Drive through testing site for Covid-19 patients, healthcare worker in full PPE testing young man for R.1 variant

COVID-19 Updates: R.1 Variant Continues to Spread, Pfizer and BioNTech Receive First FDA Emergency Use Authorization for Booster

Drive through testing site for Covid-19 patients, healthcare worker in full PPE testing man for R.1 variant

At least 233 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, September 27, 2021, including at least 4.76 million deaths. Healthcare officials in the United States have reported more than 43.9 million positive COVID-19 cases and approximately 708,000 deaths. Source:

At least 6.13 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 390 million in the United States. Source: GitHub

R.1 variant continues to spread

The new R.1 variant of COVID-19 has now been detected in 35 countries and 47 U.S. states, according to a recent report by Newsweek.

First detected in Japan, the variant contains a mutation that could enable it to bypass the antibody protection present in those who are fully vaccinated.

There have also been 10,567 reported cases of R.1 detected around the world as of Sept. 22. Both the U.S. and Japan lead the world in the number of cases detected with 2,259 and 7,519 infections recorded, respectively, according to the report.

Additionally, data obtained from GISAID, a global science initiative that provides open access to genomic data of influenza viruses, the most recent case detected in the U.S. was on Aug. 6 and represented at least 0.5 percent of all new cases that month.

R.1 contains the W152L mutation in a region of the spike protein that is the target of antibodies that could reduce their effectiveness, according to the Centers for Disease Control and Prevention (CDC).

Want to learn more about COVID-19? Explore essential learning for nurses.

Pfizer and BioNTech receive first FDA emergency use authorization for booster

The U.S. Food and Drug Administration (FDA) has authorized the booster for the Pfizer-BioNTech COVID-19 vaccine for emergency use authorization (EUA) among three patient cohorts:

  • individuals 65 years of age and older,
  • individuals 18-64 years of age at high risk of severe COVID-19, and
  • individuals 18-64 years of age whose frequent institutional or occupational exposure to the virus puts them at high risk of serious complications of COVID-19, including severe COVID-19.

The booster is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series, according to Pfizer and BioNTech officials.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, chairman and chief executive officer at Pfizer, in a prepared statement. “Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved, including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated.”

The FDA reportedly based the approval on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability, and immunogenicity of a booster dose.

A booster dose elicited significantly higher neutralizing antibody titers against the initial virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will reportedly meet to discuss a potential recommendation for the use and rollout of boosters.

Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under an existing supply agreement with the U.S. government that continues through April. The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world.

Under the EUA in the U.S., a third dose of the vaccine was previously authorized for individuals at least 12 years of age who have undergone solid organ transplant or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

This authorization of a third dose for immunocompromised individuals — administered at least 28 days following the second dose — is separate and distinct from the recent booster dose authorization. The third dose for immunocompromised individuals is meant to address the fact that these individuals sometimes do not build enough protection after two doses of the vaccine. In contrast, the booster dose authorization refers to an additional dose of the vaccine that is given to those who have built enough protection after the primary vaccination series, but could have decreased protection over time due to waning of immunity.

Explore the current and historical impact of vaccines in our course, Staying Healthy: Vaccine-Preventable Diseases.

Moderna finds vaccine effective against variants of concern

New findings by Moderna Inc. suggest that the COVID-19 vaccine is highly effective against most circulating variants of concern. The evidence stems in part from a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC) and a recent publication by the U.S. Centers for Disease Control and Prevention (CDC).

Additionally, the company has shared a new analysis of follow-up through one year in the Phase 3 COVE study suggesting a lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after first dose) compared to participants vaccinated last year (median 13 months after first dose).

“It is promising to see clinical and real-world evidence adding to the growing body of data on the effectiveness of the Moderna COVID-19 vaccine,” said Stéphane Bancel, chief executive officer at Moderna, in a prepared statement. “The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection. We hope these findings are helpful as health authorities and regulators continue to assess strategies for ending this pandemic.”

In a prospective cohort study at KPSC, an analysis of 352,878 recipients of two doses of the vaccine matched to 352,878 unvaccinated individuals found an effectiveness of 87% against COVID-19 diagnosis and 96% against COVID-19 hospitalization. The study was conducted during the emergence of the Delta variant, which was identified in 47% of cases in fully vaccinated individuals.

Recent data published by the CDC examined vaccine efficacy across nine states based on 32,867 medical encounters, including 14,636 hospitalizations between June and August, during the time when the Delta variant became predominant in the U.S.

In the analysis, the Moderna COVID-19 vaccine efficacy against COVID-19 urgent care or emergency visit was 92% and 95% against hospitalization at a median of 96 and 106 days, respectively, after vaccination. Across all age groups, vaccine efficacy was reported to be significantly higher among Moderna vaccine recipients than other COVID-19 vaccines.

Analysis of the open-label portion of the Phase 3 COVE Study compared participants initially randomized to receive the vaccine against participants initially randomized to placebo who were crossed over and vaccinated following emergency use.

In the analysis, 88 breakthrough cases occurred in the more recently vaccinated group compared to 162 cases in the group vaccinated last year. The reduction in incidence rates for participants vaccinated more recently compared to participants vaccinated last year was 36%.

A Cox proportional hazards model showed similar results after adjusting for age and risk factors for severe COVID-19; only 19 severe cases were observed. While not significant, there was a numerical trend towards a lower rate of severe cases in the group vaccinated more recently compared to the group vaccinated last year.

The increased risk of breakthrough in this analysis quantifies the impact of waning immunity in the COVE study between the median follow-up time of 8 months and 13 months since first dose, said Moderna officials.

Questions about the vaccine? Learn more about the process of vaccine development in our recent interview with noted virologist Dr. Angela Rasmussen.

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