Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

May 14, 2021 • 2:05 pm CDT

In September 2019, the American Immunization Registry Association (AIRA) was awarded a cooperative agreement with the U.S. CDC to inform strategies for improving awareness and utilization of immunization information systems (IIS) among adult health care providers.

By the end of 2020, all US states and jurisdictions had a functional lifespan IIS with the capability and authority to collect and capture adult immunization data.

Data from the 2019 IIS Annual Report (IISAR) indicate that approximately 60% of adults aged 19 years and older are represented in an IIS with one or more recorded vaccinations compared to approximately 95% for children and 82% of adolescents, respectively.

While findings from the AIRA adult IIS capture survey indicated that approximately 63% of jurisdictions actively and routinely capture adult vaccination data.

Several immunization / IIS programs have chosen to prioritize adult vaccination activities and successfully use their IIS to support and facilitate these efforts, whereas some jurisdictions have done very little.

Documenting receipt of a vaccine has also been included as a Healthy People 2030 developmental objective to “increase the proportion of people with vaccination records in an information system.”

This new Landscape Analysis Report provides the insight needed to establish a Strategic Road Map for prioritizing and advancing adult data capture and utilization nationally across all jurisdictions.

Located in Washington DC, the American Immunization Registry Association exists to support and promote the use of immunization information to ensure healthy communities through the development and implementation of immunization information systems as a crucial tool in preventing vaccine-preventable diseases.

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May 14, 2021 • 1:32 pm CDT

The US Centers for Disease Control and Prevention (CDC) reported since COVID-19 vaccinations began in the USA on December 14, 2020, about 266 million vaccine doses have been administered as of May 13, 2021.

Overall, 35.8% of the total U.S. population have been fully vaccinated.

The updated COVID Data Tracker Vaccination Demographic Trends tab shows vaccination trends by age group. Of those most at risk for severe COVID-19, 84% of people ages 65 or older have received at least one dose of vaccine.

Earlier this week, the Food and Drug Administrationexternal (FDA) issued an Emergency Use Authorization for the experimental Pfizer-BioNTech COVID-19 Vaccine for use in adolescents aged 12-15 years.

Then on May 14th, the CDC’s Advisory Committee on Immunization Practices unanimously voted to support the FDA's decision.

Currently, there are three COVID-19 vaccines Authorized in the USA.

Additionally, the CDC announced that fully vaccinated people, including adolescents, no longer need to wear face masks in most situations.

Additionally, VAERS, the system that monitors vaccine safety, reported from December 14th through May 10, 2021, there have been 4,434 reports of death among people who received a COVID-19 vaccine. The CDC and FDA review each case of death and request medical records to assess the report further. 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.

The CDC also has resources on credible vaccine information and support for teens and young adults facing challenges during the COVID-19 pandemic.

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May 14, 2021 • 8:56 am CDT

Mixing COVID-19 vaccines may produce more frequent mild to moderate reactions than standard vaccine dosing schedules, University of Oxford researchers reported in a peer-reviewed research letter published in The Lancet on May 12, 2021.

This study compared all four prime and boost permutations of the AstraZeneca and the Pfizer-BioNTech vaccines (Pfizer followed by AstraZeneca, AstraZeneca followed by Pfizer, AstraZeneca twice unmixed, and Pfizer twice unmixed) both at 28 days and 84-day, prime-boost intervals in 830 individuals.

'Both heterologous vaccine schedules induced greater systemic reactogenicity following the boost dose than their homologous counterparts, with feverishness reported by 37 (34%) of 110 recipients of ChAd for prime and BNT for boost compared with 11 (10%) of 112 recipients of ChAd for both prime and boost (difference 24%, 95% CI 13-35%).'

'Feverishness was reported by 47 (41%) of 114 recipients of BNT for prime and ChAd for boost, compared with 24 (21%) of 112 recipients of BNT for both prime and boost (difference 21%, 95% CI 8-33%).'

'Similar increases were observed for chills, fatigue, headache, joint pain, malaise, and muscle ache. There were no hospitalizations due to solicited symptoms, and most of this increase in reactogenicity was observed in the 48 hours after immunization.'

Matthew Snape, associate professor in pediatrics and vaccinology at the University of Oxford, said in a related BMJ article published on May 13th, “... it is important that we inform people about these data, especially as these mixed doses schedules are being considered in several countries."

“The results from this study suggest that mixed dose schedules could result in an increase in work absences the day after immunization, and this is important to consider when planning immunization of healthcare workers.”

May 14, 2021 • 8:01 am CDT

In an exploratory analysis published by The Lancet on May 13, 2021, receipt of a COVID-19 mRNA vaccine was found immunogenic in pregnant women.

Additionally, COVID-19 vaccine-elicited antibodies were transported to infant cord blood and breast milk.

These pregnant and nonpregnant women who received either the U.S. FDA Authorized mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.

This study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional non-neutralizing antibody responses and CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination.

Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants.

This study was funded by grant CA260476 from the National Institutes of Health (NIH), and grants from the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, Harvard, the Massachusetts Consortium for Pathogen Readiness, and the Musk Foundation (DHB); AI146779 from the NIH (AGS); HD000849 from the Reproductive Scientist Development Program from the Eunice Kennedy Shriver National Institute of Child Health & Human Development and Burroughs Wellcome Fund (AYC), AI007387 from the Multidisciplinary AIDS Training Program (LHT), and TR002541 from the Harvard Clinical and Translational Science Center (MRH).

The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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May 14, 2021 • 7:31 am CDT

The New York Yankees announced on May 13, 2021, eight previously vaccinated members of their organization have been diagnosed with COVID-19 .

Major League Baseball (MLB), its medical experts, and the New York State Department of Health are currently advising and assisting the Yankees, who continue to undergo additional testing and contact tracing, stated an MLB news release.

All of the positives cases are classified as Breakthrough Infections, occurring with fully vaccinated individuals with a U.S. FDA Authorized COVID-19 vaccine.

As of April 26, 2021, the total COVID-19 vaccine Breakthrough Infections reported to the U.S. CDC was 9,245.

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May 13, 2021 • 2:39 pm CDT

The US Centers for Disease Control and Prevention (CDC) announced today 'if you are fully vaccinated, you can resume activities you did before the COVID-19 pandemic began in December 2019.

And, the CDC says 'fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.'

'Fully vaccinated people can refrain from testing following a known exposure unless they are residents or employees of a correctional or detention facility or a homeless shelter. Furthermore, the three U.S. FDA Authorized 'COVID-19 vaccines are effective at protecting you from getting sick.'

These Authorized COVID-19 vaccines have been administered to 116,387,534 people over 18 years of age as of May 12, 2021. This data represents about 45.1% of the US population.

And to protect more people, the U.S. Food and Drug Administration expanded the emergency use authorization for the experimental Pfizer-BioNTech COVID-19 Vaccine on May 10th to include adolescents 12 through 15 years of age.

'These recommendations can help you make decisions about daily activities after you are fully vaccinated. But, they are not intended for healthcare settings.' stated the CDC.

This CDC guidance applies to people intending to travel domestically and abroad. The COVID-19 vaccines currently authorized for emergency use by the U.S. FDA are the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines. The CDC travel guidance can also be applied to COVID-19 vaccines that have been authorized by the World Health Organization, which are list on this webpage.

Moreover, if you have a condition or are taking medications that weaken your immune system, you may NOT be fully protected even if you are fully vaccinated. Even after vaccination, you may need to continue taking all precautions. Talk to your healthcare provider, suggests the CDC.

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May 13, 2021 • 10:20 am CDT

The European Center for Disease Prevention and Control (ECDC) announced on May 12, 2021, key figures on the COVID-19 vaccine rollout in the EU/EEA as of week #18 (May 9, 2021).

These highlights include, but are not limited to the following:

  • The total number of vaccine doses distributed by manufacturers to EU/EEA countries: 209,090,038 (29 countries reporting).
  • Cumulative uptake of full vaccination among adults aged 18 years and above: median of 13.3% (30 countries reporting).
  • This graph shows the cumulative number of full vaccinations among adults (aged 18 years and above) in EU/EEA countries as a percentage over the country population aged 18 years and above.

As of May 13, 2021, the European Medicines Agency had authorized four COVID-19 vaccines for use in the EU, which are: Comirnaty (BioNTech-Pfizer), COVID-19 Vaccine Moderna, Vaxzevria (previously AstraZeneca), and J&J's COVID-19 Vaccine Janssen.

About (99) COVID-19 vaccine candidates are undergoing clinical trials and 184 pre-clinical vaccines are in development, reported GAVI.org on May 12, 2021.

The data presented in this ECDC report are collected through The European Surveillance System.

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May 13, 2021 • 8:50 am CDT

An acute loss of smell is one of the most common symptoms of COVID-19, but for two decades, it has been linked to other maladies, among them Parkinson's disease and dementia. Now, a poor sense of smell may signify a higher risk of pneumonia in older adults, stated a team of Michigan State University (MSU) researchers on May 11, 2021.

In a first-of-its-kind study, this MSU team found a possible link between a poor sense of smell and a higher risk of pneumonia hospitalization.

They analyzed 13 years of health data from 2,494 older adults, ages 71-82, from metropolitan areas of Pittsburgh, Pennsylvania, and Memphis, Tennessee. This study aimed to examine whether a poor sense of smell in older adults is associated with a higher future risk of developing pneumonia.

"About a quarter of adults 65 years or older have a poor sense of smell," said Honglei Chen, a professor in the Department of Epidemiology and Biostatistics within MSU's College of Human Medicine press statement.

"Unlike vision or hearing impairment, this sensory deficit has been largely neglected; more than two-thirds of people with a poor sense of smell do not know they have it."

'To the best of our knowledge, this study provides the first epidemiological evidence that poor olfaction in older adults is associated with a higher risk of pneumonia. It is estimated that 15–25% of older adults in the USA have poor olfaction.'

'Our study also has several limitations. First, our study participants were older than 70 years at the time of olfaction testing, which might limit the generalisability of our study findings to older adults who are relatively younger. Future studies should independently confirm this observation, investigate potential mechanisms, and understand its implications on the health of older adults.'

A start-up fund from the MSU supported this study. The NIA supported the Health ABC study, the National Institute of Nursing Research, the Intramural Research Program of the NIA/National Institutes of Health, and NIA contracts N01AG62101, N01AG62103, N01AG62106, NIA grant R01AG028050, and NINR grant R01NR012459.

Chen's research was published in the journal The Lancet Healthy Longevity on May 6, 2021.

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May 13, 2021 • 8:25 am CDT

An Ebola vaccination launched in the Republic of Sierra Leone as the central African country takes proactive public health measures to protect its high-risk residents from the potential cross-border transmission of the Ebola virus disease (EVD) from Guinea. The Ebola virus is a zoonotic pathogen that causes severe hemorrhagic fever in humans, says the U.S. CDC.

The World Health Organization (WHO) announced on May 11, 2021, Ebola vaccinations were launched in Kambia District, a primary international point of entry for Guinea and Sierra Leone. This preventive Ebola vaccination will continue over the coming days in eight other districts sharing borders with Guinea.

About 16 000 people have been targeted for vaccination in the selected border districts, and individuals will receive two doses of the vaccine given approximately eight weeks apart.

The Ministry of Health and Sanitation is leading the exercise to administer the Johnson & Johnson vaccine known as Zabdeno and Mvabea. The Janssen Ebola prevention vaccine therapy consists of 2 components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first, and Mvabea is administered approximately 8-weeks later as a booster. In 2016, the Ebola vaccination was piloted in Sierra Leone during the country’s devastating outbreak, resulting in nearly 11,000 cases with some 4,000 related fatalities.

Previously, the Ministry of Health and Sanitation launched a comprehensive Ebola Outbreak Preparedness and Contingency Plan on April 7, 2021, to guide its readiness activities for its 7 million residents. Sierra Leone is bordered on the north and east by Guinea, on the south by Liberia, and on the west by the Atlantic Ocean, reports Britannica

According to various WHO reports, the 12th Ebola Outbreak in west-central African is ending.

In December 2019, the U.S. Food and Drug Administration announced the approval of Ervebo for the prevention of EVD caused by Zaire ebolavirus in individuals 18 years of age and older.

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May 12, 2021 • 11:04 am CDT

Cambridge-based Moderna, Inc. announced today a new supply agreement with the government of Australia for 25 million COVID-19 vaccine doses.

This new order includes 10 million doses of Moderna’s experimental COVID-19 vaccine against the ancestral strain (mRNA-1273) delivered in 2021 and 15 million doses of Moderna’s updated variant booster vaccine candidate (mRNA-1273.351) to be delivered in 2022.

Stéphane Bancel, CEO of Moderna, stated in a press release, “As we seek to protect people around the world with our COVID-19 vaccine and potentially our variant booster candidates, we look forward to continuing discussions with Australia about establishing potential local manufacturing opportunities.”

Initial data from Moderna’s Phase 2 study in the U.S. showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).

A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 Variant of Concern than a booster dose of mRNA-1273.

Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 previously reported Phase 2 and Phase 3 studies.

The Moderna COVID-19 vaccine has been Authorized but not Approved by the U.S. FDA.

Massachusetts-based Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. It has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 14 programs have entered the clinic.

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May 12, 2021 • 10:12 am CDT

The U.S. CDC's ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)'s emergency meeting agenda and presentation slides were posted on May 12, 2021.

The focus of this ACIP is on the recently Authorized Safety, immunogenicity, and efficacy of Pfizer - BioNTech COVID-19 Vaccine (BNT162b2) in persons aged 12-15 years.

This meeting's agenda is posted here. And the presentation slides are available at this weblink.

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May 12, 2021 • 9:52 am CDT

As of May 12, 2021, three experimental COVID-19 vaccines have been Authorized for emergency use in the USA.

Since December 11, 2020, the U.S. CDC had reported 116,576,359 people had been fully vaccinated against COVID-19. This data represents about 35.1% of the US population.

As of April 26, 2021, the total number of COVID-19 vaccine Breakthrough Infections (post-vaccination infection) reported to the CDC was 9,245.

Additionally, the USA's early warning system that monitors the safety of vaccines after they are authorized or licensed for use is the Vaccine Adverse Event Reporting System (VAERS).

From December 14, 2020, through May 10, 2021, VAERS received 4,434 reports of death (0.0017%) among people who received a COVID-19 vaccine.

However, VAERS reports cannot prove that a vaccine caused a problem.

CDC and FDA physicians review each case report of death as soon as notified, and the CDC requests medical records to assess these fatal cases further. 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's website, as of May 11, 2021.

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May 12, 2021 • 8:25 am CDT

Massachusetts-based VBI Vaccines Inc. announced today The Lancet published results from the pivotal Phase 3 study, PROTECT, of the company's prophylactic 3-antigen hepatitis B (HBV) vaccine candidate (Sci-B-Vac) in adults.

The study was designed to compare the immunogenicity and safety of 10 µg of VBI’s 3-antigen vaccine candidate to 20 µg of the single-antigen HBV vaccine, Engerix-B®.

'Regardless of age, BMI, or diabetic status, participants who received the Sci-B-Vac vaccine candidate achieved higher seroprotection rates, and 5-8x higher antibody geometric mean concentration (GMC) compared to Engerix-B®. And, no safety signals were observed.'

Together with results from the second pivotal Phase 3 study, CONSTANT, these results form the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S. and Europe, which were submitted in November 2020, and for Canada and the U.K., which are in process, said the company.

Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies, and author of the manuscript commented in a press statement, “While HBV immunization programs effectively address infants, large immunization gaps exist in certain adult populations, due in large part to the poor immune response in many risk groups such as older adults, people with diabetes or kidney disease, overweight adults, and those who smoke."

"The PROTECT study demonstrated that the 3-antigen hepatitis B vaccine may be able to overcome some of the limitations of conventional single-antigen HBV vaccines in adults, particularly in older adults age 45+ where superior immune responses were achieved.”

The Lancet's Interpretation of the VBI funded study was: 'The safety and efficacy of the tri-antigenic hepatitis B vaccine show its usefulness for the prevention of HBV infection in adults, including those with stable and controlled chronic conditions.'

VBI Vaccines Inc. is an international biopharmaceutical company driven by immunology to pursue powerful prevention and treatment of disease. 

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May 12, 2021 • 7:58 am CDT

Pennsylvania-based INOVIO announced today that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies and T cell responses against the original Wuhan strain of the SARS-CoV-2 coronavirus as well as against B.1.1.7 (UK variant), B.1.351 (South African variant), and P.1. (Brazilian variant) in preclinical (animal) models.

The non-peer-reviewed study was published on May 11, 2021.

The company stated in a press release, 'these results demonstrate the potential of INOVIO's Pan-COVID-19 vaccine to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine or potentially as a boost for individuals previously immunized with various Wuhan-matched vaccines.'

Dr. Laurent M. Humeau, INOVIO's Chief Scientific Officer, commented, "INOVIO is taking a dual-track approach in developing a COVID-19 vaccine because we recognize the need to support both pandemic and endemic considerations."

"In addition to our work on INO-4800, which we expect to enter a global Phase 3 trial this summer, we are also developing our next-generation Pan-COVID-19 variant vaccine, INO-4802, which is designed to protect against current and potential future Variants of Concern."

The INO-4800 vaccine candidate contains the plasmid pGX9501, which encodes for the entire length of the Spike glycoprotein of SARS-CoV-2. Once inside the cell, the plasmids begin replicating, strengthening the body's own natural response mechanisms, says the company.

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV.

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May 11, 2021 • 8:39 am CDT

Thanks to the Pneumococcal Advance Market Commitment (AMC), children in 60 Gavi-eligible countries are being immunized against the main cause of pneumonia with pneumococcal vaccines, stated Gavi, the Vaccine Alliance.

The purpose of the twelfth and final Pneumococcal AMC Annual Report is to provide an update on the implementation activities for pneumococcal vaccines, including supply and procurement, country demand, and financial reporting.

This final report covers the period from January to December 2020, completing a decade of unprecedented progress in pneumococcal disease prevention, mainly fuelled by the expansion of routine immunization in Gavi countries.

A total of 139 million doses of pneumococcal conjugate vaccine (PCV) were procured through the AMC in 2020, a 14% decrease from 2019.

In the second half of 2021, an appendix to this report will be issued to reflect the 2020 data scheduled to be published in July 2021, including PCV coverage achieved in 2020.

Pneumococcal vaccines prevent pneumococcal disease caused by Streptococcus pneumoniae, a bacterium with more than 90 serotypes, says the U.S. CDC. The CDC's Advisory Committee on Immunization Practices vaccine recommendations is published on this webpage.

The overall likelihood of approval of Phase I pneumococcal vaccine is 16.7%, and the average probability a vaccine advances from Phase III is 75%. Pneumococcal vaccines, on average, take 8.6 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space, reported ResearchAndMarkets.com in April 2021.

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