Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Nov 21, 2022 • 10:17 am CST
U.S. CDC

The U.S. CDC recently reported a decreasing rate of new monkeypox virus (PMXV) infections in the U.S.

As of November 18, 2022, the CDC reported the seven-day moving average of new MPXV cases was 13.

Overall, the CDC has confirmed 29,133 Total Cases and 12 related fatalities since May 2022.

Similarly, the number of new vaccinations has also decreased.

Since beginning vaccinations in July 2022 with the JYNNEOS® (MVA-BN, IMVANEX®) vaccine, the Total Number of first and second doses has recently averaged about 4,400 per week.

According to the latest data from the U.S. Administration for Strategic Preparedness and Response, should this positive trend reverse, plenty of JYNNEOS vaccines should be available to meet demand.

Additional vaccine information is posted at PrecisionVaccinations.com/Monkeypox.

Nov 21, 2022 • 6:07 am CST
C.S. Mott Children’s Hospital

Most children have a primary care provider that offers guidance on how parents can support their child’s immune system development. 

Vaccinations are a frequent topic of discussion.

However, according to a C.S. Mott Children’s Hospital National Poll published on November 21, 2022, most parents say they discuss vaccines needed for school (82%) and less often flu vaccine (68%) or COVID vaccine (57%).

And about 15% of parents say they did not discuss any vaccines with their child’s primary care provider.

Some parents report talking only with other health professionals, such as pharmacists or nurses, about school vaccines (4%), flu vaccines (8%), or COVID vaccine (14%).

Six percent of parents report that their child does not get any vaccines.

Among these parents, 43% report no vaccine discussions with any healthcare provider in the past two years.

Among parents who discussed vaccines with their child’s regular doctor, 80% said the doctor was open to their questions and concerns.

Nov 21, 2022 • 5:50 am CST
by Craig Clark

Novavax, Inc. recently announced that Health Canada had granted expanded authorization for Nuvaxovid™ for active immunization to prevent COVID-19 as a homologous booster in adults.

"Canadians now have access to our protein-based Nuvaxovid COVID-19 vaccine as an adult booster," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on November 18, 2022. 

"With the winter months upon us, it's important to have options for vaccination to help protect against COVID-19."

Novavax's vaccine (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) has been authorized as a heterologous and homologous booster in the U.S., European Union, United Kingdom, Japan, Australia, New Zealand, and Switzerland, as well as several other countries.

Novavax has ongoing trials to explore further the vaccine's immunogenicity and safety as a heterologous booster.

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

Nov 20, 2022 • 6:15 am CST
U.S. CDC

With $86 million in funding this year, a privately held clinical-stage biotechnology company aspires to disrupt the $3 billion shingles vaccination market with a safer vaccine.

"Completing this A1 round ($26 million) ahead of data from our Phase 2b trial of CRV-101 head-to-head against Shingrix® is a meaningful demonstration of the confidence our investors have in the CRV-101 program," said George Simeon, Curevo Vaccine CEO, in a press release on November 16, 2022.

"The $86 million we raised in 2022 significantly extends our cash runway and allows us to more aggressively pursue our programs; we look forward to getting topline data from the Phase 2b shingles trial in early 2023."

CRV-101 is a clinical-stage adjuvanted sub-unit vaccine under investigation to prevent shingles in older adults.

CRV-101 was specifically designed to produce an optimal immune response while using a smaller amount of adjuvant with the intention of achieving similar efficacy but with fewer side effects than the currently-approved shingles vaccine.

In the Phase 1 program, CRV-101 demonstrated very robust immunogenicity as measured by humoral and cellular responses with no grade 3 injection site reactions and a low (1.3%) rate of grade 3 systemic side effects ("grade 3" side effects are those vaccination-related reactions severe enough to prevent normal activities).

According to the U.S. CDC website, about 1 in 6 patients receiving the Shingrix® vaccine experienced side effects preventing them from participating in regular activities. However, side effects usually go away after a few days. 

Andy Acker, Portfolio Manager at Janus Henderson Investors, commented, "We were impressed with the Curevo team's execution of the Phase 2b trial, including enrolling 678 patients in just six months, and are looking forward to the results."

If you've had chickenpox, you are at risk for shingles. Shingles is a painful blistering skin rash caused by a reactivation of the varicella-zoster virus, says the CDC.

About 10% of people with shingles develop nerve pain called postherpetic neuralgia (PHN), which can last for months or even years after the rash disappears.

The pain from PHN can be so severe and debilitating that it interferes with daily life.

Other shingles vaccine news is posted at PrecisionVaccinations.com/Shingles.

Nov 19, 2022 • 6:13 am CST
by Bruno P.

The peer-review journal The Lancet Infectious Disease published the findings from an analysis that reviewed Omicron sublineage BQ.1.1 resistance to monoclonal antibodies (mAbs).

Our data revealed on November 18, 2022, indicates emerging omicron sublineages are resistant to most (i.e., BA.4.6, BA.2.75.2, and BJ.1) or all (BQ.1.1) clinically used mAbs.

Consequently, in patients at high risk, treatment with mAbs alone might not provide a therapeutic benefit in regions of the world where BQ.1.1 is spreading.

This finding suggests that additional treatment options (paxlovid) should be considered.

Furthermore, novel, broadly active mAbs are urgently needed for prophylactic or therapeutic treatment, or both, in high-risk patients.

Other news regarding U.S. FDA mAbs is posted at PrecisionVaccinations.com/Antibody.

Nov 18, 2022 • 4:06 am CST
by Andreas P.

The Colchester Hospital in Essex, England, confirmed yesterday it had an "infection control issue" after a patient's viral symptoms and recent travel history elevated concerns of a Sudan Ebolavirus (SUDV) exposure among medical staff.

Dr. Meera Chand, UK Health Security Agency (UKHSA) director of clinical and emerging infection, informed local media, "Individuals who have traveled recently and report illness are routinely assessed by NHS clinicians for a variety of infectious diseases."

The UKHSA recently followed the U.S. government's lead in screening travelers from the Republic of Uganda, where a SUDV outbreak has been ongoing since late September 2022.

As of November 18, 2022, over 50 fatalities have been confirmed, including healthcare staff.

While there are U.S. FDA-approved vaccines for the Zaire version of Ebolavirus, the SUDV vaccine development efforts are just launching.

Other Ebola vaccine news is posted at PrecisionVaccinations.com/Ebola.

Nov 17, 2022 • 3:26 pm CST
by Jill Wellington

The United States Department of Agriculture Animal and Plant Health Inspection Service website recently confirmed Minnesota's latest highly pathogenic avian influenza (HPAI) case involved another commercial turkey farm in Otter Tail County involving 30,000 turkeys.

According to reporting by Roy Graber on November 16, 2022, this is the seventh HPAI outbreak in Otter Tail County in 2022.

It also marks the 78th case of HPAI in commercial poultry in Minnesota.

South Dakota ranks second with 44 cases of commercial poultry.

Since the Eurasian H5N1 strain first appeared in North America in January 2022, HAPI outbreaks have led to the loss of about 50 million birds in 46 states as of November 16, 2022.

The U.S. CDC says these are the first detections of HPAI A(H5) viruses in the U.S. since 2016.

Avian influenza (Bird Flu) is a disease caused by influenza type A viruses that occur naturally among birds and domestic poultry.

Since 2003, multiple countries have reported more than 860 human infections with HPAI A(H5N1) viruses to the World Health Organization, with about 53% of those cases resulting in fatalities. 

The CDC says the annual flu shot does not protect people from a HAPI infection, but the U.S. government has prepared pandemic influenza vaccines for use in case of an emergency.

Additional avian influenza vaccine information is posted at PrecisionVaccinations.com/AvianInfluenza.

Nov 17, 2022 • 2:29 pm CST
by Gerd Altmann

Recently, a World Health Organization committee unanimously agreed that the risk of the international spread of poliovirus remains a Public Health Emergency of International Concern.

In response, an editorial written by Aidan O'Leary, Director of the Global Polio Eradication Initiative, clearly articulates why now is the best time to eradicate polio finally.

Recent high-profile detections of poliovirus transmission in the U.K., the U.S., and Israel are, of course, concerning, and such transmission events must be (and are being) appropriately managed.

But what do they mean for the global effort to eradicate polio?

They are clear warnings, giving us a glimpse of what would happen were we not to achieve our shared goal of global polio eradication.

O'Leary's full editorial, published in Internal Health on November 7, 2022, is posted here.

And in New York, Gabby Deutch wrote on November 11, 2022, "We can detect it in the sewage, and indeed, in five counties across many, many months, we've been continually detecting poliovirus up until right this month," said Eli Rosenberg, deputy director for science in the office of public health at the New York State Department of Health.

"We have ongoing evidence of circulation in the community, and that means it's essentially a matter of time until we see more paralytic cases."

But with various polio vaccines readily available, new strategies are needed. 

Some countries use a version of the oral polio vaccine that exposes recipients to the live virus, which on rare occasions, allows the virus to spread.

Since 2000, IPV has been the only polio vaccine available in the U.S.

"There's an understanding of the need to shift to the community level because, from the top down is not working."

"We need to connect with people across every spectrum and the entire nation at a level that resonates with each community."

Additional polio outbreak 2022 news is posted at PrecisionVaccinations.com/Polio.

Nov 17, 2022 • 1:54 pm CST
NYC.gov

With monkeypox virus (MPX) cases down from the peak in late July 2022, both New York City and New York state governments are abruptly ending their emergencies.

New York joins the city of San Francisco, which discontinued its MPX emergency on October 27, 2022.

Dr. Ted Long, SVP at New York City Health + Hospitals informed the New York Times on November 17, 2022, he was working on a proposal to bring back the vaccination vans.

New York's governor had recently extended the Declaration of a Statewide Disaster Emergency on September 27, 2022.

The good news is MPX cases have significantly decreased in NYC.

As of November 7, 2022, NYC Health disclosed there were 3,758 confirmed MPX cases since May 2022.

And there is an ample supply of the two-dose JYNNEOS® (MVA-BN) vaccine.

NYC's total number of vaccinations is about 149,644, split between first doses (2/3) and second doses.

As of November 15, 2022, 1,090,222 JYNENOS doses has administered in 57 U.S. Jurisdictions, with approximately 628,000 persons receiving ≥1 dose and 390,000 persons receiving the complete 2-dose series.

About 854,713 vials were distributed by the U.S. government.

As of November 2022, Jynneos is the only U.S. FDA-approved monkeypox vaccine for U.S. military and civilian use, but it is not sold commercially.

Regarding the vaccine's efficacy, there remains limited research showing how well JYNNEOS works against this version of MPX.

Additional monkeypox vaccine information is posted at PrecisionVaccinations.com/Monkeypox.

Nov 15, 2022 • 3:20 pm CST
from Pixabay

Inventprise recently announced that a first-in-human Phase 1/2 clinical study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) has begun in Halifax, Canada. 

This vaccine candidate is designed to prevent pneumococcal disease caused by serotypes not covered in the current vaccines.

The Phase 1 portion of the study now underway will enroll healthy adult volunteers and use an authorized adult 20-valent PCV as the comparator.

Satisfactory Phase 1 results will trigger Phase 2, which will evaluate the IVT PCV-25, first in young children and then, pending satisfactory data, in infants.

Phase 2 will use an authorized infant 13-valent PCV as the comparator.

“This Phase 1/2 study is important to determine how IVT PCV-25 performs in people and will inform decisions around the vaccine’s progression into later-stage clinical development,” says Dr. Joanne Langley, the study’s principal investigator, in a press release on November 10, 2022.

“If studies show that the vaccine can safely protect against more types of pneumococcal disease, it could be a meaningful tool in the fight against pneumonia—the long-reigning leading cause of child death due to infectious disease in the world.”

Sponsored by Inventprise and conducted in collaboration with the international nonprofit organization PATH and the Canadian Immunization Research Network.

Additional pneumococcal vaccine information is posted at PrecisionVaccinations.com/Pneumococcal.

Nov 15, 2022 • 2:02 am CST
WDD

Catching the seasonal flu can be dangerous for anyone, but it is extra risky for people with diabetes.

In general, every person with diabetes can reduce their health risk with annual influenza vaccination, says the U.S. CDC.

Having diabetes increases the number of instances of high blood glucose, which hinders your white blood cells' ability to fight infections, such as the flu or pneumonia.

This recommendation is especially relevant when celebrating World Diabetes Day on November 14, 2022.

About 10% of adults around the world currently live with diabetes. 

But, unfortunately, most do not know they have it. 

Therefore, the CDC's flu shot recommendation can benefit many undiagnosed diabetics.

Various flu vaccines are available in 2022 and offered at most clinics and pharmacies.

World Diabetes Day was created in 1991 in response to growing concerns about the escalating health threat posed by diabetes. It's the world's most extensive diabetes awareness campaign reaching a global audience of over 1 billion people in more than 160 countries.

Nov 14, 2022 • 11:43 am CST
by Bruno G.

Appili Therapeutics Inc. today announced that the U.S. Department of Defense would provide at least US$14 million in funding over two years to fund the development of the ATI-1701 vaccine candidate to combat Francisella tularensis.

This funding represents a 40% increase over the original US$10 million program announced in February 2022. 

Classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, Francisella tularensis poses the highest risk to national security and public health.

The bacterium Francisella tularensis is found in animals (especially rodents, rabbits, and hares) and causes Tularemia, a potentially serious illness.

Tularemia is not known to be spread from person to person, says the U.S. CDC.

However, people who inhale the bacteria can experience severe respiratory illness.

Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorism attack.

“This funding is expected to strengthen Appili’s foundation in infectious disease and biodefense,” said Dr. Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO, in a press release on November 14, 2022.

The company stated several countries might have operational programs leveraging this pathogen.

Earlier in 2022, Appili announced positive one-year results from its preclinical study evaluating the efficacy of ATI-1701 in a lethal animal model of Tularemia.

A one-year survival rate of 29% (n = 2/7) was reported in the ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock vaccinated controls.

The positive data built on previously reported efficacy results observed at 28- and 90-day challenge time points where there was 100% survival of ATI-1701 vaccinated animals at the 90-day challenge timepoint.

These data position ATI-1701 to potentially become the first approved vaccine for the prevention of Tularemia.

Appili owns the commercial rights to ATI-1701.

Nov 14, 2022 • 10:02 am CST
from Pixabay

After the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for VidPrevtyn® Beta, the European Commission (EC) approved the vaccine on November 10, 2022, as a booster for the prevention of COVID-19 in adults.

VidPrevtyn Beta is indicated as a booster for active immunization against SARS-CoV-2 in adults who have previously received an mRNA or adenoviral COVID vaccine.

Next-generation COVID-19 vaccines are based on a variant-adapted approach, using a strain other than the parental strain of SARS-CoV-2 (D614 strain).

In the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder.

And GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.

Designed to provide broad protection against multiple coronavirus variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSK's pandemic adjuvant.

Thomas Triomphe, EVP, Vaccines, Sanofi, commented in a related press release, "Today's (EC) approval validates our research in developing a novel solution for the COVID-19 pandemic."

"As we're ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19."

VidPrevtyn Beta is a monovalent, recombinant-protein COVID-19 vaccine developed by Sanofi, modeled on the Beta variant.

The companies announced on June 13, 2022, in the Phase 3 VAT02 Cohort 2 study, the vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody titers above baseline against multiple variants of concern (15-fold increase against D614 parent virus, 30-fold increase against Beta strain) in adults previously primed with mRNA COVID-19 vaccines.

In particular, against Omicron, preliminary data show a 40-fold increase against BA.1. 

Shipments of VidPrevtyn Beta to European countries are expected in late 2022.

Nov 14, 2022 • 9:17 am CST
by Marcin P.

The U.S. Centers for Disease Control and Prevention recently reported a rapid increase in the circulation of certain SARS-CoV-2 Omicron subvariants that are likely to be resistant to currently used anti-SARS-CoV-2 monoclonal antibodies (mAbs).

The subvariants BQ.1 and BQ.1.1 are likely resistant to bebtelovimab.

And the subvariants BA.4.6, BA.2.75.2, BA.5.2.6, BF.7, BQ.1, and BQ.1.1 are likely to be resistant to tixagevimab plus cilgavimab (Evusheld).

The anticipated loss of susceptibility is based on in vitro neutralization studies.

In this U.S. NIH statement issued on November 10, 2022, the COVID-19 Treatment Guidelines Panel provides interim recommendations for using bebtelovimab or Evusheld.

Other mAbs news is posted at PrecisionVaccinations/COVID-19.

Nov 14, 2022 • 5:16 am CST
by Alterio Felines

The Columbus Public Health (CPH) and Franklin County Public Health (FCPH) recently confirmed they are investigating a measles outbreak associated with a local childcare facility.

Currently, there are four confirmed cases, all in unvaccinated children with no travel history. 

These four new measles cases bring the total number of confirmed measles cases in Franklin County to eight since June 16, 2022.

According to the U.S. CDC, measles outbreaks can happen in areas where people may be unvaccinated or under-vaccinated.

As of October 28, 2022, a total of 33 measles cases had been reported by five jurisdictions to the CDC.

“We are working diligently with the cases to identify any potential exposures and to notify people who were exposed,” said Columbus Public Health Commissioner Dr. Mysheika Roberts in a press release on November 9, 2022.

“The most important thing you can do to protect against measles is to get vaccinated with the measles-mumps-rubella vaccine, which is safe and highly effective.”

Measles can enter the U.S. through infected travelers entering or traveling through the U.S. and infected U.S. travelers returning from other countries.

As of November 14, 2022, measles outbreaks are occurring in every region of the world, led by India and various African and Asia countries.

Measles vaccines are commonly available at most clinics and pharmacies in the U.S.