Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations

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

Mar 9, 2023 • 2:39 pm CST
U.S. CDC March 10, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today published enhanced recommendations for the screening and testing for Hepatitis B Virus (HBV) infection.

As of March 10, 2023, the CDC confirms universal screening of adults for HBV infection is cost-effective compared with risk-based screening and averts liver disease, cirrhosis, and death.

Furthermore, chronic HBV infection is detectable using reliable and inexpensive screening tests.

In addition, although not quantifiable, management of chronic infection through prevention efforts can prevent further transmission to others.

These recommendations consider a more straightforward and less stigmatizing implementation strategy than previous risk-based HBV screening recommendations, says the CDC's Morbidity and Mortality Weekly Report.

The CDC's new recommendations also provide guidance complementary to the 2022 recommendations to vaccinate all adults aged 19–59 years against HBV infection by providing a means to establish immunity, any history of infection, or the need for vaccination to protect from future infection. 

Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an HVB vaccine update.

The CDC says effective vaccines to prevent hepatitis B are available in the U.S.

Mar 9, 2023 • 12:14 pm CST
WHO March 6, 2023

The World Health Organization (WHO) recently published Influenza Update N° 440, influenza activity continued to decrease following a peak in late 2022.

As of March 6, 2023, influenza A viruses predominated, and the proportion of influenza B virus detections increased during the current reporting period.

In the countries of North America, most indicators of influenza activity decreased to levels similar to or below levels typically observed towards the end of the season.

In Europe, overall influenza detections remained stable, and influenza positivity from sentinel sites increased in the most recent week, remaining above the epidemic threshold at the regional level.

Out of 39 countries, 18 reported high or moderate intensity, and over half continued to report widespread influenza case activity.

Other indicators of influenza activity remained stable or decreased in most countries, while a few countries reported increases.

Various types of flu shots remain available in the U.S. and Europe as of March 9, 2022.

As of February 25, 2023, the Centers for Disease Control and Prevention confirmed about 173.26 million flu shots had been distributed in the U.S. during this season. 

Additional 2022-2023 flu season news is posted at

Mar 9, 2023 • 11:51 am CST
ECDC Marburg cases March 2023

The World Health Organization (WHO) today announced it would conduct a digital webinar tomorrow discussing Marburg virus vaccine and therapeutic candidates and how research can be integrated during future outbreaks.

The recent emergence of the Marburg virus (MARV) in Equatorial Guinea (Feb. 2023) and Ghana triggered the assembly of the "MARVAC" consortium in 2022 to facilitate a rapid response to this infectious disease threat. 

As of March 9, 2023, several MARV vaccine candidates are conducting early-stage clinical studies. 

On March 10, 2023, at 14:00 CET, from this Zoom link, the WHO R&D Blueprint is organizing a consultation with the MARVAC partners and focal points from at-risk countries to discuss this preliminary agenda:

  • Outbreak sit rep, including diagnostics and epidemiology,
  • Review of core trial protocols for vaccines and therapeutics,
  • Panel discussion from at-risk country focal points

Since 1967, Angola, DR Congo, Equatorial Guinea,  Cameroon, Germany,  Ghana,  Guinea,  Kenya,  Serbia, South Africa, and Uganda have confirmed Marburg cases.

The U.S. Centers for Disease Control and Prevention published the History of Marburg outbreaks.

Mar 9, 2023 • 8:06 am CST
by Luis Oliveira

ModeX Therapeutics, Inc. recently announced it entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX-2201, a preclinical nanoparticle vaccine candidate targeting Epstein-Barr virus (EBV).

Under the terms of the agreement, ModeX and Merck will jointly advance MDX-2201 to a U.S. FDA Investigational New Drug application filing, after which Merck will be responsible for clinical and regulatory activities and product commercialization.

MDX-2201 is based on ModeX’s ferritin nanoparticle vaccine platform, which can express as many as 24 copies of a recombinant antigen on its surface to enhance the presentation of key virus components and stimulate durable protective immunity.

MDX-2201 presents antigens from four viral proteins involved in viral entry into host cells.

These include a recombinant antigen designed from the proteins gH, gL, and gp42 and an antigen derived from gp350.

By using ModeX’s multi-targeted approach, this combination inhibits infection in two cell types, B cells and epithelial cells, contrasting with efforts previously focused on gp350 alone.

“At Merck, we have a proud legacy of developing vaccines, including several that have the potential to help protect against certain types of cancer,” said Tarit Mukhopadhyay, Ph.D., Vice President, Infectious Diseases and Vaccine Discovery, Merck Research Laboratories, in a press release on March 8, 2023.

EBV is a member of the herpes virus family and is one of the most common human viruses.

EBV can cause infectious mononucleosis and is associated with other illnesses, including specific types of cancer and multiple sclerosis. Unfortunately, there are currently no FDA-approved vaccines or treatments for EBV infection.

However, Moderna Inc. has been conducting a phase 1 clinical study for its mRNA-1189 vaccine candidate.

The viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system.