Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Sep 24, 2021 • 7:07 am CDT

The Centers for Disease Control and Prevention Director Dr. Rochelle Walensky approved most of the recommendations from the Advisory Committee on Immunization Practices (ACIP) late on September 23, 2021.

During a two-day meeting, the ACIP doctor-advisers said boosters should be offered to people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying health problems, reported NPR.

The third dose of the two-dose Pfizer-BioNTech (Comirnaty) vaccine would be given once they are at least six months past.

Dr. Walensky and the ACIP only authorized the Comirnaty vaccine, but not U.S. FDA Authorized Moderna's SpikeVax or Johnson & Johnson Janssen COVID-19 vaccine for an extra booster.

"As CDC Director, it is my job to recognize where our actions can have the greatest impact," Walensky said in a statement late Thursday night.

"At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good."

The ACIP and U.S. FDA committees included data from Israel on its 3rd vaccination program, which launched just a few weeks ago, with minimal data on the younger cohort.

The ACIP committee reviewed various risks and benefits regarding a 3rd booster dose of the Comirnaty vaccine for specific populations during Sara Oliver, M.D., MSPH, presentation: 'Evidence to Recommendation Framework.'

The U.S. Advisory Committee on Immunization Practices comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population. Once they are approved or not by the CDC Director and Department of Health and Human Services, recommendations are published in the CDC's MMWR. The MMWR publication represents the official CDC recommendations for immunizations of the U.S. population.

Sep 23, 2021 • 6:52 am CDT

New York-based Codagenix Inc. announced on September 22, 2021, that their novel intranasal COVI-VAC vaccine had demonstrated promising safety and immunogenicity results in their Phase 1 dose-escalation clinical trial in healthy adults.

Data indicate that COVI-VAC is likely to block replication of the SARS-CoV-2 virus in the nose. This is a unique attribute of an intranasally delivered vaccine, says Codagenic.

These clinical data, combined with preclinical data showing COVI-VAC to be efficacious against a SARS-CoV-2 virus variant of concern, suggest the vaccine has the potential to generate broad immunity against COVID-19.

COVI-VAC is a live-attenuated vaccine candidate developed using Codagenix's machine-learning enabled codon deoptimization vaccine design platform, which relies on a combination of computational science and synthetic biology to produce systematically attenuated viral vaccines.

These rationally designed viral vaccines are an antigenic match to all the proteins of the target virus, not just the spike protein, making them capable of stimulating a complete, robust humoral and cell-mediated immune response.

"The topline safety and immunogenicity data generated in our Phase 1 trial are highly encouraging and demonstrate potential for a live-attenuated vaccine that is safe, immunogenic and uniquely capable of blocking nasal replication of the virus," commented J. Robert Coleman, Ph.D., M.B.A., Co-Founder and CEO of Codagenix, in a press statement.

"Our vaccine candidate appears able to block surrogate SARS-CoV-2 replication in the nose before it reaches the lower airways or lungs."

"This is likely achieved by stimulating both a systemic and mucosal immune response, highlighting the value of an intranasal, live-attenuated vaccine model."

"These data clearly support our ongoing acceleration into Phase 2/3 trials, and we look forward to advancing COVI-VAC as a contributor in the continuing global fight against COVID-19."

Codagenix is a clinical-stage biotechnology company located in Farmingdale, NY, whose committed vision is to build the world's most agile, adaptable, and powerful vaccine platform, protecting us from threats and incurable diseases today and for generations to come. 

Sep 23, 2021 • 5:37 am CDT

France-based Valneva SE announced today that it had commenced recruitment of adolescents in the United Kingdom for its pivotal Phase 3 Clinical Trial (Cov-Compare") for its inactivated COVID-19 vaccine candidate VLA2001.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

This COVID-19 vaccine candidate is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, including addressing new SARS-CoV-2 betacoronavirus variants. 

Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial.

This planned expansion of VLA2001 clinical trials will support future approval in other age groups, in addition to adults.

A further expansion of the clinical study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

Valneva has also commenced booster vaccinations as a continuation of the Phase 1/2 VLA2001-201 trial. The booster shot will be provided to each volunteer six months after the initial vaccination.

Thomas Lingelbach, CEO of Valneva, commented in a press release, "Our teams at Valneva remain fully committed to carry out VLA2001's development plan and bring our inactivated vaccine to all patient groups who could benefit."

"We continue to receive messages on a daily basis from people across the world who are waiting for an inactivated vaccine, so we continue to believe that our differentiated vaccine candidate could contribute to the ongoing fight against the COVID-19 pandemic."

"We're confident that many countries, and regulators, will want to have the opportunity to consider our inactivated COVID-19 vaccine." 

Valneva is conducting several clinical trials of VLA2001.

In addition to Cov-Compare and VLA2001-201, VLA2001 is being evaluated in elderly volunteers in study VLA2001-304 in New Zealand and a small, policy-led trial sponsored by University Hospital Southampton NHS Foundation Trust, which is not part of Valneva's regulatory package.

Valneva continues discussions with the European Commission regarding a potential VLA2001 supply contract. The Company is also actively pursuing opportunities to make VLA2001 available to other customers, subject to positive Cov-Compare data and regulatory approval.

Valneva is a specialty vaccine company located in Saint-Herblain, France, focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need. 

Sep 22, 2021 • 7:29 pm CDT

The U.S. Food and Drug Administration (FDA) announced it amended the emergency use authorization (EUA) for the Pfizer-BioNTech Comirnaty COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series.

This third does of the Comirnaty vaccine is Authorized at least six months following completion of their primary series for:

  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19; and 
  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to the SARS-CoV-2 coronavirus puts them at high risk of serious complications of COVID-19.

Today's FDA Authorization was granted to Pfizer Inc. and applied only to the two-dose Pfizer-BioNTech Comirnaty COVID-19 Vaccine and not the Moderna SpikeVax or Johnson & Johnson Janssen vaccines.

The FDA considered the data that the vaccine manufacturer submitted, the information presented at the Vaccines and Related Biological Products Advisory Committee meeting, and the committee's discussion, and has determined that based on the totality of the available scientific evidence, a booster 3rd dose of Pfizer-BioNTech Comirnaty COVID-19 Vaccine may be effective in preventing COVID-19.

And that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.

Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months, stated the FDA.

Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, stated in the press release, "The FDA considered the committee's input and conducted its own thorough review of the submitted data to reach today's decision."

"We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines, and we will make further decisions as appropriate based on the data." 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

Sep 22, 2021 • 9:59 am CDT

On September 22, 2021, William C. Gruber, M.D., Senior Vice President Vaccine Clinical Research and Development Pfizer Inc., presented an updated 3rd dose (booster) analysis regarding the Comirnaty COVID-19 vaccine to the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) digital meeting on September 22, 2021.

The highlights from this Pfizer presentation are as follow:

  • Data from Israel and the United States suggest vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.
  • Comirnaty-elicited Sera Effectively Neutralize a Broad Range of SARS-CoV-2 Spike Variants After 2 Doses.
  • Post-dose 3 BNT162b2 GMTs Indicate a Substantial Boost and Reduced Gap Between W.T. and Beta Neutralization.
  • Geometric Mean Ratio of Neutralization Titers Non-inferiority Criterion (Post-dose 3 vs. Post-dose 2) was Met, with Titers ~3-fold Higher.
  • Safety and Immunogenicity Data Meet FDA Criteria for Booster Dose ≥16 Years of Age.

In summary, Pfizer indicated 'Comirnaty (BNT162b2) demonstrated high efficacy (>90%) against COVID-19 and safety in the pivotal clinical trial after a 2-dose primary series. And while Vaccine Efficacy against severe disease and hospitalization remains high in most populations in the U.S., data from Israel predicts this may not be sustained.'

Israel has administered over 3.1 million 3rd vaccine doses since late July 2021 through today. Israel's COVID-19 data dashboard is available at this link.

The U.S. FDA issued Approval to BioNTech Manufacturing GmbH for Comirnaty on August 23, 2021. The Comirnaty vaccine is Approved for additional people, including individuals 12 through 15 years of age, and for administering the third dose in specific immunocompromised individuals.

The initial agenda of the ACIP meeting to review COVID-19 vaccines was published on Sept 20th.

Sep 21, 2021 • 4:50 pm CDT

The US Centers for Disease Control and Prevention (CDC) issued a Health Advisory on September 20, 2021, that recommends clinicians be on alert for cases of measles that meet the case definition, as well as other infectious diseases, including mumps, leishmaniasis, and malaria, among evacuees from Afghanistan.

This high-level Health Alert Network Advisory includes both Afghan nationals and U.S. citizens.

Measles is a highly contagious infectious disease. Around 90% of people who are close contacts and not protected will become following infected exposure to the measles virus.

Evacuees in the USA are required to be vaccinated and complete a 21-day quarantine from the time of measles vaccination at U.S. “Safe Haven” designated locations, such as military bases.

Some evacuees left bases before measles cases were identified, and a mass vaccination campaign began. In addition, some evacuees who arrived in the United States early in the repatriation and resettlement process were transported to locations other than the current eight bases for temporary housing.

Clinicians should immediately notify their local or state health department of any suspected cases of measles. Clinicians should also recommend the measles, mumps, and rubella (MMR) vaccine for unvaccinated patients.

However, live vaccines administered to a pregnant woman pose a theoretical risk to the fetus.

Therefore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy.

Persons at risk of severe disease and/or complications from measles should receive immunoglobulin, says the CDC.

In addition to MMR vaccination, CDC recommends that evacuees are also up to date on vaccinations for varicella, polio, COVID-19, and seasonal influenza.

As of September 20, 2021, CDC has been notified of 16 confirmed measles cases and four cases of mumps among Afghan nationals and U.S. citizens recently arriving from Afghanistan, and continued vigilance is needed.

The CDC's measles outbreak list as of August 13, 2021, shows the countries of Nigeria (6,170), Pakistan (6,032), and Afghanistan (1,273) reporting measles cases in 2021.

And recently, the PAHO reported on September 11, 2021, there have been 578 confirmed measles cases in 2021. 

The US Department of Health and Human Services issues HAN Message. A Health Alert conveys the highest level of importance; warrants immediate action or attention.

Sep 21, 2021 • 3:45 pm CDT

New Jersey-based Johnson & Johnson announced new data today from a non-peer-reviewed phase 3 study reinforcing the strong and long-lasting protection of its Janssen COVID-19 vaccine. Recent data also showed that protection against COVID-19 increases when a booster 2nd shot is administered.

Moreover, the safety profile of the Janssen COVID-19 vaccine remained consistent and was generally well-tolerated when administered as a booster.

“Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, in a press release.

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.”

The Company has provided available data to the U.S. FDA. In addition, it plans to submit the data to other regulators, the World Health Organization, and National Immunization Technical Advisory Groups worldwide to inform decision-making on local vaccine administration strategies, as needed.

Additionally, in the largest real-world evidence Vaccine Effectiveness (VE) study of participants receiving the Johnson & Johnson single-shot Janssen COVID-19 vaccine in the USA to date, the Janssen R&D Data Science team, Harvard University, and Aetion utilized the HealthVerity database to compare approximately 390,000 people who received the Company’s single-shot COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity.

In the real-world data, the Johnson & Johnson single-shot COVID-19 vaccine showed a VE of 81% (CI, 79%-84%) for COVID-19-related hospitalizations and an effectiveness of 79% (CI, 77%-80%) for COVID-19-related infections. The uncorrected VE was 69% (CI, 67%-71%) for COVID-19-related infections; VE of 73% (CI, 69%-76%) for COVID-19 hospitalizations.

The Johnson & Johnson single-shot COVID-19 vaccine showed VE against COVID-19-related hospitalizations at 86% (CI, 83%-89%) for participants younger than 60 years and 78% (CI, 74%-81%) for those 60 years and older.

VE against COVID-19 infections was 81% (CI, 79%-82%) for people younger than 60 years and 75% (CI, 73%-78%) for those 60 years and older.

These results are consistent with what was observed in the ENSEMBLE study, said the Company.

The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Learn more at www.jnj.com and www.janssen.com.

Sep 21, 2021 • 2:10 pm CDT

The draft agenda of the Advisory Committee on Immunization Practices (ACIP) digital meeting to review COVID-19 vaccines was published. This two-day ACIP meeting is scheduled for September 22, 2021, 10:00 a.m. – 4:30 p.m., and September 23, 2021, 12:00 p.m. – 3:30 p.m. ET.

The sessions and presentation for Wednesday are scheduled to discuss, but are not limited to, the following topics:

  • Safety and immunogenicity for the 3rd dose of (Comirnaty) BNT162b2 Immunity and SARS-CoV-2.
  • Vaccine effectiveness studies in the United States.
  • Modeling the potential impact of booster doses in nursing home residents.
  • Early safety monitoring for third doses of mRNA vaccines.
  • VaST summary Work Group summary.
  • Pregnancy: Safety monitoring in v-safe.
  • Pregnancy: Safety monitoring in VSD.
  • Updates on COVID-19 and pregnancy.

Any interested person who wishes to make an oral public comment during an ACIP meeting should submit a request with the U.S. CDC before the meeting according to the instructions in the Federal Register Notice. The ACIP Secretariat can be contacted at 1600 Clifton Road, N.E., Mailstop A27, Atlanta, GA 30329-4027 or [email protected]

The Advisory Committee on Immunization Practices webcast will be activated at this link.

Note: This post was updated on September 22, 2021.

Sep 21, 2021 • 1:40 pm CDT

People who have received an organ transplant are at high risk for contracting COVID-19 and becoming severely sick, stated a press release issued by the Feinstein Institutes for Medical Research.

And after receiving a transplanted organ, immunosuppressive drugs may interfere with the recipient’s ability to build a strong immune defense against the SARS-CoV-2 betacoronavirus from the first doses of a COVID-19 vaccine.

A new multi-centered, nationwide phase 3 clinical trial is looking at the efficacy of a third Moderna SpikeVax vaccine dose for COVID-19 in people living with an organ (liver or kidney) transplant.

The Feinstein Institutes administered an extra vaccine to the first set of patients in the United States on September 20, 2021. This trial will dose patients with an extra shot and monitor their immune antibody response 28 days from the third shot.

“Organ transplant recipients may not have as strong of an immune response to the COVID-19 vaccines as the general population does, leaving them vulnerable to the virus,” said Lewis Teperman, M.D., director of transplant services for Northwell Health and principal investigator on the trial, in a related press release.

“We are eager to provide patients more vaccine to help protect them and to gain much-needed scientific evidence to help doctors best treat their patients.”

People who have received a solid organ transplant within the last six months may qualify for the trial. Moderna is hoping 240 participants (including healthy volunteers) will be enrolled in the trial nationwide. The Feinstein Institutes is one of the seven sites leading the trial and the first to enroll participants.

In March 2020, the Feinstein Institutes announced its first clinical trials focused on studying the safety and efficacy of potential COVID-19 therapies. Since then, Feinstein Institutes initiated more than 17 clinical trials and programs and enrolled more than 1,800 patients.

Most recently, the Feinstein Institutes began to enroll patients in another national clinical trial that delivers extra vaccinations to patients with an autoimmune disease. Researchers will investigate whether antibody response to the vaccine is related to medications, disease, and/or vaccine type.

Long Island-based Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State.

Note: August 25, 2021, Moderna, Inc. announced it had completed the rolling submission process for its Biologics License Application to the U.S. FDA for the full licensure of the SpikeVax COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older. 

Sep 21, 2021 • 11:23 am CDT

Florida Governor Ron D. DeSantis Tweeted late on September 20, 2021, 'Since Florida opened monoclonal antibody (mAbs) treatment sites in August, 100,000 Floridians have received treatments and COVID-19 hospital admissions have fallen by over 60%.'

And, 'COVID hospital census has declined for 28 consecutive days, with COVID-19 related ER visits declining by over 70%.'

However, the 46th Governor of Florida continued Tweeting by stating, 'Florida’s treatments (have recently been) cut by more than 50%.'

This reduction is counter to Florida's Board of Medicine decision to support mAbs treatments on August 5, 2021.

Governor DeSantis's concerns are related to the U.S. Department of Health and Human Services' (HHS) decision to issue a Public Health Emergency update of September 13, 2021, announcing a revised State/territory-coordinated distribution system for Monoclonal Antibody Therapeutics.

Monoclonal antibodies that target the spike protein have shown clinical benefits in treating SARS-CoV-2 coronavirus infection.

HHS stated 'it had transitioned away from a direct ordering process products from AmerisourceBergen. And transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.'

In the future, 'HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization.'

HHS published mABS distributions for the week of September 13, 2021, at this link.

To address potential mAbs treatment access issues, the following investigational monoclonal antibody therapies are now available under U.S. FDA emergency use authorization (EUA):

  • Casirivimab and imdevimab, administered together (EUA issued November 21, 2020, latest update July 30, 2021)
  • Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021)
  • Sotrovimab (EUA issued May 26, 2021)
  • Tocilizumab (EUA issued June 24, 2021)

The FDA's EUA authorized the use of these mAbs therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply: the patient has a positive COVID-19 test result, or the patient is at high risk for progressing to severe COVID-19, hospitalization, or both.'

Furthermore, the U.S. CDC published information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

The Miami Herald reported on September 20th, Tampa General Hospital CEO John Couris said he’s not happy with the decision to ship Florida fewer doses of mAbs treatments than the state has requested.

“I don’t know why they did it, because the supply chain was working perfectly the way it was,” Couris said before the Florida House Pandemics and Public Emergencies Committee.

“This change is going to hurt people in Florida."

"It’s already starting to make us, for example, think about how we are going to have to limit the hours of operations associated with our ability to provide this life-saving therapy.”

Note: The UK's Medicines and Healthcare products Regulatory Agency Approved the REGEN-COV treatment in August 2021. And the European Medicines Agency began its rolling review onmAbs in January 2021.

Sep 20, 2021 • 5:22 pm CDT

Despite progress in developing innovative vaccines against the SARS-CoV-2 coronavirus, there is a need to validate vaccine platforms for broader application, stated Navin Varadarajan, M.D., University of Houston, M.D. Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, in a related article.

The current intramuscular vaccines are designed to elicit systemic immunity without conferring mucosal immunity in the nasal compartment, which is the first barrier that the SARS-CoV-2 virus breaches before reaching the lungs.

The ability to elicit immunity in the respiratory tract can prevent infection in individuals and prevent disease transmission, said these researchers.

In a study published by iScience on September 24, 2021, these researchers reported developing an intranasal subunit vaccine candidate that uses lyophilized spike protein and liposomal STING agonist as an adjuvant.

This vaccine induces systemic neutralizing antibodies, IgA in the lung and nasal compartments, and T-cell responses in the lung of mice.

Single-cell RNA sequencing confirmed the coordinated activation of T/B-cell responses in a germinal center-like manner within the nasal-associated lymphoid tissues, confirming its role as an inductive site to enable durable immunity.

“Mucosal vaccination can stimulate both systemic and mucosal immunity and has the advantage of being a non-invasive procedure suitable for immunization of large populations,” said Varadarajan.

“However, mucosal vaccination has been hampered by the lack of efficient delivery of the antigen and the need for appropriate adjuvants that can stimulate a robust immune response without toxicity.”

As we have shown, each of our components, the protein (lyophilized) and the adjuvant (NanoSTING) are stable for over 11 months and can be stored and shipped without the need for freezing,” said Varadarajan.

Varadarajan is co-founder of AuraVax Therapeutics Inc., a pioneering biotech company developing novel intranasal vaccines and therapies to help patients defeat debilitating diseases, including COVID-19.

The company has an exclusive license agreement with UH with respect to the intellectual property covering intranasal vaccines and STING agonist technologies. They have initiated the manufacturing process and plan to engage the U.S. FDA later in 2021.

Sep 20, 2021 • 4:56 pm CDT

According to new research from the Stanford University School of Medicine published on September 17, 2021, allergic reactions to mRNA-based COVID-19 vaccines are rare, typically mild, and treatable.

In this case series of 22 patients published by the JAMA Network with suspected vaccine allergy receiving clinical skin prick testing (SPT) and basophil activation testing (BAT) to the whole vaccine and key components (i.e., polyethylene glycol [PEG] and polysorbate 80), none exhibited immunoglobulin E–mediated allergy to components via SPT.

However, most had positive BAT results to PEG, and all had positive BAT results to their administered mRNA vaccine, with no patient sample having detectable PEG IgE.

In this study, women and those with a previous history of allergic reactions appeared to have a higher risk of developing mRNA vaccine allergy.

SPT and BAT results to whole vaccine and PEG suggest a non–IgE-mediated immune response to PEG may be responsible.

“It’s nice to know these reactions are manageable,” stated Kari Nadeau, MD.., Ph.D., who directs the Sean N. Parker Center for Allergy and Asthma Research at Stanford.

“Having an allergic reaction to these new vaccines is uncommon, and if it does happen, there’s a way to manage it.” 

In the future, these Stanford researchers say testing at baseline and longitudinal measurement of IgG PEG, BATs, and other molecules will be important to test mechanisms further.

If confirmed by more systematic future investigations, these findings highlight potential opportunities for patient risk stratification and alternatives in vaccine manufacturing. Furthermore, they can inform ongoing mRNA vaccine development, including possible COVID-19 booster shots to protect against emerging disease variants.

This study was supported by grants from the Asthma and Allergic Diseases Cooperative Research Centers, the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, and the Crown and the Sunshine Foundation. In addition, researcher industry relationships were disclosed.

Sep 20, 2021 • 12:28 pm CDT

Nova Scotia-based Appili Therapeutics Inc. announced today it entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”), which will provide $1 million in funding for its Phase 3 PRESECO clinical trial of the broad-spectrum oral antiviral Avigan® / Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19.

PRESECO is investigating the safety and efficacy of Avigan / Reeqonus in the early treatment of adults infected with COVID-19.

The enrollment targets for PRESECO and the viral shedding sub-study were recently increased to include COVID-19 variant cases.

Avigan / Reeqonus is a selective inhibitor of viral RNA-dependent RNA polymerase with potent antiviral activity against single-stranded RNA viruses, including human coronaviruses.

Avigan (favipiravir) was developed initially by FFTC and approved in Japan as a treatment for pandemic influenza.

Separately, Glenmark Pharmaceuticals announced on September 15, 2021, the successful completion of its prospective, open-label, multicentre, single-arm, Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India.

The time for fever resolution was four days, while the time for a clinical cure was seven days.

The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 in over 1,000 patients.

The PMS results showed no new safety signals or concerns with the use of Favipiravir. In addition, already-known side effects such as weakness, gastritis, diarrhea, vomiting, etc., were mild in nature.

Glenmark’s PMS study is the first and largest PMS (phase 4) study conducted in India on Favipiravir in mild to moderate COVID-19 patients.

Commenting on these findings, Mr. Alok Malik, Group Vice President & Head, India Formulations, stated in a press release, “... the PMS study demonstrated FabiFlu®’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID-19."

"It is a step forward both for Glenmark and the medical community, as it reinforces the oral antiviral’s multiple benefits in tackling the pandemic.”

On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for Favipiravir (FabiFlu®), making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.

Mumbai-based Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with a presence across Generics, Specialty, and OTC business with operations in over 50 countries.

Sep 20, 2021 • 6:53 am CDT

New York-based Pfizer Inc. and BioNTech SE announced today results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of the Comirnaty vaccine at ten µg administered 21 days apart.

This dosage is smaller than the 30 µg dose used for people 12 and older.

The antibody responses in the participants given ten µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.

The data summarized from this Phase 2/3 study, which is enrolling children six months to 11 years of age, was for 2,268participants who were 5 to 11 years of age. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer was 1,197.6, demonstrating a strong immune response in this cohort of children one month after the second dose.

This compares well (was non-inferior) to the GMT of 1146.5 from participants ages 16 to 25 years old, who were administered a two-dose regimen of 30 µg.

Further, the mRNA COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

"We are eager to extend the protection afforded by the (Comirnaty) vaccine to this younger population, subject to regulatory authorization...,” stated Albert Bourla, Chairman and CEO, Pfizer, in a press release.

Pfizer and BioNTech confirmed they plan to share these data with the U.S. FDA, European Medicines Agency, and other regulators as soon as possible.

Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and six months to 2 years of age – are expected as soon as the fourth quarter of 2021.

Pfizer and BioNTech plan to submit data from the entire Phase 3 trial for scientific peer-reviewed publication.

Sep 19, 2021 • 4:33 pm CDT

The 2021-’22 American Academy of Pediatrics (AAP) influenza policy statement and companion technical report released on September 7, 2021, emphasize the importance of influenza vaccination during the COVID-19 pandemic, which is expected to continue during the flu season.

Influenza vaccines are recommended for everyone six months and older with any licensed product appropriate for age and health status, according to the AAP policy. Both inactivated influenza vaccine and live attenuated influenza vaccine are options.

Influenza vaccine can be administered simultaneously with or any time before or after administration of the currently available COVID-19 vaccines says the AAP.

As of September 19, 2021, the U.S. FDA has Approved-Authorized the Comirnaty (Pfizer - BioNTech) mRNA vaccine for most people 12 years of age and older.

Because it is unknown whether the reactogenicity of COVID-19 vaccines will be increased with the coadministration of the flu vaccine, the reactogenicity profile of the vaccines should be considered.

Clinicians should consult current guidance on coadministration of the COVID-19 vaccines with influenza vaccines from the U.S. CDC's Advisory Committee on Immunization Practices.

Studies to assess the safety and immunogenicity of coadministration of COVID-19 vaccines with other vaccines are underway or in development. Children who have acute moderate or severe COVID-19 should not receive the influenza vaccine until they have recovered.

“As we continue to face another year of the COVID-19 pandemic, timely influenza vaccination of all persons six months of age and older is a priority this year,” commented Flor M. Munoz, M.D., M.Sc., FAAP, a lead author of the policy statement issued on September 7, 2021.

“This is particularly important for anyone who has medical conditions that increase the risk for complications for both influenza and COVID-19, including children.”

The AAP policy Recommendations for Prevention and Control of Influenza in Children, 2021-2022, from the Committee on Infectious Diseases, is available at https://doi.org/10.1542/peds.2021-053744, and the technical report is at https://doi.org/10.1542/peds.2021-053745.

These AAP documents will be published in the October 2021 issue of Pediatrics.

The American Academy of Pediatrics is an organization of 67,000 pediatricians committed to the optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults.​