. Prior to joining MJH Life Sciences in 2020, he has covered a variety of fields and markets including diabetes, oncology, ophthalmology, IT, travel, and local news. You can email him at 

John Parkinson

Although it is hard to believe those of us in the northern hemisphere are going to be eligible for next season’s influenza vaccines in 3 months, it is important to recognize the work being done in this area of medicine.

Earlier this year, the World Health Organization (WHO) recommended that quadrivalent vaccines for use in the 2022-2023 influenza season in the northern hemisphere contain the following:

an A/Victoria/2570/2019 (H1N1)pdm09-like virus;

a B/Austria/1359417/2021 (B/Victoria lineage)-like virus; and

a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

Cell culture- or recombinant-based vaccines

an A/Wisconsin/588/2019 (H1N1)pdm09-like virus;

In addition, the WHO recommends that trivalent vaccines for use in the 2022-2023 influenza season in the northern hemisphere contain the following:

an A/Darwin/9/2021 (H3N2)-like virus; and

a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

an A/Darwin/6/2021 (H3N2)-like virus; and

a B/Austria/1359417/2021 (B/Victoria lineage)-like virus

The Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to support the WHO's recommendations.

In looking to address influenza, pharmaceutical companies are developing vaccines for specific age groups and creating combination vaccines to address multiple viruses.

Just last week the Food and Drug Administration’s (FDA) Advisory Committee on Immunization Practices (ACIP) granted preferential recommendation for differentiated influenza vaccines for adults 65 years and older.

Another area of interest is companies studying combination vaccines that include addressing more than just influenza. For example, SARS-Co-V2, and respiratory syncytial virus (RSV) are both being included in some manufacturers' plans for vaccine development.

Sanofi Fluzone High-Dose Quadrivalent influenza vaccine. 

 recently spoke to Sanofi Medical Director Christopher Rizzo, MD, on why there is a need for a high-dose influenza vaccine for seniors, and what it means to have 

 to receive ACIP’s preferential recommendation.

Moderna’s various influenza and combination vaccines.

Earlier this month, Moderna reported it had started dosing participants in its phase 3 study for it influenza vaccine candidate, MRNA-1010.

 at the end of March, Moderna announced developments of its new vaccine programs and reviewed data. The company is utilizing its mRNA technology platform for multiple disease states, and have investigational vaccines in various phases of development and study.

Moderna is developing its mRNA-1230 vaccine to cover SARS-CoV-2, influenza, and RSV.

Novavax COVID-19 Influenza Combination Vaccine. 

 combines the company’s COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The preliminary trial results found that various vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.

"We're encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19," Novavax President of Research and Development Gregory M. Glenn, MD, said in a statement.

 The FDA granted an Emergency Use Authorization (EUA) to the 

Labcorp Seasonal Respiratory Virus RT-PCR DTC Test

 to detect COVID-19, influenza, and RSV back in May. This is the first test authorized for all 3 viruses and is over the counter.




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With the impending start to the 2022-2023 influenza season just a few months away, here is some information on what is being studied for vaccines as well as recommendations and new testing.

Influenza Vaccine Update: What Can We Expect This Immunization Season?

According to the World Health Organization (WHO), there are an estimated 296 million people worldwide who have chronic hepatitis B (CHB). This disease can lead to liver complications including cirrhosis and liver cancer, which results in nearly 900,000 deaths per year.

Currently, viral suppression is the goal for clinical outcomes. However, viral replicative activity may return if treatment is stopped, so ongoing, lifelong therapy is required to prevent viral rebound. Right now only a limited number of patients currently treated for CHB achieve reduced levels of hepatitis B surface antigen (HBsAg) loss, which is considered the hallmark for achieving a functional cure. 

GSK’s investigational therapy bepirovirsen (GSK3228836) recently reported results from its phase 2B clinical trial which demonstrated it reduced HBsAg levels and hepatitis B virus (HBV) DNA after 24 weeks of treatment in people with CHB.

“Specifically, the reduction in hepatitis B surface antigen and HBV DNA to below the lower limit of quantification has the potential to be clinically meaningful and lead to functional cure. This could help people living with CHB and healthcare providers manage the long-term consequences of CHB which include the social burden as well as the risk of developing life-threatening liver complications,” Professor Man-Fung Yuen, MD, PhD, principal Investigator and chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, The University of Hong Kong, said.

According to GSK, bepirovirsen is a antisense oligonucleotide (ASO) designed to specifically recognise the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens, which facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver’s own enzymes to eliminate the RNA by digesting it to an inactive form. 

The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has an additional property of stimulating immune responses via Toll-like receptor 8 (TLR8) which may help the immune system to achieve durable clearance of the virus from circulating blood.

Bepirovirsen was discovered by, and jointly developed, with Ionis Pharmaceuticals.

The B-Clear phase 2b study is investigating the efficacy and safety of 12 or 24 weeks treatment with bepirovirsen in people with CHB on stable NA treatment or not on NA treatment at study start. The primary endpoints are the proportion of patients achieving HBsAg levels below the Lower Limit of Quantification (LLOQ), and HBV DNA levels below LLOQ sustained for 24 weeks without rescue medication after end of treatment with bepirovirsen.

The study consists of 2 parallel cohorts, one for patients receiving NA treatment and the other for patients who were not on NA. Patients from each arm were randomised to 1 of 4 treatment arms within each cohort, with treatment administered weekly with or without loading doses (LD) on days 4 and 11:

Bepirovirsen 300 mg with LD for 24 weeks;

Bepirovirsen 300 mg with LD for 12 weeks then 150 mg for 12 weeks;

Bepirovirsen 300 mg with LD for 12 weeks then placebo for 12 weeks;

Placebo with LD for 12 weeks then bepirovirsen 300 mg without LD for 12 weeks.

In both cohorts, virologic responses were observed at the end of treatment:

For those patients receiving NA treatment (n=227), 24 weeks treatment of 300 mg bepirovirsen resulted in HBsAg < LLOQ and HBV DNA < LLOQ in 28% of patients at end of treatment.

For patients not on NA (n=230), 24 weeks treatment of 300 mg bepirovirsen resulted in HBsAg < LLOQ and HBV DNA < LLOQ in 29% of patients at end of treatment.

The durability of these responses is being assessed.

“These encouraging data support further investigation of bepirovirsen, both as monotherapy and in combination, as a potentially transformative new treatment option for patients with chronic hepatitis B,” GSK Senior Vice President, Development, Chris Corsico, said.

The investigational therapy’s data points to a path towards a potential functional cure. 

GSK Reports Phase 2B Results on Bepirovirsen for Chronic Hepatitis B Treatment   


On Friday, CDC Director Rochelle P. Walensky signed off on the primary series for the the Moderna vaccine, mRNA-1273, (Spikevax), after the ACIP recommended the vaccine for children in these age groups. This endorsement paves the way for the Emergency Use Authorization (EUA) to take effect and the vaccine to become available for individuals 6 through 17 years of age.

“It is critical that we protect our children and teens from the complications of severe COVID-19 disease,” Walensky said in a statement released on Friday. “Today, we have expanded the options available to families by recommending a second safe and effective vaccine for children ages 6 through 17 years. Vaccinating this age group can provide greater confidence to families that their children and adolescents participating in childcare, school, and other activities will have less risk for serious COVID-19 illness.”

This becomes the second COVID-19 vaccine available for this pediatric population in the United States. The first one was the Pfizer vaccine authorized.

The decisions by CDC and the Food and Drug Administration (FDA) make it possible for providers and families to choose between the 2 mRNA vaccines in the primary series.

Earlier in June, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted to recommend amending the EUA for the Moderna vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age.

They voted twice splitting it to address younger children and then adolescents due to the different dosage in the vaccines. For the 6-11 year old group, they are using 50mcg for each dose, and for the 12-17 year old group, they are using 100mcg for each dose.

"We are thrilled that the FDA has granted Emergency Use Authorization of Moderna's COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children," Moderna CEO Stéphane Bancel, said in a statement at the time of the FDA’s vote. "Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings. Our pediatric COVID-19 vaccine is a two-dose regimen for all children 6 months and older, providing protection against COVID-19 two weeks after the second dose."

In the same statement, Moderna said their vaccine will be available for children and adolescents at select vaccination sites in the coming days. 

Rochelle P. Walensky, MD, MPH, signs off on the Centers for Disease Control and Prevention’s  (CDC) Advisory Committee on Immunization Practices’ (ACIP) recommendation for individuals 6 through 17 years of age.

CDC Director Endorses ACIP Recommendation for Moderna COVID-19 Vaccine for Children and Adolescents

The Centers for Disease Control and Prevention (CDC) released a statement this week urging gay, bisexual men, and men who have sex with men to get a meningococcal vaccine (MenACWY) if they either live in, or plan to travel to Florida.

This comes on the heels, of at least 24 cases and 6 deaths in these populations that have been reported.

“Getting vaccinated against meningococcal disease is the best way to prevent this serious illness, which can quickly become deadly,” said José R. Romero, MD, director, National Center for Immunization and Respiratory Diseases, said in a statement. “Because of the outbreak in Florida, and the number of Pride events being held across the state in coming weeks, it’s important that gay and bisexual men who live in Florida get vaccinated, and those traveling to Florida talk to their health care provider about getting a MenACWY vaccine.” 

The meningococcal conjugate (MenACWY) vaccines Menactra and Menveo are indicated for people 2 months of age up to 55 years depending on the vaccine. In addition, a newer meningococcal conjugate vaccine, MenQuadfi (MenACWY-TT), is a prophylaxis measure against invasive meningococcal disease caused by 

s in individuals beyond the traditional cutoff at age 55 years.

In addition, in a population that is at a higher risk of HIV, a recent study conducted by investigators found that people with HIV were at a 4.5- to 12.9-fold increased risk of meningococcal disease compared to an otherwise healthy population

CDC reminds the public that symptoms can appear suddenly and include high fever, headache, stiff neck, nausea/vomiting, or a dark purple rash. Symptoms can first appear as a flu-like illness, but typically worsen very quickly. People spread meningococcal bacteria to others by sharing respiratory and throat secretions (saliva or spit). Generally, it takes close or lengthy contact, such as kissing or being near someone coughing, to spread these bacteria.

Meningococcal disease can affect anyone and can be deadly and includes infections of the lining of the brain and spinal cord (meningitis) and bloodstream.

People can get meningococcal vaccines through their provider’s office, pharmacy, community health center, or local health department. According to CDC, insurance providers should pay for meningococcal vaccination for those whom it is recommended for during an outbreak. And in Florida, anyone can get a MenACWY vaccine at no cost at any county health department during the outbreak.

CDC continues to work with the Florida Department of Health to investigate this outbreak.


1. Bach A, Lee H, Lewis J. What’s new with non–COVID-19 vaccines. 

2. Lutz R. Meningococcal vaccine uptake low for new HIV patients. 

. June 7, 2022. Accessed June 24, 2022. Meningococcal Vaccine Uptake Low for New HIV Patients. 

https://www.contagionlive.com/view/meningococcal-vaccine-uptake-low-for-new-hiv-patients

The federal agency says this is one of the worst outbreaks of this disease among these groups in US history, and has public health officials concerned as people gather during ongoing Pride Month activities. 

CDC on the Meningococcal Disease Outbreak: Gay and Bisexual Men Should Get Vaccinated if Living or Traveling to Florida

The Food and Drug Administration (FDA) approved the pneumococcal 15-valent conjugate vaccine (Vaxneuvance) for the use in infants 6 weeks old through 17 years of age for pneumococcal disease. This Merck vaccine is indicated to provide protection against 

 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

This expanded indication comes nearly a year 

“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” Steven Shapiro, MD, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial, said in a statement. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”

The vaccine dosage is for 0.5 mL, and given as 4-dose series given at 2, 4, 6, and 12 through 15 months of age. The Vaxneuvance vaccine can also be administered as a single dose in children and adolescents 2 through 17 years of age who have received an incomplete series of another pneumococcal conjugate vaccine.

The FDA’s approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability and immunogenicity of the vaccine in infants, children and adolescents Clinical data from the pivotal study showed that immune responses elicited by Vaxneuvance following a four-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs).

The company offered more insights into their studies, including:

 The phase 3, multicenter, randomized, double-blind, active comparator-controlled study evaluated the safety, tolerability and immunogenicity of a 4-dose series of Vaxneuvance in healthy infants (n=1720) (V114-029/PNEU-PED [NCT03893448]). In the study, participants were randomized one-to-one to receive a four-dose series of Vaxneuvance or PCV13 at 2, 4, 6, and 12-15 months of age.

The assessed immune responses included serotype specific IgG response rates against capsular polysaccharides of 

 at 30 days post-dose 3 (PD3) and IgG geometric mean concentrations (GMCs) at 30 days PD3 and post-dose 4 (PD4). Additionally, antibody responses to other routine licensed pediatric vaccines were evaluated when administered concomitantly with Vaxneuvance or PCV13.

Vaxneuvance elicited immune responses for all 15 serotypes contained in the vaccine. Based on serotype-specific IgG GMCs, at 30 days PD4, Vaxneuvance was non-inferior to PCV13 for all 13 shared serotypes and the two serotypes unique to Vaxneuvance, 22F and 33F. Serotypes 22F and 33F were compared with serotype 4, which had the lowest IgG GMC of all shared serotypes in PCV13, excluding serotype 3. Results of the secondary analysis showed superior immune responses for the vaccine in comparison to PCV13 for serotypes 3, 22F and 33F.

 A phase 3, randomized, double-blind, active comparator-controlled, descriptive study evaluated the interchangeability of Vaxneuvance and PCV13 with respect to safety, tolerability and immunogenicity in healthy infants (n=900) (V114-027/PNEU-DIRECTION [NCT03620162]). The study demonstrated generally comparable immune responses for participants completing the vaccination series with Vaxneuvance compared to those who completed series with PCV13, for the 13 shared serotypes. The safety profile observed when the vaccine was used to complete a four-dose pneumococcal conjugate vaccine series initiated with PCV13 was similar to the safety profile following a complete 4-dose regimen of either Vaxneuvance or PCV13.

 A phase 3, randomized, double-blind, active comparator-controlled, descriptive study evaluated the safety, tolerability and immunogenicity of catch-up vaccination regimens of Vaxneuvance in healthy infants, children and adolescents 7 months to 17 years of age (n=606) (V114-024/PNEU-PLAN [NCT03885934]). The study demonstrated generally comparable immune responses after receipt of the last dose for the 13 serotypes targeted by Vaxneuvance and PCV13, and higher immune responses for the two serotypes unique to Vaxneuvance, 22F and 33F.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is meeting today to discuss and make recommendations on the use of the vaccine in pediatric populations.

The company’s 15-valent conjugate shot becomes the first one that is approved in nearly a decade.  

FDA Approves Expanded Indication for Merck’s Pneumococcal Vaccine for Infants and Children

With the big news this past week that the 2 mRNA (BioNTech and Moderna) vaccines 

 for use in children 6 months through 5 years of age, and the 

 this past Saturday, availability of the vaccines for this pediatric population will likely happen this week.

The last couple of years has been a reminder of the proven and worthy endeavor of investing in vaccines. Certainly, the COVID-19 vaccines have led the way, and with new technology such as the mRNA platform, combination vaccines and shots for latent viruses such as 

, has placed this form of prophylaxis medicine at the forefront.

Here are some of the specific vaccines in a few areas within infectious disease that are in various stages of development or have been approved.

. They have been at the forefront of mRNA COVID-19 vaccines. This was 

 to get the EUA in December 2020 for the adult population and they followed suit later with being the first vaccine to be eligible for children and teens. Just this past week, they were one of 2 mRNA vaccine developers who were granted the amended EUA for children 6 months to 5 years old.

 This was the second vaccine granted an FDA EUA in the United States for adults first, and just last week, for children. The company believes 

the mRNA technology can be applied to various diseases

 and conditions and they are also investigating combination vaccines that can be administered annually to combat COVID-19, influenza, and respiratory syncytial virus (RSV).

the FDA approved the company’s 15-valent conjugate vaccine

 in those 18 years and older. This includes prevention of the disease caused by serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. These infections can affect the young and older populations, and pneumococcal disease refers to any infection caused by bacteria called Streptococcus pneumoniae, or pneumococcus. Pneumococcal infections can range from ear and sinus infections to pneumonia and bloodstream infections according to CDC. 

In addition, July 1 is the target date for its supplemental BLA for this vaccine in infants and children, six weeks old through 17 years of age.

. Utilizing another technology platform, this vaccine was recently 

. It is currently being used internationally in several countries. In speaking to 

some insights into how this vaccine differs

. Being studied for seniors, which is 1 of 2 populations—babies, toddlers being the other—that are greatly affected by this virus. For its phase 3 study, GSK announced this month that their shot—a single dose of 

—administered in individuals aged 60 years and above was efficacious. This was a large study looking at approximately 25,000 participants from 17 countries.

 The smallpox vaccine is being utilized for monkeypox prevention. It is important to note it is being used only in close personal contacts with those who have contracted monkeypox. 

Although the smallpox vaccine is not administered anymore in the US as part of the vaccine schedule for children, it remains in American stockpiles for biohazard terrorism prevention. In fact, just last week, the company, Bavarian Nordic, announced that the US Biomedical Advanced Research and Development Authority (BARDA) ordered an additional 500,000 doses of liquid-frozen JYNNEOS, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox, for delivery in 2022. 

Studies, advances, and authorizations continue in this paramount area within infectious disease.

John Parkinson

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