Vaccine Breaking News

The U.S. Centers for Disease Control and Prevention (CDC) today announced four additional influenza-associated pediatric fatalities have occurred during the 2022-2023 flu season in the United States.

A total of 138 pediatric flu deaths have been reported so far this flu season.

The good news is the CDC FluView week #12 report confirmed seasonal flu rates were low nationally last week, with outpatient respiratory illness below baseline, and eight of 10 HHS regions are below their respective baselines as of March 31, 2023.

Previously, the World Health Organization published Influenza Update N° 401 on March 20, 2023, stating most indicators of influenza activity decreased to levels similar to or below levels typically observed this time of year in the Northern Hemisphere.

The CDC suggests anyone traveling to the Southern Hemisphere in April 2023 speak with a healthcare provider about potentially getting an additional flu shot for protection.

Flu shots remain available for most people over six months at most clinics and pharmacies in the U.S.

As of March 4, 2023, about 173.37 million influenza vaccines had been distributed during the 2022-2023 flu season. 

The Janssen Pharmaceutical Companies of Johnson & Johnson recently disclosed that after assessing the respiratory syncytial virus (RSV) vaccine landscape, the Company would discontinue its RSV adult vaccine program.

“By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients’ lives,” said Bill Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation and Medical Officer and Interim Head, Janssen R&D., in a press release on March 29, 2023.

The decision to discontinue the RSV adult vaccine program is part of a broader effort to make strategic choices for its investments to focus on medicines with the greatest potential benefit to patients. 

As of March 31, 2023, the U.S. FDA has not approved any RSV vaccine candidate.

However, the FDA previously approved monoclonal antibody therapies for infants.

Lucira Health, Inc. announced today both the nationwide launch of its breakthrough Lucira COVID-19 & Flu Home Test in the United States and the combination test's inclusion in the Australian Register of Therapeutic Goods for use by healthcare professionals in a point-of-care setting.

The COVID-19 & Flu Home Test is the first and only combination COVID-19 & Flu test to be granted emergency use authorization by the U.S. Food and Drug Administration for over-the-counter (OTC) use at home and other non-laboratory sites.

The all-in-one combination test delivers results from one shallow nasal swab in 30 minutes or less.

This OTC test is a molecular nucleic acid amplification test, not an antigen test.

The Lucira COVID-19 & Flu Home Test is a molecular test demonstrating similar performance for COVID-19 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials.

"Both of these accomplishments represent important milestones for Lucira and underscore the viability of the Lucira technology platform in both at-home and point-of-care settings around the globe," said Erik Engelson, President and CEO of Lucira Health, in a press release on March 28, 2023.

"U.S. consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home."

"With one-touch access to telehealth via our Lucira Connect web platform, they can now get onto the path to treatment and recovery within hours of receiving a test result from the comfort of home."

This test can be purchased in the U.S. for $34.99 at www.lucirahealth.com/flu.

While the annual flu season in the United States has subsided, India's government reports an unusual influenza surge.

PTI reported today Minister of State for Health Bharati Pravin Pawar informed the Rajya Sabha that 1,317 cases of H3N2 have been confirmed from January to March 21, 2023.

According to the Indian Council of Medical Research, of 510 H3N2 cases reported in the last two months, 19 patients required ICU admission, Pawar wrote to PTI on March 28, 2023.

The H3N2 virus spreads from an infected person through droplets in the air or direct contact with virus-laden surfaces, says the U.S. CDC.

The severity of human illness caused by H3N2 is similar to seasonal flu, which can become severe if complications like pneumonia develop.

Another influenza version is called 'swine flu.'

H3N2v is a non-human influenza virus that normally circulates in pigs. Viruses that normally circulate in pigs are "swine influenza viruses." When these viruses infect humans, they are termed "variant" viruses, says the CDC. Furthermore, the seasonal flu shot does not protect against H3N2v. 

The CDC's FluView Interactive Novel Flu A digital tool displays the most current case counts for variant virus infections reported in the U.S.

Previously, India's government confirmed that young children and old persons with co-morbidities are the most vulnerable groups in seasonal influenza.

Seasonal influenza is an acute respiratory infection caused by influenza viruses that circulate in all parts of the world, and the cases are seen to increase during certain months globally.

The cases arising from seasonal influenza in India are expected to decline by the end of March 2023.

The World Health Organization published Influenza Update N° 401 on March 20, 2023, stating most indicators of influenza activity in the Northern Hemisphere decreased to levels similar to or below levels typically observed this time of year.

In the U.S., annual flu shots remain available at many clinics and community pharmacies.

The New York State Department of Health (NYSDOH) recently confirmed the presence of poliovirus in Rockland County wastewater for the first time since October 2022.

This single positive result was collected in February 2023.

However, sequencing analysis by the U.S. Centers for Disease Control and Prevention (CDC) confirmed as of March 22, 2023, the presence of poliovirus in 101 positive wastewater samples, most linked to the individual case of paralytic polio among a Rockland County resident in 2022.

Transmission of this disease only continues if the overall polio vaccination rates remain low, says the CDC.

"It is our obligation to protect all our residents from debilitating and potentially fatal diseases," said Rockland County Executive Ed Day in a press release. 

"I urge our residents to act now and protect yourselves, your family, and your community."

"Polio is preventable through the complete vaccination series."

As of mid-March, 19,282 doses of the polio vaccine have been administered to Rockland County residents.

In 2022, there were over 330,000 residents in Rockland County.

"While certainly, the number of doses is strong, the polio vaccine is a series of 4-doses, so it takes time to reach full protection," added Day. 

"As I've said before, this is why it is crucial for schools and the New York State Education Department to maintain and enforce these required vaccinations."

"But families with unvaccinated children who are not yet of school age completely lack protection from this dreaded disease and must get on the schedule now."

Rockland County Department of Health (RCDOH) is actively working on strategies to increase vaccination rates, including working with the CDC and NYSDOH to perform daycare and school assessments and audits.

To enhance local detections, New York recently received $21.6 million in funding to expand its wastewater surveillance and infectious disease monitoring capabilities.

In 2023, this funding will increase the number of participating sewer sheds from 125 to over 215, reaching about 81% of the population of New York public sewer systems.

Moreover, with holiday travelers peaking this spring break, enhancing protection from polio is a priority, says the CDC.

For example, Israel's Ministry of Health also recently confirmed four children tested positive for poliovirus in Northern Israel.

With increased travel expected between New Yorkers and Israel over Passover 2023, the RCDOH reminds families there is a real risk of paralysis if they are unvaccinated.

Furthermore, adults who completed the polio vaccine series as children may receive a one-time polio booster dose before traveling abroad to any of the thirty countries reporting poliovirus detections.

And any New York resident who needs vaccination can obtain one by calling the RCDOH at 845-364-2520 or 845-364-2524.

Throughout the U.S., polio vaccines are offered by health clinics and community pharmacies as of March 28, 2023.

BioNTech SE today reported financial results as of December 31, 2022, and provided an update on its corporate progress.

In December 2022, BioNTech and Pfizer announced that approximately 2 billion doses of COMIRNATY®  were invoiced globally in 2022 between the two companies.

This includes approximately 550 million doses of the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine as of mid-December 2022.

And as part of BioNTech's and Pfizer's 2-billion-doses-pledge to support equitable access to medicines, the companies have delivered approximately 1.7 billion doses of COMIRNATY to low- and middle-income countries in line with demand.

The deliveries include the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine and the original COVID-19 vaccine. 

"Our COVID-19 vaccine revenues, driven by the delivery of our Omicron-adapted bivalent vaccines, have ensured another strong financial performance in 2022," said Jens Holstein, CFO of BioNTech, in a press release on March 27, 2023.

"We believe that the Company's financial success in 2022 will provide a springboard to accelerate and build upon our diversified clinical pipeline and fuel our research and development in the coming years. 

The complete press release is posted at this link.

The World Health Organization (WHO) recently published Influenza Update N° 441, confirming influenza activity continued to decrease following the peak in late 2022.

In the countries of North America, most indicators of influenza activity were at levels typically observed towards the end of the flu season.

Influenza A viruses predominated overall, with influenza A(H3N2) accounting for most subtyped influenza A viruses in the United States, whereas influenza A and B viruses circulated similarly in Canada.

And in Europe, out of 39 countries, 17 reported high or moderate intensity, and over half continued to report widespread activity.

Overall, influenza B viruses were predominated in both sentinel and non-sentinel surveillance as all subregions experienced a wave of influenza B activity after an initial influenza A surge.

While the Northern Hemishpere flu season is ending, the WHO's data on March 20, 2023, indicates the Southern Hemishpere is just starting.

For international travelers, the means another flu shot may be needed when visiting countries such as Brazil, Peru, or Argentina later this year.

Community pharmacies in the U.S. generally offer influenza vaccines throughout the year.