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vaccination

COVID-19 Roundup: Vaccine Warning, Variants, Viral Clearance, Booster Doses

Johnson & Johnson Vaccine Warning1

The US Food and Drug Administration has updated their COVID-19 Vaccine fact sheets to include a warning on the increased risk of Guillan-Barré Syndrome (GBS) following vaccination with the Johnson & Johnson (Janssen) vaccine.

Of the estimated 12.5 million doses administered of this vaccine, 100 preliminary reports of GBS have been reported using the Vaccine Adverse Event Reporting System (VAERS). Serious cases that required hospitalization occurred in 95 of the 100 reports, resulting in 1 death.

Certain vaccines, such as specific seasonal influenza vaccines and a vaccine to prevent shingles have also been associated with an increased risk of GBS.

“Although the available evidence suggests an association between the Janssen vaccine and an increased risk of GBS, it is insufficient to establish a causal relationship,” the update concluded. “No similar signal has been identified with the Moderna and Pfizer BioNTech COVID-19 vaccines. FDA continues to work with its partner in vaccine safety surveillance, the CDC, to monitor reports of GBS following vaccination with the Janssen COVID-19 vaccine. Importantly, the FDA has evaluated the available information for the Janssen COVID-19 vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.”

Infection by Multiple Variant Strains2

A 90-year-old woman in Belguim has died after becoming infected with two strains of the SARS-CoV-2 virus, according to a paper presented at the 2021 European Congress of Clinical Microbiology & Infectious Diseases.

After routine screening for the presence of variants, the researchers found variant signals of spike protein substitutions for the alpha (B.1.1.7, also known as the United Kingdom strain) and beta (B.1.351, also known as the South Africa strain) strains. The results were confirmed the analysis of a second sample.

Remdesivir, Hydroxychloroquine, and Viral Clearance3

The viral clearance of COVID-19 in hospitalized patients was not affected by either remdesivir or hydroxychloroquine (HCQ), according to the results of a recent randomized controlled trial.

As an add-on to the World Health Organization’s Solidarity Trial, the researchers examined the effect of the two medications on all-cause in-hospital mortality, respiratory failure severity, inflammation variables, and viral clearance in the oropharynx.

Included were 181 patients with COVID-19 who were admitted to 1 of 23 hospitals in Norway from March 2020 to October 2020. Patients were randomly assigned to receive remdesivir (n = 42), HCQ (n = 52), or standard of care (n = 87).

While there was a significant decrease in the SARS-CoV-2 load in the oropharynx during the first week, all 3 groups had similar decreases and 10-day viral loads. The degree of respiratory failure and inflammatory variables in plasma or serum were not affected by remdesivir and HCQ. In addition, symptom duration, level of viral load, degree of inflammation, and presence of antibodies at hospital admittance was not associated with the lack of antiviral effect.

COVID-19 Vaccine Booster Not Currently Necessary4

The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have released a joint statement that booster doses for the COVID-19 vaccines are not necessary at this time.

The joint statement comes in response to BioNTech’s recent announcement of plans to ask health officials to authorize a booster dose for the Pfizer COVID-19 vaccine.

“FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the statement concludes. “This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

 

 

References:

  1. Coronavirus (COVID-19) Update: July 13, 2021. News release. FDA; July 13, 2021. Accessed July 16, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021
  2. Vankeerberghen A, Holderbeke A, Boel A, et al. Case report: a 90-year-old lady infected with two COVID-19 VoCs: 201/501Y.V1 and 20H/501Y.V2. Paper presented at: European Congress of Clinical Microbiology & Infectious Diseases; July 9-12, 2021. Accessed July 16, 2021. https://www.olvz.be/sites/default/files/2021-07/04978-90_year_old_double_infection.pdf 
  3. Barratt-Due A, Olsen IC, Nezvalova-Henriksen K, et al. Evaluation of the effects of remdesivir and hydroxychloroquine on viral clearance in COVID-19. ACP. Published online July 13, 2021. doi: 10.7326/M21-0653
  4. Joint CDC and FDA statement on vaccine boosters. News release. HHS; July 8, 2021. Accessed July 16, 2021. https://www.hhs.gov/about/news/2021/07/08/joint-cdc-and-fda-statement-vaccine-boosters.html