Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Oct 23, 2021 • 4:41 pm CDT

New York-based Pfizer Inc. submitted the required Briefing Document to obtain authorization for its COVID-19 vaccine, known globally as Comirnaty, to be used with children to the U.S. Food and Drug Administration (FDA) on October 23, 2021.

The FDA and its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will evaluate the information regarding the safety and efficacy of the Pfizer-BioNTech Comirnaty vaccine for children 5 to 11 in a meeting scheduled for October 26, 2021.

Pfizer's document says 'the benefits of reducing the risk of severe COVID-19 and death generally outweighed the risks of possible side effects in that age group.'

Although the mortality rate for COVID-19 in children is substantially lower than that in adults, COVID-19 was among the top 10 leading causes of death for children in the U.S.

As of October 20, 2021, the U.S. CDC reported 542 deaths attributed to COVID-19 (comorbidity status undisclosed) in people under 18 since January 2020, when the pandemic began in the U.S.

Additionally, there have been 138 deaths related to the combination of COVID-19 and pneumonia in the 18 and under age group.

However, the CDC reports pneumonia morbidity alone (1,043) is far more prevalent in these young people.

While mRNA vaccines have significantly reduced the health impact of severe COVID-19, they are not 100% protective.

The CDC reported deaths of fully-vaccinated Breakthrough Cases reached 10,857 as of October 18, 2021.

Pfizer-BioNTech are seeking authorization of a 10-µg dose level of COVID-19 vaccine as a two-dose primary series given three weeks apart. 

The modified formulation improves vaccine stability and simplifies vaccine administration. Adults receive 30-ug dose levels.

The 10-µg dose level was selected as the optimal dose for this age group based on the favorable reactogenicity profile and robust immunogenicity results from Phase 1 dose level finding evaluation (Study C4591007).

Overall, the safety and tolerability profile of this COVID-19 vaccine, administered as a two-dose ten µg primary series given three weeks apart to approximately 1,500 children 5 to <12 years of age who had at least two months of follow-up since their second dose, reflects age-appropriate events that are consistent with a general pediatric population and the known reactogenicity profile of the Pfizer-BioNTech vaccine, says the document.

Furthermore, no myocarditis/pericarditis (heart) cases were observed during the vaccination period through approximately three months of follow-up post-Dose 2 in the 5 to <12 years of age group in the Study.

The agenda and additional VRBPAC meeting documents have been posted at this FDA weblink. And the public can digitally attend this meeting at this link.

Interested persons may present data, information, or views on issues pending before the committee, orally or in writing. In addition, the FDA established a docket (FDA-2021-N-1088) for public comment on this meeting.

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Oct 23, 2021 • 12:31 pm CDT

The Washington, DC-based Sabin Vaccine Institute announced on October 21, 2021, the Biomedical Advanced Research and Development Authority (BARDA) had exercised the third contract option, valued at $34.5 million, to advance the development of vaccines against Ebola Sudan and Marburg viruses.

This third contract option will enable continued nonclinical efficacy and safety studies, Phase 2 clinical trials in Africa, and vaccine manufacturing processes to ensure quality and safety.

In September 2019, BARDA awarded Sabin a development contract valued at up to $128 million and had already provided funding of $40.5 million.

The need for effective Marburg vaccines is increasing.

Like Ebola Zaire, Ebola Sudan and Marburg are among the world's deadliest viruses, causing hemorrhagic fever with subsequent death in an average of 50% of cases.

Marburg virus was first recognized in 1967, when hemorrhagic fever outbreaks coincided in laboratories in Marburg and Frankfurt, Germany, and in Serbia, says the U.S. CDC.

"We are grateful for BARDA's continued support of Sabin's efforts to advance vaccines against these deadly viruses," commented Sabin CEO Amy Finan in a press release.

"We also thank our partners at the Vaccine Research Center of the NIH National Institute of Allergy and Infectious Diseases for their continued collaboration and GSK for their earlier work on the candidates." 

The two candidate vaccines, based on GSK's proprietary ChAd3 platform, were licensed to the Sabin Vaccine Institute from GSK in 2019.

Recently, a case of Marburg disease was confirmed in the West African country of Guinea, where the Ministry of Health officially declared an outbreak of Marburg on August 9, 2021. 

Only one fatal case, in which the index patient was diagnosed with the virus posthumously, was recorded, and more than 170 high-risk contacts were monitored for 21 days.

This recent case, as well as Marburg's history of outbreaks and their potential for future devastating episodes, demonstrates that preventative measures are overdue to protect civilian populations, military personnel, first responders, health care workers, and laboratory workers, both in the U.S. and abroad.

Ebola Sudan and Marburg viruses are closely related to the Ebola Zaire virus, which has caused more than 2,200 deaths since 2018.

A batch of new Ebola Zaire-related deaths has recently been confirmed in the Democratic Republic of Congo, where U.S. FDA Approved Ebola vaccines are deployed.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

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Oct 23, 2021 • 9:32 am CDT

Maryland-based Emergent BioSolutions Inc. announced on October 15, 2021, the first participant was dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the company's investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP.

CHIKV VLP is the only single-dose, VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.

The goal of this multi-center, randomized, double-blind, placebo-controlled study with 3,150 participants in up to 49 U.S. sites is to evaluate the safety and immunogenicity of the CHIKV VLP vaccine candidate in healthy individuals aged 12 to 64 as well as to demonstrate the consistency of the CHIKV serum neutralizing (SNA) antibody response across three manufactured vaccine candidate lots.

The study will observe the CHIKV SNA response at day 22, as measured by geometric mean titer and seroresponse rate.

Chikungunya virus symptoms, which are spread by infected mosquitoes, include fever, joint pain, headache, muscle pain, joint swelling, or rash, with some symptoms lasting months and years, says the U.S. CDC.

The geographic distribution of CHIKV has expanded to more than 100 countries and territories worldwide.

As of October 19, 2021, the CDC reported 16 chikungunya cases in travelers returning to the U.S. from an affected area.

"Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine candidate," stated Karen L. Smith, M.D., Ph.D., EVP, and chief medical officer at Emergent BioSolutions, in a press release.

"I am proud of the Emergent team for bringing us a step closer to potentially having a critical solution to address this important disease for which no vaccine or treatment is currently available."

Emergent's CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the U.S. FDA in October 2020 and May 2018, respectively, and PRIME designation from the European Medicines Agency in September 2019.

These designations facilitate the development or expedite review of medicines that target an unmet medical need or demonstrate substantial improvement over available therapy.

Emergent BioSolutions is a global life sciences company located in Gaithersburg, MD, whose mission is to protect and enhance life. Through our specialty products and contract development, and manufacturing services, we are dedicated to providing solutions that address public health threats.

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Oct 23, 2021 • 8:31 am CDT

Researchers with Kings College of London, UK, published a peer-reviewed study in the journal Cancer Cell on October 12, 2021, that found more than half of double vCOVID-19 vaccinated blood cancer patients have been left with little protection against the disease.

The data highlight the continued vulnerabilities of blood cancer patients to COVID-19. 

Data from the SOAP-02 clinical trial examined the level of immune protection following the delayed Pfizer - BioNTech Comirnaty vaccine boost in 128 cancer patients.

Although administering the second dose increased seroconversion rates (development of antibodies to the SARS-CoV-2 coronavirus) in blood cancer patients from less than 20% following a single dose to 57% of double-vaccinated patients, blood cancer patients still failed to mount an adequate immune response.

Furthermore, solid cancer patients, such as those with breast, urological or skin cancers, also showed poor responses to single-dose vaccination, with just 38% seroconversion rates.

However, unlike their blood cancer counterparts, these patients showed strong reactions to a second vaccine dose given at either three weeks or 12 weeks. 

In the absence of protection typically offered by vaccination, the study authors argue the urgency of the booster program, particularly at a time of very high transmissions variants in the U.K.

Professor Charles Swanton, the chief clinician at Cancer Research U.K.K., said in a press release" "This study shows that over half of blood cancer patients are unable to mount an antibody response to SARS-CoV-2 despite being vaccinated twice, which we know is an important step in preventing severe infections."

"These results add to a growing body of evidence confirming the vulnerability of patients with blood cancers during the COVID pandemic despite being vaccinated."

"As the world begins to return to normal, we must not forget vulnerable patients like this, who will need additional approaches to reduce the risk of severe disease."

This study has also highlighted several aspects of human immunology which are possibly germane to preparedness for future pandemics.

First, the frequencies of functional (cytokine-releasing) T cell responses exceeded seroconversion rates for cancer patients who received the delayed second vaccination.

This might reflect some degree of vaccine boosting of pre-existing memory T cells induced by seasonal coronaviruses, particularly those reactive to S2 antigens. However, the protective utility of these against SARS-CoV-2 is not straightforward.

Finally, it is noteworthy that vaccine non-responsiveness in patients with cancer does not reflect broad immunodeficiencies since extremely robust recall responses were made to CEFT peptides. Instead, their responsiveness to neo-antigens seems to be particularly impaired.

Note: The study authors declared no competing interests.

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Oct 22, 2021 • 10:11 am CDT

The UK Health Security Agency confirmed today the Delta variant sub-lineage (Delta AY.4.2) was designated a Variant Under Investigation (VUI) on October 20, 2021, and has been given the official name VUI-21OCT-01.

The designation was made on the basis that this sub-lineage has become increasingly common in the UK in recent months, and there is some early evidence that it may have an increased growth rate in the UK compared to the original SARS-CoV-2 coronavirus Delta variant.

The genome of VUI-21OCT-01 does not have many mutations compared to Delta.

In the last week, VUI-21OCT-01 accounted for approximately 6% of all Delta cases in all nine regions of England.

Dr. Jenny Harries, Chief Executive of the UK Health Security Agency, said in a press statement, "Viruses often mutate and at random, and it is not unexpected that new variants will continue to arise as the pandemic goes on. However, it should serve as objective evidence that this pandemic is not over."

While the evidence is still emerging, it does not appear this variant causes more severe disease or renders the vaccines currently deployed any less effective, says the Agency.

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Oct 21, 2021 • 9:29 am CDT

New Jersey-based Merck announced on October 20, 2021, the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older and for adults ages 19 to 64 with certain underlying medical conditions or other disease risk factors.

Miwako Kobayashi, M.D., MPH, presented 'Considerations for Age-Based and Risk-Based Use of PCV15 and PCV20 among U.S. Adults and Proposed Policy Options' during the ACIP Meeting on October 20, 2021.

In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX23 or with a single dose of 20-valent pneumococcal conjugate vaccine.

These updates would apply to adults who have not previously received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown.

These provisional recommendations will be reviewed by the 19th Director of the CDC, Rochelle P. Walensky, M.D., MPH, and the Department of Health and Human Services. The final recommendations will become official when published in the CDC's Morbidity and Mortality Weekly Report.

Additionally, Katherine A. Poehling, M.D., MPH. Pneumococcal Vaccines Work Group Chair ACIP presented the Pneumococcal Vaccines overview on October 20, 2021.

"Today's (ACIP) vote reinforces the potential for VAXNEUVANCE in series with PNEUMOVAX 23 to help address a significant unmet need in the U.S. for adult populations at increased risk of invasive pneumococcal disease (IPD)," stated Dr. Roy Baynes, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release.

"We look forward to the CDC's final, published recommendations and applaud the ACIP and the CDC for their continued efforts to address the significant burden of IPD by continuously evaluating vaccination recommendations utilizing a comprehensive body of scientific evidence."

  • VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. VAXNEUVANCE is contraindicated for individuals with a history of severe allergic reaction to any component of VAXNEUVANCE or diphtheria toxoid.
  • PNEUMOVAX 23 is indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F), in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. PNEUMOVAX 23 is contraindicated in individuals with a history of a hypersensitivity reaction to any component of PNEUMOVAX 23.

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. 

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Oct 21, 2021 • 9:03 am CDT

Norway-based Ultimovacs ASA announced today its universal cancer vaccine, UV1, in combination with checkpoint inhibitors, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in treating unresectable or metastatic melanoma, either as an add-on therapy to pembrolizumab or as add-on therapy to ipilimumab.

Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.

Drugs with FDA Fast Track designation may also be considered for Accelerated Approval and Priority Review, provided certain criteria are met.

Carlos de Sousa, CEO of Ultimovacs, stated in a press release, "The FDA's decision recognizes the potential synergy of UV1 and checkpoint inhibitors and will greatly encourage physicians and patients involved in our Phase II clinical trial INITIUM."

"We remain committed to progressing UV1 in our four ongoing Phase II clinical studies and assessing the development of UV1 with pembrolizumab in advanced melanoma."

The Fast Track designation is based on data from two separate Phase I trials of UV1 in combination with checkpoint inhibitors, either with pembrolizumab (anti-PD-1) or with ipilimumab (anti-CTLA-4).

Ultimovacs's UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. It is currently being investigated in combination with checkpoint inhibitors in four Phase II trials: unresectable or metastatic melanoma, ovarian cancer, head, and neck squamous cell carcinoma, and malignant pleural mesothelioma.

Ultimovacs (OSE ULTI) is developing immune-stimulatory vaccines to treat a broad range of cancers. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. 

Ultimovacs is headquartered at the Oslo Cancer Cluster Innovation Park in Oslo, Norway, and also has an office in Uppsala, Sweden.

Oct 21, 2021 • 7:46 am CDT

GlaxoSmithKline plc announced on October 20, 2021, that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Shingrix vaccine for the prevention of shingles and its complications in adults 19 years of age and older who are or will be immunodeficient or immunosuppressed due to disease or therapy.

Today's ACIP vote means that millions of adults at increased risk of shingles due to immunodeficiency or immunosuppression are now recommended to receive Shingrix.

Shingrix is intended to be administered in two doses, 2 to 6 months apart, for immunocompetent adults.

However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.

"Today's recommendation is an important clinical advancement in providing protection from shingles and its complications to adults with immunodeficiency or immunosuppression," stated Sabine Luik, Chief Medical Officer & SVP Global Medical Regulatory & Quality, GSK, in a related press statement. 

"The ACIP's vote helps to address an existing unmet need as individuals who are immunocompromised are at an increased risk of the disease."

This approval and recommendation for a new population were based on clinical studies examining the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone an autologous hematopoietic stem cell transplant and those undergoing treatment for hematological malignancies.

In addition, other safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.

Shingrix combines a non-live antigen to trigger a targeted immune response with a specifically designed adjuvant system to generate a Varicella Zoster Virus (VZV)-specific immune response. Shingrix is not indicated for the prevention of primary varicella infection (chickenpox).

GSK is a science-led global healthcare company based in London and Philadelphia with a special purpose: to help people do more, feel better, live longer.

Oct 20, 2021 • 8:07 pm CDT

The U.S. Food and Drug Administration (FDA) issued a press statement on October 20, 2021, which included confirmation of 'ongoing analyses from the FDA and the US Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions related to the Moderna (SpikeVax) COVID-19 vaccine.'

Both myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported following vaccination with SpikeVax, particularly following the second dose.

Typically, the onset of heart inflammatory symptoms has been a few days following SpikeVax vaccination, says the FDA.

Furthermore, the FDA confirmed the observed heart risk is higher among men under 40 years of age, particularly younger men 18 through 24.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, stated: “We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”

Earlier, Tom Shimabukuro, M.D., MPH, MBA, with the CDC's Vaccine Safety Team, presented the COVID-19 Vaccine Safety Update on June 23, 2021. The analysis of preliminary reports of myocarditis/pericarditis is in progress. And limited outcome data suggest most patients (at least 81%) had complete recovery of symptoms.

Then on September 8, 2021, the CDC and its partners confirmed they were 'actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. Active monitoring includes reviewing data and medical records and evaluating the relationship to COVID-19 vaccination.'

And recently, Nordic countries released data on the increased incidence of myocarditis and pericarditis after vaccination with Moderna's vaccine in early October 2021.

These heart issues appear to be related to mRNA vaccines given as the first dose, reported Norway. And in Sweden, the use of Moderna's SpikeVax vaccine was restricted to individuals born before 1991.

Then the Wall Street Journal reported on October 16, 2021, the U.S. FDA confirmed it is reviewing Moderna's SpikeVax COVID-19 vaccine's risk of generating inflammatory heart conditions in young men.

"I think people can be reassured that the risk of myocarditis (from) an mRNA vaccine is low, it appears to be balanced between the different products," Moderna Chief Medical Officer Paul Burton told WSJ.

The FDA's updated disclosures say, 'you should seek medical attention right away if you have any of the following symptoms after receiving the Moderna COVID-19 Vaccine: Chest pain, Shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart.'

And report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967.

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Oct 20, 2021 • 6:12 pm CDT
US FDA

The U.S. Food and Drug Administration (FDA) took action today, expanding the use of a booster dose for COVID-19 vaccines in eligible populations.

This FDA action follows presentations of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines, and Related Biological Products Advisory Committee discussion of information submitted for consideration, along with the agency's evaluation of the available data.

The FDA determined that the known and potential benefits of using a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.

The FDA is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow a heterologous (or "mix and match") booster dose for eligible individuals following completion of primary vaccination with a different COVID-19 vaccine.

  • Specifically, the use of a single booster dose of the Moderna (SpikeVax) COVID-19 Vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to the SARS-CoV-2 betacoronavirus.
  • Additionally, the use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
  • Furthermore, to clarify that a single booster dose of the Pfizer-BioNTech (Comirnaty) COVID-19 Vaccine may be administered at least six months after completing the primary 2-dose series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

The agency encourages health care providers to follow the recommendations that the U.S. CDC will provide following a meeting of the Advisory Committee on Immunization Practices on October 21, 2021, and formal recommendations signed by the CDC's director Rochelle P. Walensky, M.D., MPH.

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. 

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Oct 20, 2021 • 12:16 pm CDT

During today's U.S. CDC's Advisory Committee on Immunization Practices (ACIP) meeting, Ruvim Izikson, M.D., MPH, presented 'Phase II safety and immunogenicity study of the coadministration of an influenza vaccine and high-dose flu shot.'

This study is essential since the new COVID-19 vaccine primary series timing and strategy, and older adults are most likely eligible for COVID-19 boosters and their annual influenza vaccine during the same window of time.

This scheduling conflict creates the risk that many seniors get vaccinated only for one or the other; with the priority on the 3rd dose of COVID-19 vaccine, the annual flu shot is more likely the missed vaccination.

This study's results are based on Sanofi Pasteur's Fluzone® High-Dose Quadrivalent Influenza Vaccine (QIV-HD) and the third dose of SpikeVax COVID-19 vaccine (Moderna, mRNA-1273) on October 20, 2021.

This vaccine study assesses the safety and immunogenicity of Fluzone, 2021–2022 Formulation, and the third dose of SpikeVax (100µg), administered either concomitantly or singly in adults 65 yrs+, previously vaccinated with a 2-dose schedule of the SpikeVax vaccine.

The study's results demonstrate that QIV-HD and SpikeVax vaccines can be administered safely together without evidence of immunogenicity interference.

In summary, this finding supports COVID-19 and influenza vaccine coadministration recommendations.

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Oct 20, 2021 • 10:11 am CDT

The U.S. CDC's Morbidity and Mortality Weekly Report published on October 19, 2021, found among (179) hospitalized patients aged 12–18 years, the two-doses of Pfizer-BioNTech Comirnaty vaccine effectiveness against COVID-19 hospitalization during June–September 2021 was 93%.

Among the 179 COVID-19 case patients, six (3%) were vaccinated, and 173 (97%) were unvaccinated.

And, among 169 case patients with available hospital discharge data, the median length of hospital stay was five days for unvaccinated patients and three days for vaccinated patients.

Furthermore, 72% of these adolescents had at least one underlying condition, including obesity.

The findings in this report are subject to at least six limitations, including, but not limited to, the sample was too small to assess Comirnaty's vaccine effectiveness by underlying conditions or by other subgroups of interest, including against critical illness.

These findings of this limited study reinforce the importance of vaccination to protect U.S. youths against severe COVID-19, says the CDC.

As of October 18, 2021, 46% of U.S. children and adolescents aged 12–15 years and 54% of 16–17 years were fully vaccinated against COVID-19. This data compares with all authorized persons being 57% being fully vaccinated.

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Oct 20, 2021 • 9:17 am CDT

In response to media reporting citing anonymous sources, Maryland-based Novavax, Inc. issued a press statement on October 20, 2021, 'confirming our confidence in our ability to deliver our high-quality vaccine.'

Furthermore, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.

Since March 2020, Novavax has worked diligently, methodically, and transparently to develop our novel COVID-19 vaccine candidate (NVX-CoV2373), taking on the challenge of developing and producing at large scale a proven biologic-based vaccine amid unprecedented circumstances.

We have made significant progress in mobilizing a global manufacturing network over the past 18 months with sites that are now routinely producing high-quality products at commercial scale across the world.

Our global supply chain is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter through:

  • Partnership with the Serum Institute of India (SII), the world's largest vaccine manufacturer,
  • A state-of-the-art, wholly-owned manufacturing site in the Czech Republic,
  • Manufacturing at established vaccine makers, including SK bioscience in South Korea and Takeda in Japan.

Moreover, 'we expect to complete multiple ongoing rolling regulatory submissions within the next couple of weeks in key markets, including the United Kingdom, Europe, Canada, Australia, and New Zealand.

The Company, along with SII, has already filed for authorization in India, Indonesia, and The Philippines and Emergency Use Listing with the World Health Organization.

The WHO EUL will allow Novavax and SII to deliver on our combined commitment to the COVAX Facility for a cumulative 1.1 billion doses of our vaccine, around which we maintain ongoing conversations with CEPI, Gavi, and UNICEF.

Additionally, we expect to file for Emergency Use Authorization in the U.S. before the end of 2021.

"We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world's ability to end the pandemic: global distribution challenges and vaccine hesitancy," said Stanley C. Erck, President & CEO, Novavax, in the press statement.

Novavax's COVID-19 protein-based vaccine Phase 3 study data show a robust safety profile, strong immunogenicity, and high efficacy against multiple strains of the coronavirus. 

Previously, Novavax published an update regarding its COVID-NanoFlu™ combination vaccine candidate. The Company's NanoFlu™ and NVX-CoV2373 both have demonstrated strong results as standalone vaccines in Phase 3 clinical trials. 

Novavax, Inc. (NVAX) is a biotechnology company located in Gaithersburg, MD that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.

Oct 20, 2021 • 7:59 am CDT

The Washington-based Bill & Melinda Gates Foundation announced on October 19, 2021, a commitment of up to $120 million to accelerate access to the investigational antiviral drug molnupiravir as part of its COVID-19 response effort.

The goal is to significantly reduce the time for a new drug to reach low-income countries after it becomes available in high-income markets. The standard gap in rolling out global health products can be 12 months or more.

The new Gates funding will be allocated based on consultations with partners.

It will support the range of activities required to develop and manufacture generic versions of the molnupiravir, which is being developed by Merck & Co and Florida-based Ridgeback Biotherapeutics.

Molnupiravir is an experimental oral antiviral initially developed by Emory University to treat influenza. 

Molnupiravir is an orally bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including the SARS-CoV-2 betacoronavirus, the causative agent of COVID-19.

On October 1, 2021, Merck confirmed plans to seek U.S. FDA Emergency Use Authorization.

If Authorized, Molnupiravir could be the first oral antiviral medicine for COVID-19 in the U.S.

"Africa CDC and the Africa Union have been tracking the exciting developments on the antiviral, molnupiravir," said John Nkengasong, director of the Africa Centers for Disease Control and Prevention, stated in a press release. 

"In order to make sure that Africa is not left behind, we have been working with the Bill & Melinda Gates Foundation colleagues on various mechanisms they can facilitate, once all of the regulatory processes are completed, and the drug (Molnupiravir) is officially made available to the world."

The Gates Foundation's previous work to lower costs and increase access to life-saving drugs includes dolutegravir, an HIV drug.

In 2017, the Foundation established a volume guarantee with two generic suppliers that brought therapies containing the drug to more than 18 million people in lower-income countries, in coordination with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

The Foundation has already provided expertise and funding to help strengthen generics manufacturers, including $1.3 million to Medicines for All Institute and the University of Manchester to develop low-cost manufacturing processes that dramatically reduce the cost of raw materials and increase product yields.

Additionally, the Foundation has provided $2.4 million in grants to expedite generic company readiness to apply for WHO prequalification and start manufacturing when prequalification is granted.

"Merck has taken important steps to make this drug available as a COVID-19 therapy, including negotiating licenses with generics manufacturers to increase supply. We are pleased to work alongside these efforts to ensure affordability and availability in lower-income countries," commented Bill Gates, co-chair of the Gates Foundation.

"Making life-saving drugs like these available to everyone who needs them is what is necessary to end the acute phase of the pandemic and open pathways to recovery."

Since the start of the COVID-19 pandemic, the Foundation has worked closely with a range of partners on R&D and delivery of COVID-19 tools. The Foundation will continue to work with multilateral organizations, non-governmental organizations, governments, and other partners to ensure that clinical, regulatory, and delivery pathways are ready once molnupiravir and its generic versions become available.

About the Bill & Melinda Gates Foundation: Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives.

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Oct 19, 2021 • 7:01 pm CDT

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) meeting for October 20, 2021, has posted its draft agenda. The CDC has established this webcast link for those who want to attend the open session.

The ACIP intends to review the pneumococcal vaccines. Dr. Katherine Poehling will lead the presentation on considerations for age-based and risk-based use of PCV15/PCV20 among adults and proposed policy options.

Then, the ACIP will focus on zoster vaccines. Dr. Camille Kotton will lead the interpretation of the EtR regarding the use of RZV in immunocompromised adults, considerations for use, and proposed policy options.

In the afternoon, Dr. Keipp Talbot will lead a discussion on Fluzone® High-Dose Quadrivalent Influenza Vaccine and a third dose of Moderna's SpikeVax mRNA-1273 COVID-19 vaccine.

Additionally, the committee will discuss an expanded age indication for Flucelvax Quadrivalent.

Before adjourning for the day, the ACIP may vote on the proposed recommendations.

Once the recommendations are reviewed by the CDC Director and Department of Health and Human Services, the recommendations, if approved, are published in the CDC's MMWR.

Rochelle P. Walensky, MD, MPH, is the 19th Director of the Centers for Disease Control and Prevention.

The new ACIP Chair is Grace M. Lee, MD, MPH, Associate Chief Medical Officer for Practice Innovation, Lucile Packard Children's Hospital, Professor of Pediatrics, Stanford University School of Medicine.

In addition to the 15 voting members, the ACIP includes eight ex officio members who represent other federal agencies responsible for immunization programs in the United States and 30 non-voting representatives of liaison organizations that bring related immunization expertise.