FDA Approves Pfizer COVID-19 Vaccine for Those Ages 16 Years and Older

Janet Woodcock, MD

A version of this article was originally published by our sister site, ContagionLive.

The FDA has granted approval to Pfizer-BioNTech for the tandem’s vaccine BNT162b2 (Comirnaty), a month after giving priority review designation to the biologics license application for the 2-dose COVID-19 vaccine.^1,2

This indication is for those individuals aged 16 years and older, the indication for which BNT162b2 was originally granted an emergency use authorization (EUA) in December 2020. Currently, those aged 12 to 15 years will still have access to the vaccine through the EUA, and the administration of a third dose is recommended for certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Janet Woodcock, MD, acting FDA commissioner, said in a statement.¹ “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”

The Pfizer/BioNTech inoculation is a nucleoside-modified messenger RNA (mRNA) vaccine encoded with the SARS-CoV-2 full-length Spike protein glycoprotein. It was selected for continued assessment against 3 other candidates by Pfizer and BioNTech investigators in July 2020 and was granted Fast Track Designation by the FDA around the same time.

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The approval is particularly promising for the multiple sclerosis (MS) population, as some data have implied a potential increased risk of severe infection and hospitalization for those on certain MS disease-modifying therapies (DMTs),³ and that those with MS or neuromyelitis optica spectrum disorder (NMOSD) on some therapies had lower antibody responses to infection.⁴ This news also follows the recent publication of data in the European Journal of Neurology suggesting that the vaccine has an overall safe profile for patients with MS and should be further confirmed in larger, prospective studies.⁵

Those data, published by Itay Lotan, MD, department of neurology, Rabin Medical Center, and colleagues included 262 patients with MS who responded to the group's survey. Patients first answered general demographic and disease-related questions and were then questioned on vaccination status, date of vaccination, presence, early reactions, and type and timing of new or worsening neurological symptoms following the vaccination. The median age of the cohort was 42 years (range, 22-79 years), with 25.2% (n = 66) of participants reporting associated comorbidities. Disease-modifying therapy (DMT) use was reported in 198 participants (75.6%), while 17 participants received treatment with corticosteroids in the month proceeding the first vaccination. A total of 239 participants (91.2% of responders) received the vaccine, 18 (7.5%) of whom received only 1 dose and 221 (92.5%) participants that received both doses.⁵

Following vaccination, 136 participants (56.9%) reported early adverse events (AEs), with pain at the injection site as the most-reported AE by 111 participants (46.4%). Fatigue (38.1%), muscle pain (36.8%), headache (36.8%), chills (29.7%), fever (15.9%), and dizziness (12.6%) rounded out the other AEs. Among the 198 participants who were treated with DMTs, 100 (55.9%) reported AEs. In comparison, 36 of 57 participants (63.2%) who received the vaccine and were not treated with DMTs reported AEs (P = 0.0683). Sixty-nine of 127 participants (54.3%) treated with DMTs who were younger than 55 years of age experienced AEs, while 23 of the 52-patient cohort (44.2%) above 55 years of age on DMTs reported AEs. Notably, no association between the type of DMT and the frequency and type of AEs was found.⁵

Additional research published in Therapeutic Advances in Neurological Disorders characterized humoral immunity in patients with MS who had received Pfizer’s COVID-19 vaccines and were treated with high-efficacy DMT, finding that only cladribine (Mavenclad; EMD Serono) did not impair humoral response.Protective humoral immunity was demonstrated in 46 of 47 (97.9%) of healthy subjects (n = 47) and untreated patients with MS (n = 32). All patients (100%) treated with cladribine (n = 23) developed a high level of antibodies post-COVID-19 vaccination (P <.0001). Notably, cladribine was the only DMT with a 100% protective humoral immunity rate.⁶

This decision by the FDA comes while new cases of the pandemic virus have reached their highest in the US this year and COVID-19 vaccination rates have nearly plateaued. Several experts in virology and vaccinology explained to NeurologyLive’s sister site, Contagion®, that a full FDA approval for a proven COVID-19 vaccine may better public health efforts geared toward curbing the highly transmissible Delta variant of SARS-CoV-2.⁷

As of the week of August 16, the US reportedly had a COVID-19 vaccine surplus of approximately 100 million doses, as Pfizer-BioNTech, Moderna, and Johnson & Johnson developers’ 2020 rush to manufacture now-authorized vaccines was met by a middling national immunization push in 2021. In the same time frame, the country’s 7-day average for new COVID-19 cases has increased 153% from an estimated 60,000 on July 21 to more than 150,000 on August 21. The Δ-variant has been largely to blame for this newest spike in COVID-19 cases, hospitalizations, and deaths. Per the CDC, the now-prominent strain is estimated to be more than 2-fold more contagious than previous SARS-CoV-2 variants, has been linked to more severe illness among unvaccinated persons, and more breakthrough infections in vaccinated persons.⁸

On August 24, 2021, at 7PM ET, NeurologyLive, the Consortium of Multiple Sclerosis Centers, and Can Do MS will be conducting a 90-minute virtual summit where experts in immunology, virology, and neurology discuss infections and MS, the persistence of the SARS-CoV-2 virus, the impact of viral variants, the current vaccine landscape, and DMT guidance in a joint forum tailored for healthcare providers as well as patients and caregivers.

Register for the "COVID-19 and MS Summit – Infections and Immunizations in the Era of COVID-19" broadcast for free below.

REFERENCES
1. FDA Approves First COVID-19 Vaccine. News release. FDA. August 23, 2021. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
2. U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine. News release. Pfizer; BioNTech. July 16, 20121. Accessed August 23, 2021. https://investors.biontech.de/news-releases/news-release-details/us-fda-grants-priority-review-biologics-license-application
3. Spelman T, Forsberg L, McKay K, Glaser A, Hillert J. Increased rate of hospitalisation for COVID-19 among rituximab-treated multiple sclerosis patients: A study of the Swedish multiple sclerosis registry. Mult Scler J. July 2021. doi:10.1177/13524585211026272
4. Louapre C, Ibrahim M, Maillart E, et al. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. Published online August 2, 2021. doi: 10.1136/jnnp-2021-326904
5. Lotan I, Wilf-Yarkoni A, Friedman Y, Stiebel-Kalish H, Steiner I, Hellman MA. Safety of the BNT162b2 COVID-19 vaccine in multiple sclerosis: early experience from a tertiary MS center in Israel. Eur J Neurol. Published online July 21, 2021. doi:10.1111/ene.15028
6. Achiron A, Mandel M, Dreyer-Alster S, et al. Humoral immune response to COVID-19 mRNA vaccine in patients with multiple sclerosis treated with high-efficacy disease-modifying therapies. Ther Adv Neurol Disord. 2021;14: 17562864211012835. doi:10.1177/17562864211012835
7. Kunzmann K. FDA Approves Pfizer-BioNTech COVID-19 Vaccine. ContagionLive. August 23, 2021. Accessed August 23, 2021. https://www.contagionlive.com/view/fda-approves-pfizer-biontech-covid-19-vaccine
8. Delta Variant: What We Know About the Science. CDC. Updated August 19, 2021. Accessed August 23, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html