Contagion Editorial Team

FDA Authorizes Expansion for EUAs for mRNA Vaccines for Children as Young as 6 Months

Today, the US Food and Drug Administration (FDA) 

 the Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccine for children as young as 6 months old. This news comes just 2 days after the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend amending the EUA of the Pfizer-BioNTech vaccine for children 6 months through 5 years of age, and the Moderna vaccine for children 6 months through 5 years of age.

Moderna Will Study COVID-19 Vaccine for Babies

Moderna is planning to study its vaccine in babies 3 months to 6 months old, according to 

. The study is being named BabyCove and is expected to begin recruiting in September and will include up to 700 babies.

Florida Not Ordering COVID-19 Vaccines for Children

The State of Florida is not planning on stocking mRNA vaccines for young children, even after the news the Pfizer and Moderna vaccines were authorized today.

At a press conference yesterday, Florida Governor Ron DeSantis explained the state’s policy and beliefs on vaccines in the youngest pediatric population.

“I would say we are affirmatively against the COVID vaccine for young kids,” DeSantis said. “These are the people who have zero risk of getting anything.”

“To do an emergency-use authorization for a six month old or a one year old simply to placate anxiety, that’s not the standard when you’re doing this,” he stated inthe same press conference.

GSK Announces its Phase 3 Study for its RSV Vaccine for Seniors

GSK reported its investigational respiratory syncytial virus (RSV) vaccine demonstrated it was “statistically significant and clinically meaningful efficacy in adults aged 60 years and above.”

This result comes from its AReSVi 006 phase 3 trial, which is a randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA vaccine in individuals aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. 

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This past week has been extremely busy in infectious disease with a lot of vaccine news that could impact young children. In addition, GSK reported on its phase 3 study on its RSV vaccine for seniors.

Infectious Disease Update: June 17, 2022


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 

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.

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.”

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 

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.

Infectious Disease Update: June 15, 2022

The Food and Drug Administration (FDA) has approved GSK’s measles, mumps and rubella (MMR) vaccine, Priorix, for individuals 12 months of age and older.

“We’re proud to make Priorix available in the US for the first time, adding a choice for providers to help protect patients against these highly-contagious diseases and to further strengthen offerings in our pediatric vaccine portfolio,” Judy Stewart, senior vice president and head of US Vaccines, GSK, said.

The GSK vaccine was studied in 6 clinical trials, in which a total of 12,151 participants (6391 in the US) received at least 1 dose of Priorix: 8780 children (4148 in the US) 12 through 15 months of age; 2917 children (1950 in the US) 4 through 6 years of age; and 454 adults and children (293 in the US) 7 years of age and older. The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness and fever. The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine.

The Centers for Disease Control and Prevention (CDC) recommends children get 2 doses of the MMR vaccine beginning with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age.

Priorix currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand.

The GSK MMR vaccine is scheduled to be on CDC Advisory Committee on Immunization Practices (ACIP) meeting agenda this month for consideration of formal inclusion into the vaccine schedule and recommendations.

GSK’s Priorix MMR vaccine received the federal agency’s approval which was based from data of 6 clinical trials evaluating its safety.

FDA Approves MMR Vaccine for Individuals 12 months of Age and Older

In a White House press briefing this afternoon, President Joe Biden’s Coronavirus Response Coordinator, Ashish Jha, MD, said COVID-19 vaccines for children under 5 years of age might be available as early as June 21.

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee will be meeting on June 14-15 to discuss the Moderna and Pfizer vaccines for these pediatric populations.

“On June 15, 2022, under Topic II, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age,” The FDA stated on its website.

Jha believes post-meeting, a decision will be made quickly on the recommendation to authorize the vaccines.

"We expect an FDA decision shortly after the advisory committee meeting, and we look forward to this process playing out," Jha said during the briefing.

He said the United States has enough supplies of the Moderna and Pfizer vaccines and ready to ship if the federal regulatory agencies authorize the mRNA vaccines.

The White House coronavirus response coordinator said vaccines for children under 5 could potentially begin on June 21.

White House Official: COVID-19 Vaccine May be Available to Youngest Children Later This Month

The Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription for people with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer  multi-analyte COVID-19 test authorized by FDA. 

This is a non-prescription test that people can self-collect a nasal swab sample at home and then send that sample to Labcorp for testing. The test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, respiratory syncytial virus (RSV), along with SARS-CoV-2. 

“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a statement. 

Test results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results. This home sample collection kit can be purchased online or in a store. 

The samples can be self-collected by individuals ages 18 years and older, self-collected by individuals 14 years and older with adult supervision, or collected with adult assistance for individuals 2 years and older. 

“The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home,” Shuren said.

This is the first test authorized for all 3 viruses and is over the counter.   

FDA Authorizes COVID-19 Test That Also Detects Influenza, RSV


Another week has gone by and here is an opportunity to catch-up with some of the important stories we have been covering this week.

 compiles 5 highlights of our coverage in infectious disease including video interviews, podcasts, and significant stories from the week ending April 8, 2022.



Here are Contagion’s highlights from the week:

1. 

FDA Vaccine Committee Discusses the Future of COVID-19 Boosters


The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met today to discuss how to proceed with informing future COVID-19 vaccine strain composition and booster decisions.

How Rapidly Did Hospitals Adopt COVID-19 Recommended Procedures?


 Notoriously slow to implement new practices, most hospitals rapidly updated their standard treatment procedures during the COVID-19 pandemic.

Vaccine-Adverse People Commonly Faced Childhood Adversity


A new study found people who staunchly oppose COVID-19 vaccines were more likely to have experienced adverse childhoods, making them distrustful from a young age.

Second Booster Dose Demonstrates Limited Protection Against Infection


New data coming from Israel shows the Pfizer-BioNTech COVID-19 vaccine did offer some protection initially, but waning immunity occurs rapidly.

The HealthCare-Associated Infection Risk Hiding in Plain Sight


A recent study showed that 25% of mattresses within 4 hospitals required complete replacement, underlying a serious health risk that could lead to unnecessary infections.

Here is a rundown of the most popular stories we covered this past week.

Contagion Editorial Team

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