020, press release that it and BioNTech would continue to gather data and prepare to file a Biologics License Application with the FDA for full regulatory approval in 2021.
ACIP Review and Recommendation; CDC Director Approval
Following the EUA issued by the FDA, review of the vaccine by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) was the next step in the regulatory approval process for the vaccine. The ACIP held an emergency meeting on December 12, 2020, to vote on whether to recommend the distribution and administration of the vaccine to persons aged 16 years or older, as authorized by the FDA’s EUA. Ultimately, 11 members of the ACIP voted in favor of distributing and administering the vaccine, and the remaining 3 members recused themselves. This recommendation was then submitted to the Director of the CDC, Robert Redfield, M.D., for his final approval.
Dr. Redfield’s sign-off on the vaccine was the final regulatory hurdle for Pfizer and BioNTech to clear. On December 13, 2020, Dr. Redfield announced his acceptance of the ACIP recommendation and his approval of the distribution and administration of the vaccine to people 16 years of age or older, paving the path for the vaccine’s widespread circulation across the United States and Texas.
Vaccine Distribution in Texas
Despite not accepting Operation Warp Speed research funding for its vaccine, Pfizer and BioNtech have nevertheless moved at warp speed in their logistical roll-out and distribution of the vaccine across the country. Circulation of the vaccine across more than 600 locations in all 50 states and the District of Columbia began this week. More than 145 healthcare facilities received the vaccine on December 14, 2020, and an additional 500 facilities are set to receive the vaccine by December 16, 2020. Priority for these initial distributions was given to large healthcare systems and facilities that are able to efficiently store and administer the vaccine.
Texas has been allocated a large portion of the initial doses of the vaccine, with the DSHS announcing that over 224,250 doses of the vaccine had been earmarked for the Lone Star State during the first week of distributions.
Initial Allocations of the Vaccine in Texas
Thus far, the circulation of the vaccine has been proceeding according to schedule. The first shipments of the vaccine were delivered to the state at the beginning of this week, and the DSHS announced its plan to ship the vaccine to approximately 110 health facilities during the initial week of distributions.
On December 14, 2020, the first four facilities to receive the vaccine were UT Health San Antonio, Methodist Dallas Medical Center, UT Health Austin Dell Medical School, and MD Anderson Cancer Center, with an additional 19 facilities receiving the vaccine on December 15, 2020. The remaining facilities will receive the vaccine over the remainder of the week.
The full list of week 1 allocations of the vaccine across Texas is available on the DSHS website.
Priority Recipients of the Vaccine in Texas
The COVID-19 Vaccination Plan issued by the DSHS on October 16, 2020 remains the Texas position on vaccine distribution. The top priority under the plan is healthcare workers, with the next emphasis placed on individuals identified by the CDC as being the most vulnerable subset of workers during the pandemic, including frontline workers, first responders, and the personnel for long-term care facilities, as well as the people noted by the CDC to be at increased risk of severe illness if diagnosed with COVID-19 (i.e., people with underlying medical conditions and people 65 years of age and older).
Texas’ supply of the vaccine is expected to increase markedly over the coming weeks as subsequent allocation amounts are determined, though Governor Greg Abbott has previously stated that the CDC has slated for Texas to receive approximately 1.4 million doses of the vaccine by the end of the year (though proper administration of the vaccine ultimately requires each individual to receive two doses). Despite these projections and goals, the DSHS has reiterated that taking the vaccine will be voluntary and that no individuals will be required by the state to receive the vaccine.
Data collection will also be significant to ensure both the private and public sectors remain up to date on the efficacy and adverse trends in the administration of the vaccine. The DSHS has indicated that the Texas Immunization Registry (known as ImmTrac2) will be used to collect data from healthcare providers on the administration of the vaccine, and vaccine dosage data will also be received from providers through the CDC Immunization Gateway Interface in connection with chain pharmacies directly enrolled by the CDC. However, in accordance with laws governing the Texas Immunization Registry under Texas Health and Safety Code Section 161.0073, no individualized data or other personally identifiable data of Texas patients will be shared via the CDC Immunization Gateway. Instead, the DSHS will directly provide the CDC with aggregate anonymized data regarding vaccine doses that have been administered. General vaccine data will also continue to be updated and publicly available on the DSHS website.
Subsequent Phases of the Vaccine Rollout
In anticipation of increased quantities of the vaccine (as well as any other vaccines approved by regulators, such as the impending Moderna vaccine), the DSHS has indicated that it will continue to prioritize two key objectives when helping to shepherd the broader administration of the vaccine: providing equitable access to the vaccine for all vulnerable and frontline populations, and ensuring high utilization of the vaccine within specific, at-risk populations.
To achieve these goals, the DSHS has reiterated its plan to integrate the administration of the vaccine through public and private partnerships and, eventually, make the vaccine widely available through routine vaccination programs. Despite general projections anticipating the widespread availability of the vaccine, Governor Abbott’s office has emphasized that it will continue adhering to its allocation criteria promoting the protection of healthcare and frontline workers, protecting vulnerable populations and mitigating health inequities, using data-driven allocations that remain cognizant of geographic diversity, and maintaining transparency throughout the entire process.
Paving the Path to the Future
Despite the quagmire that COVID-19 has proven to be, there is hope on the horizon. The preliminary groundwork and logistics for administering the first doses of the vaccine are tilling the soil for more expansive distribution and administration of the vaccine. Initial distribution and administration of the vaccine across facilities in Texas is proceeding according to schedule, though the efficacy of the vaccine and its administration across medical centers will continue to be monitored.
As Dr. Mark Casanova, President of the Dallas County Medical Society, aptly said, “[I]t’s still important for people to continue wearing masks, washing their hands, and watching their [social] distance…but at least there is light at the end of the tunnel.”
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