Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Mar 2, 2021 • 4:56 am CST

England-based AstraZeneca plc disclosed it recorded $1.38 billion in equity portfolio sales in 2020, with "a large proportion" of cash coming from the sales of Massachusetts-based Moderna Inc. sale, according to the company's recent annual report.

AstraZeneca and Moderna are rivals in the very competitive COVID-19 vaccine market segment.

Previously, Merck disclosed it too sold shares on Moderna in December 2020.

Mar 1, 2021 • 10:41 am CST

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization on March 1, 2021, for the Quidel QuickVue At-Home COVID-19 Test.

This is another antigen test where certain individuals can rapidly collect and test their sample at home without sending a sample to a laboratory for analysis, says the FDA.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal swabs from individuals ages 14 and older or individuals ages 8 and older swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” commented Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press statement.

In addition to this new prescription home test, Quidel also was issued emergency authorization in December 2020 for their QuickVue SARS Antigen Test for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate, or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

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

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Mar 1, 2021 • 8:14 am CST

Massachusetts-based CARB-X announced it is funding the GSK Biologicals and its affiliate GSK Vaccines Institute for Global Health (GVGH), based in Siena, Italy, to develop new vaccines to prevent serious infections caused by two different pathogens, for which there are no U.S. FDA authorized vaccines.

Together, the two awards could be worth potentially more than $18 million if project milestones are met, subject to available funding.

GSK’s two vaccine projects in the preclinical stage target the prevention of the following:

  • Group A Streptococcus (Strep A) infections, commonly known as Strep Throat, a major reason for antibiotic prescriptions and cause of immune-mediated diseases. The CARB-X award is worth up to $8.2 million, plus up to an additional $4.2 million if the project meets certain milestones.
  • Infections caused by Salmonella enterica, which cause Invasive nontyphoidal salmonellosis (iNTS) disease and typhoid fever, major causes of death among children and significant health challenges primarily in sub-Saharan African countries. Salmonella enterica is listed by the World Health Organization (WHO) as among those bacteria that pose the greatest threat to human health. The CARB-X award is for $2.2 million to support the development of this new vaccine. If project milestones are met, the project could be eligible for up to $4.0 million in additional funding.

“Vaccines are powerful weapons in the global fight against antibiotic-resistant bacteria. Vaccines not only prevent infections, but they also reduce the need for antibiotics, helping to curb the spread of drug resistance,” commented Erin Duffy, R&D Chief of CARB-X, in a press statement.

The WHO estimates that 700,000 people die each year from antibiotic-resistant infections, including 35,000 in the US and 33,000 in Europe. 

CARB-X is a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative therapeutics, preventatives, and diagnostics to address antibiotic-resistant bacterial infections. The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 54 active projects focused exclusively on drug-resistant bacteria. Since its launch in 2016, CARB-X has announced 80 awards worth more than $299.8 million, with the potential of additional funds if project milestones are met.

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Feb 28, 2021 • 8:05 pm CST

As of February 28, 2021, the U.S. Center for Disease Control and Prevention reported 49,772,180 first-dose COVID-19 vaccines had been administered in the USA. Furthermore, the number of people receiving a second vaccine dose has reached 24,779,920 in less than three months.

According to Our World in Data, the USA leads all other countries with over 72 million vaccine doses administered, with the UK reporting about 20.4 million vaccine doses administered.

The USA has now authorized three experimental COVID-19 vaccines. Authorization for the Johnson and Johnson Janssen COVID-19 vaccine was issued on February 27, 2021. 

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Feb 28, 2021 • 8:30 am CST

Health Canada announced on February 26, 2021, it had authorized two vaccines the COVID-19 vaccine manufactured by AstraZeneca and developed in partnership with Oxford University and the Serum Institute of India’s version of the AstraZeneca vaccine. 

After thorough, independent reviews of the evidence, the Department has determined that these vaccines meet Canada’s stringent safety, efficacy, and quality requirements said the announcement.

These are the first viral vector-based COVID-19 vaccines authorized in Canada. The vaccines are authorized for use in people over 18 years of age. They are administered as a two-dose regimen and can be kept at refrigerated temperatures (from 2˚ to 8˚C) for at least six months, facilitating distribution across the country.

Health Canada’s authorization of the Verity Pharmaceuticals Inc./Serum Institute of India product relies on the assessment of its comparability to the AstraZeneca-produced version of the vaccine.

Following Health Canada's authorization, the Honourable Anita Anand, Minister of Public Services and Procurement, announced that Canada had secured 2 million doses of the AstraZeneca COVID-19 vaccine through an agreement with Verity Pharmaceuticals Canada Inc./Serum Institute of India.

"We remain fully on track to ensure that there will be a sufficient supply so that every eligible Canadian who wants a vaccine will have access to one by the end of September. I am grateful for the collaboration of our partners in India to finalize this agreement, and I look forward to continuing to work closely together in the weeks ahead," stated the Honourable Anita Anand in a press release.

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Feb 27, 2021 • 6:34 pm CST

The U.S. Food and Drug Administration (FDA) announced it had issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

The FDA determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of a EUA.

The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may effectively prevent COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

This is the third EUA issued by the FDA for the prevention of COVID-19 caused by SARS-CoV-2.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” stated Acting FDA Commissioner Janet Woodcock, M.D., in a related press release on February 27, 2021.

The Janssen COVID-19 Vaccine is manufactured using a specific type of adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of relatively common viruses, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine to not replicate in the human body to cause illness.

After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” added Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics to prevent and treat COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

The FDA had previously issued EUA for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine.

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Feb 27, 2021 • 3:52 pm CST

Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants appear and start infecting people, says the US Centers for Disease Control and Prevention (CDC).

As of February 25, 2021, the CDC reported the following number of SARS-CoV-2 variant cases confirmed in the USA:

  • UK B.1.1.7 = 2,102
  • South Africa B.1.351 = 49
  • Brazil P.1 = 6

Recently, the JAMA published a study on February 17, 2021, focused on SARS-CoV-2 Variants of Concern in the United States: Challenges and Opportunities. This article concluded by saying, 'a concerted and well-coordinated public health effort is essential to remain ahead of the inevitable evolution of variants that could dangerously accelerate the trajectory of the COVID-19 pandemic.'

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Feb 27, 2021 • 1:00 pm CST

Russian Direct Investment Fund (RDIF), JSC Generium, and RUE Belmedpreparaty, the largest pharmaceutical company in the Republic of Belarus, announced on February 26, 2021, the production launch of the Sputnik V vaccine.

The Sputnik V vaccine's release at the sites of the Belmedpreparaty enterprise will fully meet the need of Belarus for a vaccine against coronavirus.

Denis Manturov, Minister of Industry and Trade of the Russian Federation, commented in a press statement, “The joint production of the Sputnik V vaccine is an important stage in cooperation between our countries. Industrial cooperation and the development of cooperation make it possible to implement such significant joint projects for the effective protection of the population of the Republic of Belarus."

"Assistance in technology transfer is provided by the Gamaleya Institute, Generium, and RDIF."

Kirill Dmitriev, CEO of the RDIF, added, “The Republic of Belarus became the first foreign country to start clinical trials of Sputnik V, register the drug and start vaccination. Establishing their own production will significantly increase the scale of vaccination in the absence of logistics costs."

The Sputnik V vaccine is based on the well-studied platform of human adenoviral vectors, which cause the common cold. It uses two different vectors for two shots during the vaccination process, which creates more robust immunity compared to vaccines that use the same delivery mechanism for both shots.

Feb 27, 2021 • 6:06 am CST

The US Food and Drug Administration Acting Commissioner Janet Woodcock M.D. and the Director of the Center for Biologics Evaluation and Research Peter Marks M.D., Ph.D., issued the following statement late on February 26, 2021.

'Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.'

This positive statement followed the FDA's Vaccines and Related Biological Products Advisory Committee's 22-0 vote supporting the benefits of the experimental vaccine 'outweigh its risks for use in individuals 18 years of age and older.'

The Janssen COVID-19 vaccine (Ad26.COV2-S) is an experimental vaccine that 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. Adenoviruses are a group of viruses that can cause the common cold.

On February 18, 2021, South Africa announced it launched a vaccination program with the Janssen COVID-19 vaccine.

Janssen Biotech Inc. is the vaccine division of the New Jersey-based Johnson and Johnson companies.

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Feb 26, 2021 • 12:24 pm CST

The COVID-19 vaccine development landscape includes innovative platforms such as DNA, RNA, virus-like particle, peptide, viral vector, recombinant protein, live attenuated virus, and inactivated virus approaches.

As of February 25, 2021, the U.S. CDC reported 46,074,392 first-dose vaccines had been administered, and the number of people receiving 2 vaccine doses has reached 21,555,117.

And, according to Our World in Data, the USA leads all other countries with over 68 million vaccine doses administered with the UK reporting about 19.3 million vaccine doses administered.

Throughout the world, there are eleven different COVID-19 vaccines being administered, with several vaccine candidates pending authorization in late-stage clinical studies.

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Feb 26, 2021 • 10:39 am CST

The US Centers for Disease Control and Prevention (CDC) said 'seasonal influenza activity in the United States remains lower than usual for this time of year.'

On February 26, 2021, the CDC reported the results of tests performed by public health laboratories during week #7 during the 2020-2021 flu season in the USA. The CDC confirmed two specimens out of 12,280 tested specimens were found to be infected with influenza viruses. The influenza A subtype was identified in the two positive specimens.

Furthermore, between October 2020 and February 20, 2021, FluSurv-Net sites in 14 states reported 183 laboratory-confirmed influenza hospitalizations for an overall cumulative hospitalization rate of 0.6 per 100,000 population.

'This is much lower than average for this point in the fly season and lower than rates for any season since routine data collection began in 2005,' stated the CDC.

The CDC says 'an annual flu vaccine is the best way to protect against flu and its potentially serious complications. If you haven’t gotten your flu vaccine yet, get vaccinated now.'

A list of available flu vaccines and related news can be found on this webpage.

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Feb 26, 2021 • 5:35 am CST

The U.S. Food and Drug Administration announced on February 25, 2021, that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.

This change reflects an alternative to the undiluted vials' preferred storage in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccines to more sites,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement.

Pfizer Inc. had submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days) or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours).

The updated Fact Sheets for Health Care Providers Administering Vaccine are intended to help frontline workers understand the new alternative transportation and storage temperatures.

The FDA is an agency within the U.S. Department of Health and Human Services protecting 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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Feb 25, 2021 • 6:35 pm CST

Germany-based BioNTech SE and Pfizer Inc. announced today they had begun evaluating the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.

The study will draw upon participants from the Phase 1 study in the USA who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen.

The study is part of the Companies’ clinical development strategy to determine the effectiveness of the third dose against evolving variants.

Separately, to be prepared for any potential future strain changes, Pfizer and BioNTech are in ongoing discussions with regulatory authorities regarding a registration-enabling clinical study to evaluate a variant-specific vaccine having a modified mRNA sequence. This study would use a new construct of the Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified in South Africa.

This could position the Companies to update the current vaccine quickly if the need arises to protect against COVID-19 from circulating strains.

“We want to be prepared for different scenarios,” stated Ugur Sahin, CEO, and Co-founder of BioNTech, in a press release. “Therefore, we will be evaluating the second booster in the current regimen as well as preparing for a potential rapid adaption of the vaccine to address new variants which might escape the current version of our mRNA-based vaccine."

"The flexibility of our proprietary mRNA vaccine platform allows us to develop booster vaccines within weeks if needed technically."

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. FDA. Still, it has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent COVID-19 for use in individuals 16 years of age and older.

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

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Feb 25, 2021 • 9:23 am CST

Rhode Island-based CVS Health announced it had added Alabama, Arizona, Florida, Louisiana, Ohio, and Pennsylvania to the list of states where select pharmacy locations will offer COVID-19 vaccinations to eligible populations through the Federal Retail Pharmacy Program.

Vaccination appointments for the latest allocation of approximately 570,000 doses will become available for booking, with vaccinations beginning February 25, 2021.

This news follows the successful rollout in 11 states: California, Connecticut, Hawaii, Maryland, Massachusetts, New Jersey, New York, Rhode Island, South Carolina, Texas, and Virginia.

"Feedback on every aspect of the vaccination process has been incredibly positive, from the digital experience to interacting with our team of health care professionals," commented Karen S. Lynch, President, and CEO, CVS Health, in a press release.

"We're also making significant progress in reaching vulnerable communities, which will continue to be an essential part of our vaccination effort."

There are nearly 10,000 CVS Pharmacy locations in the USA, with almost half located in communities ranked high or very high in the Centers for Disease Control and Prevention Social Vulnerability Index.

CVS Health is a diversified health services company with nearly 300,000 employees united around a common purpose of helping people on their path to better health.

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Feb 25, 2021 • 5:49 am CST

Massachusetts-based Moderna, Inc. announced that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 virus variant known as B.1.351 and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial.

This new study will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases.

Furthermore, Moderna is pursuing two strategies against these variants, subject to U.S. Food and Drug Administration (FDA) review.

First, the Company is evaluating booster doses of vaccines to increase neutralizing immunity against the variants of concern. Moderna plans to evaluate three approaches to boosting, including:

  • A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant was first identified in the Republic of South Africa, at the 50 µg dose level and lower.
  • A multivalent booster candidate, mRNA-1273.211, combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine at the 50 µg dose level and lower.
  • A third dose of mRNA-1273, the Moderna COVID-19 Vaccine, is a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.

Second, Moderna plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative. These candidates will be evaluated in a two-dose series at the 100 µg dose level and lower.

Consistent with the recently updated FDA Guidance for Industry, the Company plans to evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine and participants in clinical studies who previously received the mRNA-1273 vaccine.

Stéphane Bancel, CEO of Moderna, commented in a press statement issued on February 24, 2021, “Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control."

"We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. Today, 13 programs have entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years.