Infectious Disease Update: June 15, 2022


The FDA VRBPAC votes to recommend mRNA vaccines in youngest children; WHO moves to rename monkeypox; Anthony Fauci is diagnosed with COVID-19; and Pfizer stops recruiting for a Paxlovid trial.

Here is a recap from this week’s biggest infectious news stories.

FDA Vaccine Committee Recommends mRNA Vaccines for Children Under 5

Today, the Food and Drug Administration's (FDA's) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend both the Moderna and Pfizer-BioNTech COVID-19 vaccines for children as young as 6 months old.

To read more about these votes and our coverage on the meeting, go here.

FDA Vaccine Committee Recommends Moderna Vaccine for Children and Adolescents 6 Years Through 17 Years

Yesterday, The Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted to recommend amending the Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine, mRNA-1273, (Spikevax) to include the administration of the primary series to children and adolescents 6 years through 17 years of age.

To read more about these votes and our coverage on the meeting, go here.

WHO is Renaming Monkeypox

The World Health Organization (WHO) plans to rename monkeypox after a letter signed by 30 scientists called for it because it is stigmatizing.

WHO Director-General Tedros Adhanom Ghebreyesus, PhD, tweeted yesterday: "WHO is also working with partners and experts from around the world on changing the name of #monkeypox virus, its clades and the disease it causes. We will make announcements about the new names as soon as possible.”

In a different tweet, he said the WHO’s Emergency Committee under the International Health Regulations will meet next Thursday, “to assess whether this [monkeypox] outbreak represents a public health emergency of international concern.”

Fauci Has COVID-19

The National Institutes of Health announced Anthony S. Fauci, MD, director of the National Institution of Allergy and Infectious Diseases (NIAID) has been diagnosed with COVID-19. Fauci who has been fully vaccinated and given 2 boosters is reported to be experiencing mild symptoms.

Pfizer Stops Recruiting on Paxlovid Trial

Pfizer announced it has ceased enrollment into the EPIC-SR trial due to low rate of hospitalization or death in the standard-risk population, and they will continue to evaluate treatment in populations with high unmet need.

The study initially enrolled 1153 standard-risk individuals who had (1) a confirmed diagnosis of SARS-CoV-2 infection within five days prior to randomization, (2) onset of symptoms within five days of randomization, and (3) at least one characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 and were fully vaccinated against COVID-19 OR no characteristics associated with risk of severe COVID-19 and were unvaccinated, according to Pfizer.

“Results from our Phase 2/3 EPIC-HR and EPIC-SR studies, as well as post-authorization experience, support the efficacy and safety profile for Paxlovid in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status,” Pfizer CEO Albert Bourla, said. “With up to 40-50% of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid.”

To read more from our recent coverage of Paxlovid, go here.

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