Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations

Mar 20, 2023 • 8:00 am CDT
by Engin Akyurt

Vaccitech plc today announced topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 heterologous prime-boost immunotherapy in women with low-grade cervical human papillomavirus (HPV) lesions.

It is estimated that approximately 291 million women worldwide are carriers of HPV DNA.

Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2, and E6 antigens.

VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.

"These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024," said Bill Enright, CEO of Vaccitech, in a press release on March 20, 2023.

"Currently, people with persistent HPV infections have no treatment options until they develop high-grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking."

"VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions."

VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.

Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.

Over 95% of cervical cancers are caused by HPV infection.

The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the U.S., with over 4,280 women dying from the disease.

In the U.S., various HPV vaccines are authorized for women and men and available at most clinics and clinical pharmacies in March 2023.

Mar 17, 2023 • 1:55 pm CDT
by Ben Menting

The U.S. Centers for Disease Control and Prevention (CDC) Technical Report issued on March 17, 2023, stated that despite the geographic spread of highly pathogenic avian influenza (HPAI) A(H5N1) viruses, only a small number of 'bird flu' cases in people have been identified.

The CDC stated all reported human cases since 2022 have been associated with poultry exposures.

And no bird flu cases of human-to-human transmission have been identified, says the CDC.

However, because of the potential for influenza viruses to evolve rapidly, continued sporadic human infections are anticipated.

To date, more than 6,300 people in 52 jurisdictions have been monitored since 2022, and only one human case in Colorado has been identified.

However, there has been an upsurge in various mammals dying from bird flu in Canada and the U.S. during 2023.

The CDC presented some good news regarding bird flu vaccines.

An H5 candidate vaccine virus (CVV) produced by CDC is nearly identical or, in many samples, identical to the hemagglutinin (HA) protein of recently detected clade HPAI A(H5N1) viruses in birds and mammals and could be used to produce a vaccine for people. 

This H5 CVV is available and has been shared with vaccine manufacturers.

One manufacturer, CSL Seqirus Inc., has already produced a U.S. FDA-approved vaccine, Audenz™.

Audenz is a monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine designed to protect people from bird flu.

Mar 17, 2023 • 11:42 am CDT
U.S. CDC U.S. Influenza Surveillance Report Week #10

The U.S. Centers for Disease Control and Prevention (CDC) today reported two insightful data points. First, as of March 17, 2023, the CDC's national outpatient respiratory illness data is now below baseline, as are six of 10 HHS regions.

This data indicates the 2022-2023 flu season in the U.S. is coming to an early close.

However, as of week #10 data, seven additional influenza-associated pediatric deaths occurred.

The deaths occurred between week #47 of 2022 and week #9 of 2023.

All seven deaths were associated with influenza A viruses. Four of the influenza A viruses had subtyping performed; one was an A(H1N1) virus, and three were A(H3) viruses.


This CDC update means there have been 132 influenza-associated pediatric deaths this flu season, the most significant amount since 2019.

The CDC continues to remind everyone that flu shots remain available at most health clinics and pharmacies in the U.S.

Mar 16, 2023 • 12:41 pm CDT
from Pixabay

GSK plc recently announced positive results from a phase 3 clinical trial evaluating its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years.

GSK's MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).

All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response.

In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.

Tony Wood, Chief Scientific Officer at GSK, commented in a press release on march 14, 2023, "These statistically significant phase III data are a very encouraging step toward reducing the incidence of meningococcal disease."

"In the U.S., routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease's incidence peak, could drive significant public health impact."

Invasive meningococcal disease (IMD), a significant cause of meningitis and septicemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents.

Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases worldwide.

Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. 

As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine.

Currently, in the U.S., two separate vaccines needing four injections are required to protect against all five serogroups.

This immunization regimen and low awareness of the disease can lead to sub-optimal immunization coverage rates, particularly for MenB, with an estimated coverage of only about 31% of adolescents in the U.S.

GSK works closely with regulators to review the complete phase III data set, including the supplemental Biologics License Application for Bexsero.

This clinical trial was the confirmatory trial for Bexsero and the phase III trial for MenABCWY.

Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings.

Mar 15, 2023 • 10:17 am CDT
Canada's HI3 Hub March 2023

The Government of Canada today confirmed its' main priority continues to be protecting the health and safety of Canadians. Throughout the recent pandemic, decisive actions taken empowered Canada to scale up domestic biomanufacturing capacity, which had been in decline for over 40 years.

On March 14, 2023, Adam van Koeverden, Parliamentary Secretary to the Minister of Health and to the Minister of Sport, highlighted in a press release an investment of $2 million to create the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases (HI3).

This support is part of a $10 million investment announced on March 2, 2023, for creating five research hubs as part of Stage 1 of the integrated Canada Biomedical Research Fund and Biosciences Research Infrastructure Fund competition.

The University of Toronto (UofT) leads the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases.

The HI3 hub is led by co-directors Jen Gommerman and Scott Gray-Owen, professors of immunology and molecular genetics, respectively, in the Temerty Faculty of Medicine at U of T. 

It will focus on advancing the concept of "personalized and precise medicine" to influence the development of vaccines, therapeutics, and other public health interventions.

Mar 15, 2023 • 7:48 am CDT
by Rolando Otero

The U.S. Food and Drug Administration (FDA) presented some good news last week regarding influenza vaccines. The FDA confirmed this season's influenza vaccination provided substantial protection against inpatient, emergency department, and outpatient illnesses among all ages.

On March 7, 2023, Lisa Grohskopf, MD, MPH, with the U.S. Centers for Disease Control and Prevention (CDC), presented to the FDA's Vaccines and Related Biological Products Advisory Committee updated vaccine effectiveness (VE) information through January 2023.

Dr. Grohskopf's presentation highlighted influenza vaccination significantly reduced disease by the following:

  • 39% (95%CI: 31, 45) against adult hospitalizations,
  • 44% (95%CI: 41, 47) against adult ED or UC visits, and
  • VE was observed across age groups and immunocompromised.

Furthermore, this flu season's estimates are higher than VE estimates against hospitalization (25%) and ED or UC visits (25%) from the 2021–22 season.

As of March 15, 2023, the CDC says various flu shots remain available at most clinics and pharmacies in the U.S., and late-season vaccinations are advised for certain at-risk people.

Over 173 million influenza vaccines have already been distributed this flu season.

Mar 14, 2023 • 7:59 pm CDT
by Christina from Pixabay

The U.S. Food and Drug Administration (FDA) today announced it amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children six months through 4 years of age at least two months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.

Since December 2022, children six months through 4 years of age who receive the first two doses with the monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

“Today’s authorization provides parents and caregivers of children six months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on March 14, 2023.

“Currently available data show that vaccination remains the best defense against severe disease, hospitalization, and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.” 

The fact sheets for recipients, caregivers, and healthcare providers include information about the vaccine’s potential side effects and the risks of myocarditis and pericarditis.

The amendment to the EUA was issued to Pfizer Inc.

Mar 14, 2023 • 4:15 am CDT
by Kevin Phillips

A recent Lancet Lancet Infectious Diseases analysis concluded that a single dose of Modified Vaccinia Ankara (MVA-BN, Jynneos®) vaccine was very protective against mpox.

Published on March 13, 2023, Dimie Ogoina, with Niger Delta University and colleagues, wrote the 78% vaccine effectiveness reported suggests that a single dose of Jynneos is considered protective against symptomatic mpox only after 13 days post-vaccination.

Furthermore, this analysis and other studies suggest that using a single dose of Bavarian Nordic's Jynneos as pre-exposure prophylaxis is preferable to post-exposure prophylaxis to guarantee protection against symptomatic mpox.

And because people living with HIV have been shown to have a higher risk of breakthrough COVID-19 infections post-vaccination, identifying four of eight breakthrough mpox infections among people living with HIV is noteworthy.

However, the Jynneos vaccine has previously been shown to be immunogenic among adults with a history of AIDS.

Since there are no approved HIV vaccines, co-administration data is unavailable.

Additional Mpox outbreak news is posted at MpoxToday.

Mar 13, 2023 • 5:48 pm CDT
by Virat Maurya

Communities in India have voiced strong interest in accessing HIV self-testing, says the World Health Organization (WHO). 

The WHO today announced it recommends HIV self-testing (HIVST) as an important approach to address gaps in HIV diagnoses, including among key populations in India.

HIVST can also generate demand for prevention services and facilitate pre-exposure prophylaxis delivery. 

The first of the United Nations’ 95-95-95 targets to end the HIV epidemic is for 95% of people living with HIV to know their HIV status by 2025. HIV testing is therefore essential to achieving “the first 95”.

A report launched in New Delhi in 2022 showed HIVST is acceptable to key populations and their partners in India. 

In the U.S., clinicians are recommended to screen for HIV infection in all pregnant women, including those who present in labor or at delivery and whose HIV status is unknown.

And screening is endorsed for certain adolescents and adults who are at increased risk of HIV infection.

Globally, 98 countries now have policies supportive of HIVST, and 52 are routinely implemented, yet many countries have not yet introduced HIVST as a routine approach. 

Until HIV-preventive vaccine candidates are approved, HIVST is a key component to reducing infections.

Mar 13, 2023 • 2:47 pm CDT

Eisai Co., Ltd. today announced that the U.S. Veterans' Health Administration (VHA) is providing coverage of LEQEMBI™ to veterans living with early stages of Alzheimer's disease (AD).

As of March 13, 2023, VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA's standards and the U.S. Food and Drug Administration's (FDA) current label.

The FDA-approved LEQEMBI under the accelerated approval pathway in January 2023, and was launched in the U.S. on January 18, 2023.

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ),

Treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology, the population in which treatment was initiated in clinical trials.

After the first infusion, 38% of LEQEMBI-treated patients had transiently decreased lymphocyte counts to <0.9 x109/L compared to 2% on placebo, and 22% of LEQEMBI-treated patients had transiently increased neutrophil counts to >7.9 x109/L compared to 1% on placebo.

Furthermore, there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

LEQEMBI is not a vaccine but is therapeutically administered via infusion.

In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered. 

The FDA has not approved an Alzheimer's disease vaccine as of March 2023.

Mar 12, 2023 • 2:46 pm CDT
by Ahnaf Piash

Parents living in St. Thomas, Elgin, and Oxford counties in Ottawa were recently advised to be alert to respiratory symptoms, which are particularly dangerous in young children.

Symptoms of the vaccine-preventable disease pertussis start with a runny nose or nasal congestion, sneezing, mild cough, and mild fever.

Southwestern Public Health, which is located between Detroit and Toronto, announced on March 8, 2023, parents and guardians should keep themselves and their children up to date with the pertussis vaccine after a recent dramatic rise in cases in the region.

"Our region has seen 82 confirmed cases of pertussis between January 2022 and February 28, 2023. This represents about 40% of the provincial total from that time period."

"Combine this with the number of children who are unvaccinated or under-vaccinated, and I am concerned in particular for the youngest members of our community," says Dr. Ninh Tran, Medical Officer of Health for Southwestern Public Health, in a related press release.

Pertussis, commonly known as whooping cough, is a vaccine-preventable disease.

This vaccine is routinely administered to children along with protection from polio, tetanus, and diphtheria (DTaP).

In the U.S., DTaP vaccines such as Boostrix are offered at clinics and pharmacies.

Pertussis is very contagious and spreads via droplets from the noses and mouths of those who are infected.

The cough, which can last anywhere from 2 – 8 weeks, gets progressively worse and may lead to vomiting or trouble breathing and coughing up mucous. It can often be recognized by the loud "whooping" sound that occurs when the child is inhaling after a coughing spell.

Untreated pertussis in infants can lead to hospitalization, brain damage, and death.

Furthermore, new research indicates an expecting mother can take action to protect her future child.

According to an Original Investigation published by JAMA Pediatrics in February 2023, maternal Tdap vaccination reduces pertussis burden in infants (2 months).

"I have two asks of our local parents."

"The first is that you make yourself familiar with the symptoms of pertussis and seek medical care if your child has these symptoms."

"It can be treated with antibiotics, and after five days on the treatment, the person can no longer spread the disease to others."

"Second, please contact your family health care provider or Southwestern Public Health to get your child's routine vaccinations up to date."

"The vaccine is free, and we have openings in our clinics throughout the month of March," adds Tran.

Ottawa residents requiring a public health vaccination clinic appointment can book online at

Mar 12, 2023 • 12:08 pm CDT
South American sea lions - by Lars Schlageter

The U.K. National History Museum recently reported sea lions in Peru are among the latest victims of a version of the highly pathogenic avian influenza (HPAI) known as bird flu.

The HAPI virus has killed about 3,500 South American sea lions in Peru as of March 9, 2023.

The Peruvian government has reported that since November 2022, around 3% of the country's sea lions have died due to HPAI infections.

Peru, like many South American countries, believes HAPI was brought south by pelicans before jumping into the marine mammals. 

In the Northern Hemisphere, Canada and the United States have reported multiple mammalian fatalities related to bird flu infections.

The United States Department of Agriculture and the World Animal Health Information System reported during March 2023, over 131 HAPI H5N1 detections of wild striped skunks, black bears, raccoons, and red foxes.

  • The California Department of Fish and Wildlife received confirmation on February 15, 2023, that an adult bobcat died from the Eurasian strain of HPAI H5N1.
  • The Colorado Parks and Wildlife confirmed on February 9, 2023, several cases of HPAI in free-ranging wildlife (black bear, skunk, mountain lion).
  • The Montana Department of Fish, Wildlife, and Parks confirmed on January 17, 2023, three juvenile grizzly bears tested positive for HAPI.

While there are no vaccines that protect birds or mammals from H5N1 infections, there are bird flu vaccines for humans.

In the U.S., the Food and Drug Administration authorized CSL Seqirus' Audenz™ vaccine on January 31, 2020, and RAPIVAB® in 2022.

And the U.S. government has financially supported the development of newer bird flu vaccines for people.

Furthermore, the government reminds everyone that annual flu shots are effective against certain types of influenza, but they are not effective against bord flu viruses.

Mar 11, 2023 • 12:04 pm CST

The Centers for Disease Control and Prevention (CDC) recently released a Morbidity and Mortality Weekly Report (MMWR) titled: Interim Clinical Treatment Considerations for Severe Manifestations of Mpox—United States, February 2023.

Published on March 3, 2023, this MMWR provides updated clinical treatment considerations about using therapeutic countermeasures to treat severe mpox cases.

Until data gaps are filled through randomized controlled studies and other carefully controlled research studies, this MMWR represents the best available information about human mpox treatment.

Previously, the CDC updated the U.S. National Mpox Vaccination Strategy on February 6, 2023.

The CDC continues to recommend people who have been exposed to the Mpox virus and people who may be more likely to contract mpox should be vaccinated.

The JYNNEOS® vaccine is available at certain clinics and pharmacies in the U.S.

Mpox is a disease caused by infection with the Monkeypox virus, an Orthopoxvirus in the same genus as the Variola virus, which causes smallpox.

In 2022, a global outbreak involving mpox clade IIb was detected sourced from the Canary Islands in early May. Since then, 1,201,210 JYNNEOS doses have been administered in the 57 U.S. Jurisdictions reported data.

Mar 10, 2023 • 12:39 pm CST
U.S. CDC PIC fatalities Mar. 10, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced about 8.9% of the deaths that occurred last week were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 2,172 PIC deaths reported by the National Center for Health Statistics Mortality Surveillance on March 9, 2023, 1,274 listed pneumonia as an underlying or contributing cause of death on the death certificate, 876 had COVID-19, and 22 listed influenza.

While everyone is aware of COVID-19 and flu shots, most people don't know pneumonia is also a vaccine-preventable disease.

The CDC also confirmed the proportion due to influenza increased from October through mid-December 2022, decreased for seven weeks, and has been stable at low levels for the past five weeks. 

Unfortunately, the CDC confirmed on March 10, 2023, a total of 125 influenza-associated pediatric deaths occurred during the 2022-2023 flu season. Previous data indicate about one-third of these children were vaccinated.

While the flu season is fading in most areas of North America, the CDC reminds international travelers a second flu shot this year may protect them when visiting at-risk countries in the Southern Hemisphere.

The World Health Organization published Influenza Update N° 400 on March 6, 2023, stating in the temperate zones of the Southern Hemisphere, influenza activity remained at interseasonal levels.

In the U.S., there were about 173 million flu shots distributed during 2022-2023.

And many health clinics and community pharmacies offer vaccination services in March 2023.

Mar 10, 2023 • 3:29 am CST
by Gerd Altmann

Reuters recently confirmed GSK plc expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. in 2023 without supply constraints.

"We are ready to launch without capacity or supply constraints... to supply the market (from its plant in Wavre, Belgium) that we see," Phil Dormitzer, Global Head of Vaccines R&D at GSK, commented in an interview on March 8, 2023.

GSK plc previously announced that the U.S. Food and Drug Administration (FDA) vaccine voted that the available data support the safety and effectiveness of GSK's AREXVY™ vaccine candidate for preventing lower respiratory tract disease caused by RSV in adults aged 60 years and older.

The FDA Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.

As of March 10, 2023, the FDA has yet to authorize AREXVY for use in the U.S.

Phil Dormitzer commented in a press release on March 1, 2023, "Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems."

AREXVY is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with initial decisions expected later in 2023. 

RSV is one of the major remaining infectious diseases for which no vaccine or specific treatment is available for adults. Older adults are at high risk for severe disease due in part to age-related decline in immunity,

Additionally, RSV is a very serious disease in young children.

Unlike seniors, children already have FDA-approved RSV protection from a monoclonal antibody (Synagis®), with another version under final review.

The European Medicines Agency recommended marketing authorization for Beyfortus® (nirsevimab) in 2022 to prevent RSV lower respiratory tract disease in infants during their first RSV season when there is a risk of RSV infection in the local community.

Additional RSV vaccine candidates and antibody therapy news are posted at