Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

May 24, 2022 • 9:44 am CDT
by Keith Johnston

The U.S. Centers for Disease Control and Prevention (CDC) issued today Health Alert Network Health Advisory CDCHAN-00467 to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or "COVID-19 Rebound." 

COVID-19 Rebound cases have been reported to occur between two and 8 days after initial recovery. They are characterized by a recurrence of COVID-19 symptoms or a new positive viral test after testing negative. 

A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the beta coronavirus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.

The CDC stated on May 24, 2022, 'limited information currently available from case reports suggests that persons treated with the oral antiviral Paxlovid who experience COVID-19 rebound have had a mild illness, as there are no reports of severe disease.'

Furthermore, 'there is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 Rebound is suspected.'

As of May 23, 2022, the U.S. government confirmed it had distributed 3,797,458 Paxlovid oral treatments since late 2021.

Paxlovid is approved by the U.S. FDA and in Europe, and is the first orally administered coronavirus-specific investigational protease inhibitor for certain adults and children diagnosed with COVID-19.

Paxlovid inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication.

Note: This CDC news was manually curated for mobile readers.

May 24, 2022 • 4:24 am CDT
by Gerd Altmann

Monkeypox is a zoonotic viral disease that occurs primarily in tropical areas of Central and West Africa, says the World Health Organization. And it is a vaccine-preventable disease.

Since 2019, the U.S. FDA has approved the Jynneos® (MVA-BN) vaccine to prevent both monkeypox and smallpox.

And the U.K. began offering its version IMVANEX® to specific individuals in England during mid-May 2022.

According to media reporting on May 23, 2022, the U.S. government is preparing to make the Jynneos vaccine available to certain people who are 'close contacts' of monkeypox patients.

The states of Florida, Massachusetts, New York, and Utah have confirmed monkeypox virus-infected patients in May 2022.

Unfortunately, Jynneos is in limited supply in the USA.

Globally, about (19) countries, including the USA, United Kingdom (Scotland), Spain, Switzerland, Sweden, Portugal, Morocco, Netherlands, Italy, Israel, Greece, Germany, France, Denmark, Canada, Belgium, Austria, Argentina, and Australia, have reported monkeypox cases during May 2022.

Worldwide, the total number of potential cases has reached about (260). 

Breaking news regarding the monkeypox outbreak is posted at Vax-Before-Travel.

Note: This information was manually curated for mobile readership.

May 24, 2022 • 4:04 am CDT
ASPR

The U.S. federal government replenishes COVID-19 therapeutic inventories each Monday. The current information from the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) indicates there is plenty of oral antivirals and monoclonal antibody (mAbs) supply available in the USA.

As of May 17, 2022, ASPR's COVID-19 Therapeutics Summary revealed:

  • Paxlovid: Ordered = 2,056,968, Administrered = 668,954

  • Lagevrio: Ordered = 1,799,949, Administrered = 230,257

  • Bebtelovimab: Ordered = 347,291, Administrered = 76,103

  • Evusheld: Ordered = 681,793, Administrered = 253,454

The U.S. FDA authorized COVID-19 oral antivirals Paxlovid and Lagevrio threshold amounts are determined on a pro-rata population basis.

And the mAbs treatment Bebtelovimab threshold amounts are determined using a disease-based methodology.

While the mAbs Evusheld threshold amounts are determined on a pro-rata population basis, and replenishment occurs monthly.

Furthermore, threshold quantities are determined by ASPR using the same methodology as previous allocations. 

Each state and territorial health department can make product requests at any time if a jurisdiction's current supply is not sufficient to meet demand.

Note: This ASPR information was curated for mobile readership.

May 24, 2022 • 3:14 am CDT
by Pete Linforth

AstraZeneca announced yesterday that its COVID-19 vaccine, Vaxzevria, was granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

The company stated on May 23, 2022, 'Healthcare professionals can now use Vaxzevria as a third dose booster in patients previously given a primary vaccine schedule of either Vaxzevria or an approved mRNA COVID-19 vaccine and now have greater flexibility in their choice of a vaccine.'

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said in the related press release, "Ensuring a longer duration of immune protection is essential to the long-term management of COVID-19 globally, and boosters can address the waning of protection over time that has been seen with all primary vaccine schedules to date."

Vaxzevria is already authorized as a homologous booster (patients previously given a primary vaccine schedule of Vaxevria) in the UK and several countries in Asia and Latin America.

It has also been authorized as a heterologous booster (patients previously given a primary vaccine schedule of either a viral vector vaccine other than Vaxzevria or an inactivated vaccine or an mRNA COVID-19 vaccine) in several non-EU countries.

Since the initial authorization, Vaxzevria is estimated to have helped prevent 50 million COVID-19 cases and five million hospitalizations and saved more than one million lives worldwide, based on model outcomes assessing COVID-19 worldwide.

Note: This announcement was curated for mobile readers.

May 22, 2022 • 5:05 am CDT
USDA

Whenever avian influenza viruses are circulating in poultry, there is a risk for human cases due to exposure to infected poultry, says the World Health Organization (WHO).

The WHO recently reported from 2003, a total of 864 cases and 456 deaths of influenza A(H5N1) human infection were recently confirmed by 18 countries.

And in the USA, a person has tested positive for avian influenza A(H5) virus as reported by Colorado and confirmed by U.S. CDC in late April 2022. 

The CDC has tracked the health of more than 2,500 people with exposures to H5N1 virus-infected birds this year, and this is the only case that has been found to date.

This is good news since the presence of highly pathogenic avian influenza (HPAI) has been confirmed in over 35 states as of May 18, 2022.

The most recent confirmed the presence of HPAI in a non-commercial backyard flock (poultry) was in Monmouth County, New Jersey.

According to the CDC, the public health risk associated with these avian influenza detections remains low. 

Furthermore, vaccines to prevent influenza A(H5) virus infection in humans have been developed for pandemic preparedness purposes. 

Seqirus Inc. Audenz™ (aH5N1c) is a monovalent, adjuvanted, cell-based inactivated influenza (H5N1) vaccine designed to protect individuals six months of age and older in the event of a 'bird flu' pandemic.

As a reminder, the CDC encourages the proper handling and cooking of all poultry and eggs to an internal temperature of 165 ˚F as a general food safety precaution.

Breaking avian influenza news is posted at PrecisionVaccinations.com/Avian.

Note: This information was manually curated for mobile readers.

May 22, 2022 • 3:43 am CDT
by Ernesto Eslava

The nonprofit scientific research organization IAVI and Massachusetts-based Moderna, Inc. recently announced that a Phase I clinical trial of an mRNA HIV vaccine antigen (mRNA-1644) will soon launch at the Center for Family Health Research (CFHR) in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa.

The IAVI-sponsored trial, IAVI G003, builds on progress in HIV vaccine research.

Recent findings from the Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein safely induced the targeted immune responses in 97% of recipients (healthy U.S. adults).

The immune response — targeting and expanding a specific class of B cells — is needed to develop broadly neutralizing antibodies (bnAbs).

The induction of bnAbs is widely considered a goal of an efficacious HIV vaccine, and this B-cell activation is the first step in that process.

IAVI G003 is designed to test the hypothesis that vaccination with eOD-GT8 60mer, developed by scientific teams at IAVI and Scripps Research, delivered via Moderna's mRNA platform, can induce similar immune responses in African populations as was seen for IAVI G001.

"The road to an HIV vaccine has been long and winding. mRNA technology has the potential to accelerate the development of a safe, effective, affordable, and durable HIV vaccine for use throughout the world," said Mark Feinberg, M.D., Ph.D., president, and CEO of IAVI, in a press statement issued on May 18, 2022.

"IAVI G003 harnesses Moderna's proven mRNA vaccine technology, a novel HIV vaccine approach developed over many years by IAVI and Scripps Research, and more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa."

"Together, we aim to answer critical research questions that can advance HIV vaccine development that increasingly involves leadership by scientists in countries where a vaccine is needed most."

Additional HIV vaccine news is posted at PrecisionVaccinations.com/HIV.

Note: This media statement was manually curated for mobile readership.

May 22, 2022 • 3:13 am CDT
CDC

The U.S. CDC's latest Influenza Surveillance Report indicates pneumonia continues to outpace both COVID-19 and influenza (PIC) as the respiratory disease causing the most fatalities.

On May 19, 2022, the National Center for Health Statistics Mortality Surveillance data shows among the 1,409 PIC deaths reported last week, 790 listed pneumonia as an underlying or contributing cause of death on the death certificate, 592 had COVID-19, and 27 listed influenza.

And as of May 20, 2022, there have been (24) influenza-related pediatric fatalities confirmed during the 2021-2022 flu season.

Last flu season, the CDC confirmed just (1) flu-related pediatric fatality.

Routine administration of all age-appropriate doses of vaccines simultaneously is recommended for children for whom no specific contraindications exist at the time of the visit, says the CDC.

The CDC also reported that most influenza viruses detected during week #18 are A(H3N2), which are genetically related to the current flu shot virus.

Additionally, the CDC says 'individuals can get COVID-19 and flu vaccinations simultaneously.'

From an international perspective, the European CDC reported on May 20, 2022, three countries reported very high seasonal activity: Finland (50%), Slovakia (38%), and the Netherlands (31%).

This is important news since flu shots remain available at most pharmacies in the USA.

Note: This information was manually curated for mobile readers.

May 21, 2022 • 7:14 pm CDT
by Janko Ferlic

According to recent statements by the health minister, the safe and effective cancer prevention vaccine may soon become available free to all women under 25 in Ireland. 

Mr. Donnelly informed the Irish Examiner on May 20, 2022, that he had written to the Health Service Executive (HSE) requesting it to outline a human papillomavirus (HPV) vaccination program for women.

"This is an incredibly effective vaccine, and I would like to see a catch-up program rolled out as quickly as possible," the minister stated.

"We have a number of young women who were offered the HPV vaccine (during COVID-19) and didn't take it at the time."

HSE school vaccination teams had already been working with schools to ensure anyone who missed their shot while in their first year gets a second opportunity.

Furthermore, specific women may only need one HPV vaccine dose.

The National Immunisation Advisory Committee (NIAC) is finalizing its recommendation to reduce the number of HPV vaccinations to just one dose.

The NIAC's action follows similar decisions by the UK Health Security Agency on February 24, 2022. 

Additionally, the HPV vaccination program is changing from Gardasil® to Gardasil®9 in 2022.

Merck's Gardasil9 vaccine helps protect people ages 9 to 45 against cervical, vaginal, and vulvar cancers in females, anal cancer, certain head and neck cancers, and genital warts in both males and females. 

This is an important life-saving program since the Irish Examiner reported in January 2022 that 11% of women screened for HPV by CervicalCheck were found to be positive for the cancer-causing virus.

The Gardasil9 vaccine is generally available at clinics and pharmacies in the USA.

Additional HPV vaccination news is posted at PrecisionVaccinations.com/HPV.

Note: This information was manually edited for clarity and curated for mobile readership.

May 21, 2022 • 2:27 pm CDT
by janeb13

Public Health Agency of Canada (PHAC) announced yesterday an increase in acute severe hepatitis cases in children not caused by known hepatitis viruses. As of May 20, 2022, there are ten cases in Canada meeting the national definition for these mysterious cases.

The breakdown by province is as follows: Alberta (3), Manitoba (2), Ontario (4), and Quebec (1).

These children, who were younger than 13 years old, became sick between November 3, 2021, and April 23, 2022, and were hospitalized.

Two of these children required a liver transplant, but no reported deaths in Canada reported the PHAC.

Separately, the UK Heath Security Agency (UKHSA) published its third detailed technical briefing on the investigations into the increase in cases of sudden onset hepatitis in children.

The total number of pediatric cases in the UK has reached 197 as of May 16, 2022.

Of these mysterious cases, 11 have received a liver transplant, and no patients in the UK have died.

Dr. Meera Chand, Director of Clinical and Emerging Infections at UKHSA, recently commented, 'It's important that parents know the likelihood of their child developing hepatitis is extremely low.'

'Our investigations suggest an association with adenovirus, and our studies are now testing this association rigorously.'

Since this outbreak began in 2019, the UK, Europe, Canada, the USA, and other countries have reported about 624 acute liver inflammation infections of unknown etiology among children, including 14 deaths, in about thirty countries.

Breaking news is posted at PrecisionVaccinations.com/Acute.

Note: This information was manually curated for mobile readers.

May 20, 2022 • 2:02 pm CDT
CDC

The Director of the U.S. CDC confirmed yesterday it is expanding the eligibility of COVID-19 vaccine booster doses to everyone five years of age and older, five months after their initial two-dose Pfizer-BioNTech (Comirnaty) vaccination series.

"Today, I endorsed the Advisory Committee on Immunization Practices (ACIP) vote to expand eligibility for COVID-19 vaccine booster doses," stated Dr. Rochelle P. Walensky in a media statement issued on May 19, 2022.

"With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected."

"I encourage parents to keep their children up to date with CDC's COVID-19 vaccine recommendations."

"With (COVID-19) cases increasing, it is important that all people have the protection they need, which is why, today, CDC has also strengthened another booster recommendation."

"Those 50 and older and 12 and older and immunocompromised should get a second booster dose."

In addition, the CDC announced it is strengthening its recommendation that those 12 and older who are immunocompromised and those 50 and older should receive a second booster, 4th dose, at least four months after their 3rd vaccination.

The ACIP presentation slides for the May 19, 2022, digital meeting are posted at this CDC link.

On May 19, 2022, the CDC reported that about 66.5% of the U.S. population had been 'fully vaccinated' with an Approve/Authorized COVID-19 vaccine.

And about 46.4% of eligible people have been 'first boosted' and are now 'up to date' vaccinated.

Note: This CDC announcement was manually curated for mobile readers.

May 20, 2022 • 1:14 pm CDT
CDC

The U.S. CDC announced today in a Health Advisory the Massachusetts Department of Public Health and the CDC are investigating a confirmed case of monkeypox in the United States.

As announced by Massachusetts on May 17, 2022, the patient was infected with a West African strain of monkeypox virus.

As of May 20, 2022, media sources have reported 'six suspected monkeypox cases in the U.S., including New York City.

Globally, (11) countries, including the United Kingdom, Spain, Sweden, Portugal, Netherlands, Italy, Germany, France, Canada, Belgium, and Australia, have reported monkeypox cases.

The CDC issued today's Health Alert Network Health Advisory CDCHAN-00466 to ask clinicians in the U.S. to be vigilant to the characteristic rash associated with monkeypox.

Lesions may be disseminated or located on the genital or perianal area alone. In addition, some patients may present with proctitis, and their illness could be clinically confused with a sexually transmitted infection like syphilis or herpes or with varicella-zoster virus infection.

Suspicion of a monkeypox infection should be heightened if a rash occurs in people who:

  • traveled to countries with recently confirmed cases of monkeypox,
  • report having had contact with a person or people who have a similar-appearing rash or received a diagnosis of confirmed or suspected monkeypox, or
  • is a man who regularly has close or intimate in-person contact with other men.

According to the CDC, monkeypox is a zoonotic infection endemic to several Central and West African countries.

However, the actual source of the monkeypox virus is unknown.

Before May 2022, monkeypox cases outside of Africa were reported either among people who visited Nigeria or in contact with a person with a confirmed monkeypox virus infection. 

The last cases in the U.S. were confirmed in Texas and Maryland in 2021.

According to the U.S. FDA, the TPOXX antiviral and the Jynneos vaccine are potential therapeutics for controlling a monkeypox outbreak. 

Additional monkeypox outbreak news is posted at Vax-Before-Travel.com/Monkeypox.

Note: The information was manually curated for mobile readers.

May 19, 2022 • 12:12 pm CDT
FDA

New York-based SIGA Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox.

SIGA stated in its press release issued on May 19, 2022, that the IV formulation is an essential option for those unable to swallow the oral capsules of TPOXX.

The oral formulation of TPOXX (tecovirimat) is approved in the U.S., Canada, and Europe.

TPOXX worldwide approvals include the treatment of smallpox, monkeypox, cowpox, and complications from immunization with vaccinia.

Recently, SIGA announced that it had initiated clinical programs to support oral TPOXX label expansion for Post-Exposure Prophylaxis.

And from an availability perspective, SIGA announced on May 12, 2022, that the U.S. Department of Defense (DoD) awarded a contract to SIGA for the procurement of up to approximately $7.5 million of oral TPOXX, of which approximately $3.6 million of oral TPOXX targeted for delivery in 2022.

“We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” commented Dr. Dennis Hruby, CSO of SIGA, in a related media statement

“We are also appreciative to our colleagues at BARDA who have been working with us for many years to include oral and IV TPOXX in U.S. preparedness efforts and look forward to continuing to work with them on our liquid pediatric formulation.”

Smallpox is a contagious, disfiguring, and often deadly disease that has affected humans for thousands of years. And monkeypox is caused by a member of the Orthopoxvirus genus in the family Poxviridae.

As of May 19, 2022, six countries have reported monkeypox cases in May 2022.

Breaking news is posted at Vax-Before-Travel.com/Monkeypox.

Note: The SIGA announcement was edited for clarity and manually curated for mobile readership.

May 19, 2022 • 10:44 am CDT
by Gerd Altmann

The World Health Organization (WHO) announced today it issued an emergency use listing (EUL) for CONVIDECIA, a modified human adenovirus COVID-19 vaccine manufactured by CanSino Biologics.

The eleven COVID-19 vaccines Listed by the WHO are published on this webpage.

CONVIDECIA was assessed under the WHO EUL procedure based on the quality, safety, efficacy, a risk management plan, programmatic suitability, and a manufacturing site inspection conducted by WHO.

CONVIDECIA was recently found to have 64% efficacy against symptomatic disease and 92% against severe COVID-19 in adults.

And the Technical Advisory Group for Emergency Use Listing, convened by WHO and made up of regulatory experts worldwide, has determined that the vaccine meets WHO standards for protection against COVID-19 and that the vaccine's benefits far outweigh the risks.

Additionally, CONVIDECIA was reviewed earlier in May 2022 by WHO's Strategic Advisory Group of Experts on Immunization, which formulates vaccine-specific policies and recommendations for vaccines' use in populations.

The WHO EUL procedure assesses the suitability of novel health products during public health emergencies.

Note: The WHO press release issued on May 19, 2022, was manually curated for mobile readership.

May 19, 2022 • 6:44 am CDT
by Namenibe YOABONE LAMBONI

The U.S. CDC's National Center for Immunization and Respiratory Diseases (NCIRD) recently updated the ongoing investigation of children with acute hepatitis of unknown etiology.

Since October 2021, the NCIRD's data indicates (180) persons under investigation (PUI), with (36) states reporting.

On May 18, 2022, the CDC stated, 'PUI does not mean this person is a confirmed case.'

'While rare, children can still have serious hepatitis, and we don't always know the cause. That's why investigators continue to look at possible causes and investigate.'

'It’s important to understand that the vast majority of these are what we consider ‘retrospective’ patients.'

And, 'The states and CDC are looking broadly, so these numbers may go up or down as medical charts are reviewed, and we learn more.'

The CDC's reported PUIs are preliminary and subject to change as more data become available. Additionally, numbers for each state will not be released to protect patient privacy.

There is no known association between hepatitis viruses (A to E) with serum transaminases greater than 500 IU/l in these children.

Separately, the U.K. and Europe continue reporting adenovirus-related acute hepatitis cases in children who are generally COVID-19 unvaccinated.

About 11% were recently infected with the SARS-CoV-2 virus.

This updated information is posted at PrecisionVaccinations.com/Acute.

Note: This CDC announcement was edited for clarity and manually curated for mobile readers.

May 18, 2022 • 3:18 pm CDT
by Gerd Altmann

Denmark-based Bavarian Nordic A/S announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised the first options under an existing contract to supply a freeze-dried version of the JYNNEOS® smallpox vaccine.

The first doses of this vaccine version will be manufactured and invoiced in 2023 and 2024. 

If exercised, additional options on the BARDA contract support the conversion of up to a total of approximately 13 million freeze-dried doses of JYNNEOS smallpox vaccine that are expected to be manufactured in 2024 and 2025.

The majority of the bulk vaccine for these doses has already been manufactured.

A supplement to the existing liquid frozen JYNNEOS U.S. FDA BLA will be made comprising Phase 3 clinical study data, which has already been completed and reported, together with the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024.

Paul Chaplin, President and CEO of Bavarian Nordic, commented in today's press release, "We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility."

"This marks a significant milestone in our long-standing partnership with the U.S. government to ensure availability of life-saving vaccines for the entire population."

Jynneos is based on a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), incapable of replicating in the human body yet able to elicit a potent immune response. 

To protect people from monkeypox, the Jynneos vaccine was approved by the U.S. FDA in 2019.

Jynneos (Imvamune or Imvanex) was also approved by the European Medicines Agency in 2013 and is indicated for preventing smallpox and monkeypox disease in adults.

Additional monkeypox outbreak news is posted at Vax-Before-Travel.

Note: This announcement was manually curated for mobile readers.