Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jun 15, 2021 • 6:54 pm CDT

A new antibody testing study announced on June 15, 2021, examining samples originally collected through the US National Institutes of Health All of Us Research Program, found evidence of SARS-CoV-2 infections in five states earlier than had initially been reported.

These researchers detected antibodies against SARS-CoV-2 using two different serology tests in nine participants’ samples. These findings were published in the journal Clinical Infectious Diseases. 

The results expand on findings from a previous Centers for Disease Control and Prevention study that suggested SARS-CoV-2, the beta coronavirus that causes COVID-19, was present in the USA as far back as December 2019.

Jun 15, 2021 • 8:24 am CDT

A biopharmaceutical company based in Pennsylvania focused on developing a vaccine to save lives from COVID-19 announced that it had selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for the Covaxin™ vaccine to prepare for potential commercial manufacturing for the US and Canadian markets.

Covaxin is a highly purified and inactivated vaccine developed in collaboration with the Indian Council of Medical Research and Bharat Biotech manufactured using a vero cell manufacturing platform.

Covaxin is currently authorized in thirteen countries.

J.P. Gabriel, Ocugen, Inc.’s Senior Vice President, Manufacturing and Supply Chain, stated in a press release, “Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the U.S. FDA and Health Canada. Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.”

Covaxin clinical studies show potential effectiveness against three key variants of SARS-CoV-2. In addition, these studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

Ocugen, Inc. and India-based Bharat Biotech announced on February 2, 2021, a definitive agreement to commercialize Covaxin in the USA, with a later agreement expansion for the Canadian market.

Jun 15, 2021 • 4:39 am CDT

Maryland-based Novavax, Inc. announced data from the first co-administration study of a SARS-CoV-2 vaccine candidate [Novavax, NVX-CoV2373] and an approved influenza vaccine.

As part of Novavax's Phase 3 clinical trial of NVX-CoV2373 in the United Kingdom, about half of 431 volunteers also received an approved seasonal influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based, quadrivalent seasonal influenza vaccine].

The sub-study demonstrated that vaccine efficacy appeared to be preserved in those receiving both vaccines compared to those vaccinated with NVX-CoV2373 alone.

Vaccine efficacy in the sub-study was 87.5% (95% CI: -0.2, 98.4), while efficacy in the main study was 89.8% (95% CI: 79.7, 95.5) against SARS-CoV-2.

Local and systemic reactogenicity was largely absent or mild in all groups. A few events, such as pain and tenderness at the injection site and muscle aches, were elevated in those co-vaccinated.

Rates of severe events were low in all groups, and there were no additional early safety concerns associated with co-administration. 

"This study shows how important it is to assess the safety profile and immune responses when COVID-19 and influenza vaccines are administered at the same time," stated Professor Paul Heath, FRCPCH, Vaccine Institute, St George's, University of London, and St George's Hospital, London, who is chief investigator of the Novavax United Kingdom trial.

"The results are reassuring, and we are excited by the possibility of concomitant use of these vaccines as an important tool in the fight against both of these important respiratory viruses," said Health in the press statement issued on June 14, 2021. 

Despite the decrease in the immunogenicity with concomitant vaccination, anti-Spike antibody levels were more than 3-fold higher than levels found in the convalescent serum in those who received both vaccines.

"These data could be used to help inform guidance or recommendations on the co-administration of influenza and COVID-19 vaccines, overcoming challenges and contributing towards a new normal to protect at-risk populations from both infections," added Raja Rajaram, M.D., Medical Affairs Lead, EMEA, Seqirus, a co-author of the study.

Novavax, Inc. (NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

Jun 14, 2021 • 3:30 pm CDT

Ethiopian health officials launched an oral cholera vaccination campaign targeting 2 million people children in the Tigray region to avert a potential outbreak. Coverage with a full two-round dose of oral cholera vaccine provides up to five-year protection.

“The oral cholera vaccine is one of the proven preventive measures that can help avert needless sickness and death if done promptly,” said Dr. Boureima Hama Sambo, WHO Representative in Ethiopia, in a press statement.

The cholera vaccination drive began on June 10, 2021, is being carried out alongside measures such as the provision of water purification tablets and handwashing soaps to improve water, sanitation, and hygiene.

The Ethiopian Public Health Institute (EPHI) and the Tigray Regional Health Bureau lead the campaign, with logistical support from the Ethiopian Pharmaceutical Supply Agency and technical and operational support from World Health Organization (WHO) and partner organizations.

“In addition to the WHO’s role in the procurement and deployment of the vaccine doses, WHO teams have been working with our teams providing technical, operational, and logistical support. I commend the unreserved support and look forward to our continued partnership to ensure the health and safety of the people of Tigray, one of Ethiopia’s regions prone to seasonal cholera outbreaks,” commented Dr. Fasika Amdeselassie, head of the Tigray Health Bureau.

The Federal Democratic Republic of Ethiopia is located within the tropical latitudes and is relatively compact, with similar north-south and east-west dimensions. Ethiopia is the largest and most populated (~117 million) country in the Horn of Africa. 

Cholera is a highly contagious disease transmitted through contaminated water or food. It causes severe diarrhea and dehydration that must be treated immediately to prevent death, which can occur in just a few hours, and to prevent the disease from spreading on a large scale in a high-risk environment, says the WHO.

The U.S. FDA recently approved a single-dose live oral cholera vaccine called Vaxchora®. The CDC's Advisory Committee on Immunization Practices voted to approve the vaccine for adults 18 – 64 years old who are traveling to an area of active cholera transmission.

 

Jun 13, 2021 • 4:53 pm CDT

According to the US Centers for Disease Control and Prevention (CDC), following the 2005 WHO's resolution, Europe could soon eliminate Rubella, a disease that causes miscarriages or serious congenital disabilities in a developing baby when a pregnant woman is infected.

The CDC confirmed in an MMWR issued on June 11, 2021, the estimated coverage with the first dose of a rubella-containing vaccine (RCV1) in the European Region (EUR) was 60% in 2000. That year, 621,039 rubella cases were reported, with an incidence of 716.9 cases per 1 million population.

However, EUR's rubella coverage with the first and second doses of RCVs significantly improved over the past 10 years.

By 2019, thirty-one countries reported significant progress and achieved ≥95% RCV1 coverage. Moreover, the rubella incidence declined to 0.7 cases per 1 million population by 2019.

This vaccination progress would make EUR the second WHO region to achieve rubella elimination, the first being the Region of the Americas.

Rubella can be prevented with the MMR vaccine. This protects against three diseases: measles, mumps, and rubella.

The CDC recommends children get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.

And the CDC says the 'MMR vaccine is very safe and effective.'

In the USA, the M-M-R-II vaccine is often available at healthcare provider clinics or pharmacies.

Jun 13, 2021 • 12:18 pm CDT

Maryland-based Novavax, Inc. announced on June 11, 2021, preclinical and clinical data on the company's original recombinant protein COVID-19 vaccine candidate, NVX-CoV2373, and for a new vaccine against the SARS-CoV-2 Beta (B.1.351) variant.

The company's data shows that the vaccines demonstrated strong immunogenicity and protection against both the Alpha (B.1.1.7) variant, which was originally identified in the United Kingdom, and the Beta (B.1.351) variant and the original SARS-CoV-2 in animal and human studies.

A non-peer-reviewed preprint of the manuscript, 'Immunogenicity and In vivo protection of a variant nanoparticle vaccine that confers broad protection against emerging SARS-CoV-2 variants,' is available at bioRxiv.org.

Matthew Frieman, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, who collaborated on these studies, stated in a press release, "This work demonstrates that variant vaccines that protect against these newly emerging variants have the potential to be highly effective and may produce broader protection against variants we know of and those that will arise in the future."

"Clinical trials will provide further evidence on the effectiveness of variant vaccines."

The studies compared the Beta (B.1.351)-directed vaccine to Novavax's prototype vaccine candidate as a standalone, in combination, and heterologous prime-boost vaccine. The findings show a broad array of cellular and humoral responses in animal models against all virus strains evaluated. The Alpha (B.1.1.7) and Beta (B.1.351) variant strains have created public health concerns due to increased transmission rates and lower efficacy of current vaccines seen against Beta (B.1.351).

Gaithersburg, MD-based Novavax, Inc. (NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. 

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Jun 13, 2021 • 8:37 am CDT

The Global Polio Eradication Initiative (GPEI) recently launched the Polio Eradication Strategy 2022-2026: Delivering on a Promise at a virtual event to overcome the remaining challenges to ending polio.

While polio cases have fallen 99.9% since 1988, polio remains a Public Health Emergency of International Concern, and persistent barriers to reaching every child with polio vaccines and the pandemic have contributed to an increase in polio cases.

During 2020, there were over 1,200 cases of all forms of polio recorded compared to just 138 in 2018, according to the WHO.

On June 10, 2021, leaders from the two countries yet to interrupt wild polio transmission, Pakistan and Afghanistan, called for renewed global solidarity and the continued resources necessary to eradicate this vaccine-preventable disease.

Since 2000, the inactivated polio vaccine is most often given in the USA. It is administered by a shot in the arm or leg, depending on the person’s age, says the U.S. CDC.

The CDC recommends that children get polio vaccinated to protect against poliomyelitis. The CDC's Advisory Committee on Immunization Practices Vaccine Recommendations is published on this webpage.

On June 11, 2021, the CDC issued Level 2 Travel Alerts for Africa and Asia regarding active polio outbreaks.

Jun 11, 2021 • 1:58 pm CDT

The US Centers for Disease Control and Prevention (CDC) confirmed today, the 2020-2021 flu season in the USA is coming to a quiet close. However, one age group has been found infectious with influenza viruses.

As of Week #22, ending June 5, 2021, the 0–4 years group reported increasing flu cases, while the remaining age groups were stable (change of ≤0.1%) compared with week #21.

The good news reported by the CDC is only (1) influenza-associated pediatric death has occurred during the 2020-2021 flu season.

And mortality surveillance data available on June 10, 2021, reveals 7.5% of the deaths during week #22 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 1,360 PIC deaths reported, 661 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and two listed influenza, indicating that current PIC mortality is due primarily to COVID-19 and not influenza. 

Jun 11, 2021 • 1:18 pm CDT

The U.S. COVID-19 Vaccination Program began in December 2020, and as of June 10, 305.7 million vaccine doses have been administered, reported the U.S. Centers for Disease Control and Prevention (CDC) on June 11, 2021.

Overall, about 42.6% of the total U.S. population has been fully vaccinated.

And, the COVID Data Tracker Vaccination Demographic Trends tab shows that 75.8% of people over 65 are fully vaccinated. 

However, as of June 10th, the 7-day average number of administered vaccine doses reported to CDC per day was 1.1 million, a 13.87% increase from the previous week.

Moreover, the U.S. VAERS had received reports of myocarditis or pericarditis among people ages 30 and younger who received a COVID-19 vaccine. Through follow-up, including medical record reviews, the CDC and FDA have confirmed 268 reports of myocarditis or pericarditis.

Additionally, through June 7th, VAERS received 5,208 reports of death among people who received a COVID-19 vaccine. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines, says the CDC.

Jun 11, 2021 • 9:11 am CDT

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines.

“The past few months have really brought home to us all the importance of confidence in COVID-19 vaccines,” stated Emer Cooke, Chair of ICMRA and the European Medicines Agency Executive Director, in a press statement issued on June 11, 2021.

“As mass vaccination campaigns continue to be rolled out, ICMRA and the WHO reaffirm their commitment to support healthcare professionals and reassure members of the public that the regulatory processes for the authorization and safety monitoring of COVID-19 vaccines are robust and driven by patient needs.”

In their joint statement, international regulators and WHO reiterates that COVID-19 vaccines undergo an extensive scientific evaluation to determine their safety, efficacy, and quality.

They also explain the measures already implemented that empower regulators to collect emerging data on vaccine safety from a wide range of sources and to take swift regulatory action to protect public health whenever needed.

The ICMRA and WHO urge healthcare professionals to diligently report adverse events they see in their patients and encourage vaccinated people to report any side effects they might experience immediately.

By doing this, regulators can assess any possible link with the vaccines and ensure that the vaccines are used most safely, said the ICMRA.

As of June 11, 2021, there are sixteen COVID-19 vaccines in use globally, with about 100 vaccine candidates in development.

Jun 11, 2021 • 8:20 am CDT

As part of the National Month of Action, Illinois-based Walgreens announced on June 10, 2021, it will extend pharmacy hours of operation each Friday to offer those who may have limited time the flexibility needed to get a COVID-19 vaccination.

On Friday, June 11, 18, and 25, 2021, about 4,000 Walgreens pharmacy locations in the USA will extend hours of operation for walk-in vaccinations.

Individuals can visit the Walgreens online store locator for updated pharmacy hours of operation. Additionally, Walgreens has more than 400 24-hour pharmacy locations across the country where individuals can receive a COVID-19 vaccine on a walk-in basis.

Walgreens, part of the Walgreens Boots Alliance, Inc., operates more than 9,000 retail locations across America, Puerto Rico, and the U.S. Virgin Islands, serving approximately 8 million customers each day. 

Jun 10, 2021 • 8:56 pm CDT

New Jersey-based Johnson & Johnson issued a statement on June 10, 2021, regarding the U.S. Food and Drug Administration (FDA) authorization for extending the shelf life for the Johnson & Johnson COVID-19 Janssen vaccine from 3 months to 4.5 months.

'The FDA's decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

'A single-shot vaccine that provides protection and prevents hospitalization and death is an important tool in the global fight against COVID-19. Evidence from our Phase 3 ENSEMBLE study demonstrates the efficacy of our single-shot COVID-19 vaccine, including against viral variants that are highly prevalent. Regardless of race and ethnicity, age, geographic location, and comorbidities, these results remain consistent.'

'We continue to work with the U.S. government and health authorities to support the use of our vaccine, which plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot,' concluded Johnson & Johnson's comments.

Vaccine providers should visit www.vaxcheck.jnj to confirm the latest expiration dates of this vaccine, including those currently available for administration throughout the USA.

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

Janssen COVID-19 (Ad26.COV2.S) single-shot vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.

Jun 10, 2021 • 3:08 pm CDT

Massachusetts-based Moderna, Inc. announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).

The Moderna COVID-19 Vaccine is currently Authorized for use under a EUA for active immunization to prevent COVID-19 caused by the SARS-CoV-2 beta coronavirus in individuals 18 years of age and older.

In May 2021, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. However, the Moderna COVID-19 Vaccine may not protect all vaccine recipients.

Stéphane Bancel, CEO of Moderna, stated in a press release issued on June 10, 2021, “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents."

"We have already filed for authorization with Health Canada and the European Medicines Agency, and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center. 

Cambridge, MA-based Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.

Jun 10, 2021 • 1:20 pm CDT

New York-based Pfizer Inc. and BioNTech SE announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the co-produced COVID-19 vaccine. The U.S. government will, in turn, donate these vaccines to low- and lower-middle-income countries and organizations.

These vaccine doses are part of Pfizer and BioNTech’s previously announced pledge to provide two billion doses of the COVID-19 vaccine to low- and middle-income countries over the next 18 months.

“Today’s agreement underlines that the joint efforts of the private and the public sector are providing solutions to help end this pandemic,” stated Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, in a press statement issued on June 10, 2021.

“We are also committed to realizing sustainable solutions by supporting the establishment of manufacturing networks on various continents. Our first step has been the establishment of our Regional Headquarters for southeast Asia in Singapore, which will also include mRNA manufacturing capacities for regional and global supply."

"It is our goal to leverage our proprietary mRNA technology to help improve the health of people around the world.”

Deliveries of the 200 million doses will begin in August 2021 and continue through the remainder of the year. The 300 million doses for 2022 will be delivered between January and the end of June 2022. The U.S. government also has the option for additional doses in 2022, stated today's press release.

Pfizer and BioNTech have an existing agreement to supply vaccine doses to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and World Health Organization.

Based in Mainz, Germany, Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

Jun 10, 2021 • 11:38 am CDT

Pennsylvania-based Ocugen, Inc. announced on June 10, 2021, that following a recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN™.

Therefore, the Company will no longer pursue an Emergency Use Authorization (EUA) for the Covaxin vaccine developed by India-based Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.

Covaxin is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

Additionally, the FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and requested additional information and data. The Company anticipates that data from an additional clinical trial will be required to support the BLA submission.

“While this (recommendation) will extend our timelines, we are committed to bringing Covxin to the USA," said Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen, in a press statement.

"This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect the USA population in the long term."

Ocugen recently announced that it secured exclusive rights to commercialize Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval. 

Malvern, PA-based Ocugen, Inc. (NASDAQ: OCGN) is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19.