Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jun 20, 2021 • 9:41 am CDT

As of June 9, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) had received 885 Yellow Card reports of suspected adverse drug reactions to the Vaxzevria COVID-19 vaccine, in which the patient died shortly after vaccination.

Additionally, the MHRA confirmed 34 reports of myocarditis and 61 reports of pericarditis following the use of the vaccine. And 740 spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions.

Furthermore, 390 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) have been reported following vaccination with COVID-19 Vaccine AstraZeneca.

The nature and frequency of these reports are in line with that reported in previous updates, says the MHRA, the Executive Agency of the UK Department of Health and Social Care.

On December 30, 2020, the MHRA provided authorization for an emergency supply of COVID-19 Vaccine AstraZeneca for the active immunization of individuals 18 years or older. Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, says the European Medicine Agency.

As of June 20, 2021, Vaxzevria has not been authorized for use in the USA by the U.S. FDA.

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Jun 18, 2021 • 5:47 pm CDT

IAVI announced on June 15, 2021, it received an award of ~US$27 million from the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a Phase IIb clinical trial of a novel vaccine candidate to prevent Lassa fever disease.

An acute viral illness endemic to many parts of West Africa, Lassa fever causes significant annual outbreaks of disease. Lassa fever is endemic in West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria, says the U.S. CDC.

As a result, there are an estimated 5,000 related deaths each year. Despite this disease burden, which is believed to be significantly underestimated, no vaccine for Lassa fever is currently available, says IAVI.

IAVI’s Lassa fever vaccine candidate, rVSV∆G-LASV-GPC, uses a recombinant vesicular stomatitis virus (rVSV) vector — the same rVSV platform used for Merck's rVSV-vectored Ebola Zaire vaccine, ERVEBO®, which is now registered for use in eight African countries.

rVSV∆G-LASV-GPC provided high-level protection from Lassa fever in previously conducted animal studies. A phase 1 study is evaluating the Safety and Immunogenicity of the rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health.

IAVI, EDCTP, and CEPI are united in their commitment to global equitable access to vaccines, with rVSV∆G-LASV-GPC to be accessible to all populations that need the candidate vaccine, should it be found safe and effective in clinical testing.

Jun 18, 2021 • 10:52 am CDT

The U.S. CDC published the 2020-2021 Influenza Season Report for Week #23, which indicates the flu season in the USA is coming to a close. 

Based on mortality surveillance data available on June 17, 2021, about 7.6% of the deaths that occurred during week #23 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 1,360 PIC deaths reported last week, 601 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and zero listed influenza.

Furthermore, the CDC re-confirmed only (1) influenza-associated pediatric death has occurred during the 2020-2021 flu season in the USA.

During the 2019-2020 flu season, the CDC confirmed (199) influenza-associated pediatric deaths.

The CDC data presented are preliminary and may change as more data are received and processed.

For the past several years, the CDC has estimated the burden of influenza and the impact of annual influenza vaccination in the USA. 

Influenza vaccination prevented an estimated 7.52 million illnesses, 3.69 million medical visits, 105,000 hospitalizations, and 6,300 deaths due to influenza during the 2019-2020 season. In addition, flu vaccination prevented the greatest proportion of outcomes among children aged 6 months to 4 years, an age group in which there was high vaccine uptake, and the vaccine effectiveness was greatest, says the CDC.

An updated list of influenza vaccines for the 2021-2020 flu season is published on this webpage.

Jun 18, 2021 • 10:27 am CDT

The World Health Organization (WHO) released on June 17, 2021, an updated global list of high burden countries for tuberculosis (TB), HIV-associated TB, and multidrug/rifampicin-resistant TB on June 17, 2021. The WHO's new lists are for 2021–2025.

The main changes compared with the previous lists for 2016-2020 are as follows:

  • The 30 high TB burden countries: Cambodia, the Russian Federation, and Zimbabwe, have transitioned out of the list; while Gabon, Mongolia, and Uganda have joined the list.
  • The 30 high TB/HIV burden countries: Angola, Chad, Ghana, and Papua New Guinea have transitioned out of the list; and Gabon, Guinea, the Philippines, and the Russian Federation have joined the list.
  • The 30 high MDR/RR-TB burden countries. Ethiopia, Kenya, and Thailand have transitioned out of the list; moreover, Mongolia, Nepal, and Zambia have joined the list.

The context of the COVID-19 pandemic was considered before finalize the updated global high-burden country lists. Based on this analysis, it was concluded that it was unlikely that the COVID-19 pandemic would change the countries included in each list, stated the WHO.

Tuberculosis is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain, says the U.S. CDC.

In November 2019, the WHO removed a freeze-dried BCG vaccine (GreenSignal Bio Pharma Pvt Ltd., India.) to prevent tuberculosis from its list of prequalified vaccines for procurement by UN agencies.

Alternative sources of prequalified BCG vaccines are available, such as Merck's TICE BCG vaccine.

BCG should be considered for very select people who meet specific criteria and in consultation with a TB expert in the USA. In addition, health care providers who are considering BCG vaccination for their patients are encouraged to discuss this intervention with the TB control program in their area, says the CDC.

Jun 18, 2021 • 9:02 am CDT

Germany-based BioNTech SE announced the first patient had been treated in its BNT111 Phase 2 cancer vaccine trial. The study evaluates the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III-IV melanoma.

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer. 

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as an RNA-lipoplex formulation.

The BNT111-01 trial, which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy, Poland, and the United Kingdom, the USA, Australia.

“Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget that cancer is also a global health threat, even worse than the current pandemic,“ said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a press release.

Mainz, DE-based Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.  BioNTech’s fully-owned mRNA cancer vaccine platform is separate from the Pfizer-BioNTech COVID-19 vaccine program.

Jun 17, 2021 • 9:17 pm CDT

Canada's National Advisory Committee on Immunization (NACI) confirmed on June 17, 2021, it is continuing to recommend that COVID-19 vaccines and non-COVID-19 vaccines should not be routinely given at the same time.

If possible, COVID-19 vaccines should be given at least 14 days after and 28 days before other vaccines, with some exceptions.

This schedule will help people avoid possible overlapping side effects and potential (but unknown) interference with the immune response between vaccines, says the NACI statement.

However, there may be circumstances when a dose of a COVID-19 vaccine and a non-COVID-19 vaccine need to be administered simultaneously or when a non-COVID-19 vaccine needs to be administered within 28 days after a COVID-19 vaccine.

A healthcare professional can help make this assessment and discuss the benefits and possible risks with each individual, says NACI.

Jun 17, 2021 • 5:29 pm CDT

The Journal of the American Academy of Pediatrics (AAP) published a new study indicating a significant decrease in measles vaccinations during the COVID-19 pandemic.

On June 17, 2021, the AAP revealed vaccine uptake and vaccination coverage for measles-containing vaccines decreased compared with the corresponding months in 2019. Total and measles-containing vaccine administration declined (-25.2% for those under 2), (-83.0% for those 2 to 6), and (-87.6% for those 13 to 18).

However, complete vaccination coverage changed minimally at ages 7 and 13 years, it declined gradually at age 17 years.

This observational, retrospective, open cohort study was conducted at Kaiser Permanente Southern California, an integrated health care system providing prepaid services for 4.6 million members whose socio-demographics mirror the diverse Southern California population.

This is very important to public health because high levels of population immunity are required to prevent outbreaks of many vaccine-preventable diseases (VPDs), says the AAP. Therefore, continued efforts to increase recommended vaccine uptake and ongoing monitoring of their impact on vaccination coverage in all pediatric age cohorts for possible improvements will be essential to preventing future outbreaks of VPDs.

The M-M-R II vaccine is indicated for simultaneous vaccination against measles, mumps, and rubella in the USA. This vaccine is usually given to children 1-year of age or older.

Jun 17, 2021 • 4:55 pm CDT

The U.S. CDC announced late on June 17, 2021, the emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on June 18th has been rescheduled due to observing the Juneteenth National Independence Day holiday.

The ACIP discussions on the proposed agenda will be included in the regularly scheduled ACIP meeting on June 23-25, 2021.

The previous agenda included an update on COVID-19 vaccine safety, including myocarditis after mRNA vaccines assessment. 

As of June 9, 2021, the CDC and U.S. FDA have confirmed 268 reports of myocarditis or pericarditis among people ages 30 and younger who received a COVID-19 vaccine. Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in males.

Furthermore, the ACIP intended to lead a benefit-risk discussion of COVID-19 mRNA vaccines in adolescents and young adults.

The June 23rd ACIP meeting will be held virtually without requiring registration to attend.

Jun 17, 2021 • 3:59 pm CDT

The U.S. Food and Drug Administration (FDA) approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch on June 17, 2021.

The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older. 

Azelastine can cause drowsiness. The label warns that consumers using this product should avoid alcoholic drinks and be careful when driving a motor vehicle or operating machinery. Using azelastine nasal spray with alcohol, sedatives, or tranquilizers may increase drowsiness, says the FDA.

“Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing, and more,” commented Theresa M. Michele, M.D., director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement.

“Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.”

For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

This approval is a first-in-class switch for a nasal antihistamine. It is considered a partial switch because of the 0.1% strength, which includes the perennial allergy indication for children 6 months to 6 years old and seasonal allergy indication for children 2 to 6 years old, which will remain prescription based.

The FDA granted the approval of nonprescription Astepro to Bayer Healthcare LLC.

Jun 17, 2021 • 9:12 am CDT

Sanofi announced the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research had granted approval to Sanofi Pasteur for an additional influenza manufacturing facility located in Swiftwater, PA.

The newly completed facility further expands production and distribution of Sanofi's Fluzone® High-Dose Quadrivalent for the upcoming 2021-2022 influenza season in the USA.

"We are experiencing fast-growing demand for our vaccine in the U.S. and globally, given the 10 years of data demonstrating protection from flu and its related complications," said Elaine O'Hara, Head of North America Commercial Operations for Sanofi Pasteur, in a press statement.

"Our new facility will complement our existing capacities to produce enough high-dose vaccine for all people 65 and older in as many countries as possible this flu season and beyond, supporting the needs of healthcare providers and patients."

Fluzone Quadrivalent contains the 2 strains of influenza A and B identified for the current flu season. The vaccine is given to people 6 months of age and older. And Fluzone High-Dose is a vaccine given to people 65 years of age and older that also contains 4 killed flu virus strains.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Jun 17, 2021 • 6:57 am CDT

Germany-based CureVac N.V. announced results of the second interim analysis of its HERALD pivotal Phase 2b/3 study in approximatively 40,000 subjects of the first-generation COVID-19 vaccine candidate, CVnCoV.

In the unprecedented context of at least 13 SARS-CoV-2 coronavirus variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria.

The interim results suggest vaccine efficacy in younger participants but did not allow to conclude on efficacy in those above 60.

The HERALD's initial analyses included 134 COVID-19 cases and suggested age and strain-dependent efficacy.

The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. More than half of the cases (57%) were caused by Variants of Concern.

Most of the remaining cases were caused by other less characterized variants such as Lambda or C.37 (21%) and B.1.621 (7%).

The Data Safety Monitoring Board confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis, and the totality of the data will be assessed for the most appropriate regulatory pathway.

“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change,” stated Dr. Franz-Werner Haas, CEO of CureVac, in a press release.

“In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.”

The HERALD study, conducted by Curevac in conjunction with Bayer, enrolled approximately 40,000 participants in ten countries in Latin America and Europe. To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 424 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis.

Available data were communicated with the European Medicines Agency, which began its rolling review in February 2021. CureVac remains committed to COVID-19 vaccine development, said the company.

CureVac is a global biopharmaceutical company located in Tubingen, Germany, in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases.

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Jun 16, 2021 • 1:18 pm CDT

An Australian-led study confirmed it is exploring the immune response to COVID-19-specific vaccines in Brazilian healthcare workers to find biomarkers that indicate whether someone will be protected from - or remains at risk of - contracting COVID-19 if exposed to a variant.

The research has received philanthropic funding from the Bill & Melinda Gates Foundation and is a sub-study of the Murdoch Children’s Research Institute’s (MCRI) study assessing if the Bacille Calmette-Guérin (BCG) vaccine can help protect against COVID-19.

The BRACE trial is now the world’s largest study on the off-target effects of the BCG vaccine. Since the trial launched in March 2020, more than 6,800 healthcare workers have enrolled across 36 sites in Australia, Brazil, the Netherlands, Spain, and the UK.

BCG was originally developed 100 years ago to prevent tuberculosis. Now, the BRACE randomized controlled clinical trial is working to determine if the BCG vaccine reduces the incidence of symptomatic and severe COVID-19 in healthcare workers. It is also investigating whether the BCG vaccine reduces the impact of other respiratory illnesses and allergic diseases.

Professor Nigel Curtis, Head of the Infectious Diseases Research Group at MCRI, Professor of Paediatric Infectious Diseases at the University of Melbourne, and BRACE Chief Principal Investigator, said the big story of 2021 was the potential impact of SARS-CoV-2 variants.

“With the emergence of new variants - for which vaccine-induced and natural immune responses may not be as effective - there is concern that herd immunity may be undermined. If this happens, SARS-CoV-2 will continue to spread and cause disease,” Prof. Curtis stated in a press release issued on June 8, 2021.

“We have been lucky enough to receive this additional funding for the BRACE COVID-19-Specific vaccine sub-study (BCOS) to investigate biomarkers of protection against SARS-CoV-2 infection and reinfection induced by natural infection and COVID-specific vaccination.”

With COVID-19-specific vaccines now available to healthcare workers, BCOS will also examine whether the BCG vaccine improves the immune response to Pfizer, AstraZeneca, and CoronaVac vaccines.

MCRI Dr. Nicole Messina, the Biosample and Laboratory Lead on the BRACE trial and University of Melbourne honorary, commented, “We are recruiting existing BRACE trial participants in Victoria, South Australia, and Brazil to assess whether those who had the BCG vaccine have a better or more prolonged immune response to their COVID-19-specific vaccine.”

The BRACE trial has received philanthropic funding from the Bill & Melinda Gates Foundation, Sarah and Lachlan Murdoch, Minderoo Foundation, The Royal Children’s Hospital Foundation, South Australian government, NAB Foundation, The Calvert Jones Foundation, UHG Foundation, Modara Pines Charitable Foundation, Health Services Union NSW, Peter Sowerby Foundation, South Australia Ministry of Health, Epworth Health, Swiss National Science Foundation, and individual donors.

Jun 16, 2021 • 12:59 pm CDT

Massachusetts-based Moderna, Inc. announced that the U.S. government had purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.

This purchase brings the U.S. government’s confirmed order commitment to 500 million doses, including 110 million doses expected to be delivered in the 4th quarter of 2021 and 90 million expected to be delivered in the 1st quarter of 2022.

As of June 14, 2021, Moderna has supplied 217 million released vaccine doses to the U.S. government.

Stéphane Bancel, CEO of Moderna, stated in a related press release, “We remain focused on being proactive as the virus evolves by leveraging the flexibility of our mRNA platform to stay ahead of emerging variants.”

Moderna COVID-19 Vaccine is Authorized for use under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals 18 years of age and older. The U.S. FDA has not approved Moderna's vaccine.

Jun 16, 2021 • 11:43 am CDT

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) scheduled an emergency meeting for 11 am EST on June 18, 2021. Dr. José Romero will be the chairman of this ACIP meeting's agenda that includes, but is not limited to, the following topics:

  • Update on COVID-19 vaccine safety, including myocarditis after mRNA vaccines VaST assessment. As of June 9, 2021, the CDC and U.S. FDA have confirmed 268 reports of myocarditis or pericarditis among people ages 30 and younger who received a COVID-19 vaccine. Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in males.
  • COVID-19 mRNA vaccines in adolescents and young adults: benefit-risk discussion.

The June 18th ACIP meeting will be held virtually without requiring registration to attend.

An interested person who wishes to make an oral public comment during an ACIP meeting should submit a request with the CDC before the meeting, Docket No. CDC-2021-0060, according to the instructions in the Federal Register Notice. Those who have not submitted a request before the meeting will only have an opportunity to speak as time permits or at the discretion of the Chair, Dr. Romero.

Previous ACIP meeting information is available at this link.

The ACIP offers advice and guidance to the Director of the CDC regarding the use of vaccines and related agents to control vaccine-preventable diseases in the civilian population of the USA. The CDC Director reviews recommendations made by the ACIP and, if adopted, are published in the Morbidity and Mortality Weekly Report. Previous announcements are found at this CDC link.

Jun 16, 2021 • 11:26 am CDT

The U.S. Food and Drug Administration (FDA) announced on June 15, 2021, the agency authorized the use of an additional batch of vaccine drug substance under the emergency use authorization for the J&J - Janssen COVID-19 vaccine manufactured at the Emergent facility in Maryland.

To date, a total of three batches of Janssen drug substances that were manufactured at Emergent's facility have been authorized.

This FDA action follows the June 11th authorization of certain batches of the Janssen COVID-19 vaccine drug substance produced by Emergent BioSolutions.

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