Vaccine Breaking News

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.

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.

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 www.swpublichealth.ca/booking.

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.

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 PrecisionVaccinations.com/RSV.

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 PrecisionVaccinations.com/Flu.