Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Apr 10, 2021 • 8:47 am CDT

The US Centers for Disease Control and Prevention (CDC) published Key Updates for Week #13, ending April 3, 2021, highlights 'Flu activity is unusually low at this time of year but may increase in the coming months.'

The CDC confirmed 1.0% of patient visits reported were due to Influenza-like-Illness (ILI). This ILI percentage is below the national baseline of 2.6%.

And the CDC reported the current hospitalization rate is much lower than average for this point in the annual flu season and lower than rates for any season since 2005.

Furthermore, only one influenza-associated pediatric death occurring during the 2020-2021 season has been reported to CDC. This data is far lower than most flu season, including last year when 198 influenza-associated pediatric deaths were confirmed.

The annual flu vaccine is the best way to protect against flu and its potentially serious complications. Influenza vaccines protect people against the viruses that research indicates are circulating during the flu season, says the CDC.

A list of 2020-2021 flu season vaccines is posted on this webpage. And to learn about the upcoming 2021-2022 flu season in the Southern and Northern Hemispheres, please visit this Precision Vaccinations webpage.

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Apr 9, 2021 • 4:19 pm CDT

Pfizer, Inc. and Germany-based BioNTech SE announced on April 9, 2021, they requested amendments to the U.S. Emergency Use Authorization (EUA) of the experimental Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age.

This request is based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 coronavirus infection, which demonstrated 100% efficacy and robust antibody response after vaccination with the vaccine.

The Pfizer-BioNTech COVID-19 Vaccine was issued the first U.S. Food and Drug Administration EUA for individuals 16 years of age and older on December 11, 2020. However, the Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA as of April 9th.

The companies stated they plan to request similar rulings by other regulatory authorities worldwide in the coming days. The mRNA vaccine is known as Comirinaty in various countries.

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Apr 9, 2021 • 3:03 pm CDT

The European Medicines Agency (EMA) safety committee (PRAC) announced on April 9, 2021, it has started a review of a safety signal to assess reports of thromboembolic events (formation of blood clots, resulting in the obstruction of a vessel) in people who received COVID-19 Vaccine Janssen.

The PRAC reported 'four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial, and three cases occurred during the vaccine rollout in the USA. One of them was fatal.'

These reports point to a ‘safety signal,’ but it is currently unclear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions. PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.

The COVID-19 Vaccine Janssen is currently only used in the USA, under an emergency use authorization.

COVID-19 Vaccine Janssen was authorized in the EU on March 11, 2021. The vaccine rollout has not started yet in any EU Member State but is expected in the next few weeks, stated the EMA.

 

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Apr 9, 2021 • 2:05 pm CDT

'The COVID-19 pandemic disrupted both in-person learning and routine well-child visits for many children over the last year,' commented Dr. Nancy Messonnier, Senior Official, CDC National Center for Immunization and Respiratory Diseases, in a media statement issued on April 9, 2021.

'As a result, too many children have fallen behind on receiving recommended vaccines.'

'We all want our kids to be back in school safely, and that means getting caught up on vaccines that were missed over the last year.'

According to the CDC’s public sector vaccine ordering data, there is a 14% decrease in 2020-2021 orders compared to 2019.

The most obvious decrease is the measles vaccine ordering is down by more than 20%.

Measles outbreaks occur when people who are not protected from the virus are infected and spread the disease to unvaccinated or under-vaccinated populations. According to the CDC, around 90 percent of people who are not protected will become infected following exposure to the measles virus.

'Kids need to get caught up now so that they are protected as they go back to in-person learning. Catch-up vaccination will require efforts from healthcare systems, health care providers, schools, state and local governments, and families,' concluded Dr. Messonnier.

The CDC says 'vaccination providers should adhere to the standards for child and adolescent vaccination practices. These standards are published by the National Vaccine Advisory Committee and define appropriate vaccination practices for both public and private sectors for 2021.

In the USA, the M-M-R-II vaccine is commonly available. It is indicated for simultaneous vaccination against measles, mumps, and rubella. This vaccine is usually given to people 1-year-old or older.

Globally, measles cases surged in 2019, reaching the highest level in 23 years, reported the World Health Organization (WHO). Measles fatalities climbed nearly 50 percent since 2016, claiming an estimated 207,500 lives in 2019 alone, reported the WHO on November 12, 2020.

“We know how to prevent measles outbreaks and deaths,” stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a related press statement. “These data send a clear message that we are failing to protect children from measles in every region of the world.”

“We must collectively work to support countries and engage communities to reach everyone, everywhere with measles vaccine, and stop this deadly virus.”

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Apr 9, 2021 • 10:18 am CDT

The U.S. NIH announced on April 8, 2021, anti-SARS-CoV-2 monoclonal antibodies that target the SARS-CoV-2 spike protein and block virus entry into cells have been evaluated for the treatment of COVID-19.

To date, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for the following anti-SARS-CoV-2 monoclonal antibodies and combinations:

  • bamlanivimab alone,
  • bamlanivimab plus etesevimab, and,
  • casirivimab plus imdevimab.

The NIH stated 'data are emerging on the currently available anti-SARS-CoV-2 monoclonal antibodies, including preliminary data from a Phase 3 trial of casirivimab plus imdevimab, and on the in vitro susceptibility of SARS-CoV-2 variants to anti-SARS-CoV-2 monoclonal antibodies.'

'After reviewing the available data, the COVID-19 Treatment Guidelines Panel has updated its recommendations on the use of anti-SARS-CoV-2 monoclonal antibodies in outpatients with mild to moderate COVID-19 who are at high risk of disease progression.

Also, the Panel noted on March 24, 2021, that, because of an increasing number of reports of variants that are resistant to bamlanivimab alone, this product will no longer be distributed by the U.S. government.

The FDA updated the authorized Fact Sheet for Healthcare Providers for the bamlanivimab EUA on March 2, 2021.

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Apr 9, 2021 • 9:51 am CDT

The U.S. CDC reported the number of people fully vaccinated against COVID-19 in the USA had reached 66,203,123, as of late on April 8, 2021. This CDC data represents about 19.9% of the US population have been vaccinated.

As of April 9, 2021, the US Food and Drug Administration (FDA) had authorized three experimental COVID-19 vaccines for use in the USA.

On December 11, 2020, the FDA authorized the experimental Pfizer-BioNTech COVID-19 Vaccine, known globally as Comirnaty, for Emergency Use (EUA). And on December 18, 2020, the FDA issued its second EUA for the Massachusetts-based Moderna COVID-19 Vaccine. The FDA issued a third EUA for the Johnson and Johnson Janssen COVID-19 vaccine on February 27, 2021.

The global COVID-19 vaccine landscape includes innovative platforms such as DNA, mRNA, virus-like particle, viral vector, recombinant protein, live attenuated virus, and inactivated virus approaches. In total, there are twelve COVID-19 vaccines in use by various countries.

Apr 9, 2021 • 7:27 am CDT

Pfizer Inc. recently announced it is evaluating an investigational, novel oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, which has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses.

Pfizer's press release stated on March 23, 2021, this 'suggests a potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.'

This is the first orally administered coronavirus-specific investigational protease inhibitor to evaluate in a clinical study in the USA.

Pfizer is currently evaluating an intravenously administered investigational protease inhibitor in a Phase 1b multi-dose study in hospitalized clinical trial participants with COVID-19.

“Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic,” commented Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer, and President, Worldwide Research, Development and Medical of Pfizer, in a press release.

“We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients."

"Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.”

Protease inhibitors bind to a viral enzyme, preventing the virus from replicating in the cell. Protease inhibitors have effectively treated other viral pathogens such as HIV and hepatitis C virus, both alone and in combination with other antivirals.

To learn more, visit New York-based Pfizer on www.Pfizer.com.

Apr 8, 2021 • 3:21 pm CDT

Australian researchers published a study in BMC Infectious Diseases on April 7, 2021, that found antibiotics were initiated less frequently, and antivirals (oseltamivir) used more frequently in patients diagnosed with influenza using rapid polymerase chain reaction (RPCR) tests compared with standard multiplex PCR (MPCR) tests.

This retrospective cohort study of positive influenza RPCR and MPCR patients was performed utilizing data from the 2017 influenza season. Overall, 122 RPCR and 362 MPCR positive influenza patients were included in this study.

Commencement of antibiotics was less frequent in the RPCR than MPCR cohorts (51% vs. 67%).

People at high risk of complications from influenza who were tested with the RPCR were more likely to be treated with oseltamivir compared to those tested with the MPCR (76% vs. 63%; p = 0.03, OR 1.81; 95% CI 1.07–3.08).

Subgroup analyses of higher-risk patients for complications of influenza would suggest that RPCR testing leads to fewer missed opportunities for oseltamivir treatment than MPCR testing (24% vs. 37%, respectively).

Early oseltamivir use has benefits in improving clinical symptoms, reducing the risk of lower respiratory tract infections, and preventing hospital admission when used in influenza-positive patients.

In summary, these researchers stated, 'The use of a rapid influenza PCR test was associated with reduced inappropriate antibiotic use and increased appropriate oseltamivir use in patients at high risk of influenza complications.'

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Apr 8, 2021 • 11:09 am CDT

Indianapolis-based Eli Lilly and Incyte announced COV-BARRIER results, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC, on April 8, 2021. 

The clinical trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28.

Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).

Baricitinib has not been approved for the treatment of COVID-19 but has been authorized for emergency use by the U.S. FDA

"Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies," commented Ilya Yuffa, SVP, and president of Lilly Bio-Medicines, in a related press release.

"Even though the study did not show a statistically significant benefit on the primary endpoint, this trial showed the largest effect reported to date for the reduction in mortality observed for this patient population with COVID-19."

"As there remains an urgent need to reduce COVID-related deaths in hospitalized patients, we hope these results will provide further understanding and support for baricitinib's potential role in treatment on top of the current standard of care."

Lilly stated it intends to publish detailed results of this study in a peer-reviewed journal in the coming months. Lilly will share the data from COV-BARRIER with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib for the treatment of hospitalized COVID-19 patients.

Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active rheumatoid arthritis (RA) and in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Baricitinib is authorized for use under an Emergency Use Authorization combined with remdesivir to treat suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Delaware-based Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development, and commercialization of proprietary therapeutics. 

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Apr 7, 2021 • 10:57 am CDT

The European Medicines Agency (EMA) announced today its safety committee (PRAC) concluded 'that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

Furthermore, the 'EMA confirmed the overall benefit-risk of Vaxzevira vaccination remains positive.'

In reaching its conclusion on April 7, 2021, the PRAC considered all currently available evidence, including the advice from an ad hoc expert group.

The EMA reminds healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

People who have received the Vaxzevria vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.

According to the EMA, one plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one sometimes seen in patients treated with heparin (heparin-induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and take any further actions.

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Apr 7, 2021 • 10:36 am CDT

The JAMA Network Open published a human papillomavirus (HPV) vaccine study on April 5, 2021, that found women who received the 9-valent human papillomavirus (9vHPV) vaccine during early pregnancy did not experience an increase in miscarriages or adverse birth outcomes.

And among live births, 9vHPV vaccine exposures during or around the time of pregnancy were not associated with adverse birth outcomes.

This cohort study analyzed data from seven participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included.

The data used included more than 800 live births with during-pregnancy or peripregnancy 9vHPV vaccine exposures and nearly 700 live births with follow-up to evaluate for congenital disabilities.

These researchers concluded by saying, 'This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with spontaneous abortions or selected adverse birth outcomes.'

'Given the continual need for catch-up 9vHPV vaccination in women up to age 26 years, along with the expanded use of 9vHPV vaccination in women up to age 45 years, the findings from this study can inform counseling after inadvertent 9vHPV vaccine exposures during or around the time of pregnancy.' Note: This study's sample size was limited.

A list of approved HPV vaccines is rendered on this webpage.

This study was funded by a contract (200-2012-53526-0006) with the CDC. Dr. Sheth was supported in part by K07CA230234 from the National Cancer Institute of the National Institutes of Health. No industry conflicts of interest were disclosed.

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Apr 6, 2021 • 3:49 pm CDT

Public-health officials must strike a “delicate balance” when communicating risks of side effects following vaccination. An adverse event would be directly linked to a vaccine using a specific lab test in ideal situations.

But these kinds of tests aren’t possible for most adverse events, either because there aren’t specific biomarkers to test for or because such tests are impractical, reported the journal Nature on April 1, 2021.

At least initially, the events are only linked by their timing: a person receives a vaccine and then experiences the side effect at some point afterward. This makes it particularly challenging to prove whether the vaccine actually caused the adverse event.

To address this issue, the US government launched in 1990 the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. 

An important note from the U.S. HHS says, 'If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. The U.S. CDC and FDA do not provide individual medical treatment, advice, or diagnosis. If you need individual medical or health care advice, consult a qualified healthcare provider.'

Apr 6, 2021 • 10:53 am CDT

France-based Valneva SE announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this new data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

In the VLA2001-201 study, three dose levels of VLA2001 (low, medium, high), based on a schedule of two doses with vaccinations three weeks apart, were evaluated in 153 healthy adults aged 18 to 55 years.

VLA2001 was generally safe, and well-tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board. There were no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity.

The majority of Adverse Events (AEs) were mild or moderate, and only two subjects reported severe solicited AEs (headache and fatigue). All solicited AEs were transient. Only 17.6% of unsolicited AEs up to day 36 were considered related to the vaccine, and no severe unsolicited AEs were reported. No serious related AEs were reported.

VLA2001 was highly immunogenic, with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. Seroconversion Rates (SCR) for S-protein binding IgG antibodies were 89.8% in the medium-dose and 100% in the high-dose group.

Two weeks after completing the two-dose schedule, the Geometric Mean Fold Rise (GMFR) from baseline was 26 in the medium-dose and 86 in the high dose group.

Of note, the IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay (MNA50) (r=0.79, p<0.001).

VLA2001 induced a dose-dependent response with statistically significant higher Geometric Mean Titres (GMTs) for both IgG and neutralizing antibodies in the high dose group compared to the low and medium dose groups. In the high dose group, the GMT of neutralizing antibody titers measured two weeks after completion of the two-dose schedule was at or above levels for a panel of convalescent sera (GMT 530.4 (95% CI: 421.49, 667.52)).

With a GMT ratio of vaccine vs. convalescent sera ≥ 1, vaccine efficacy has been reported above 80% for other vaccines.

VLA2001 induced broad T-cell responses across participants with antigen-specific IFN-gamma producing T-cells against the S-protein, M, and N protein detected in 75.6 %, 35.6%, and 48.9% of study participants, respectively.

Thomas Lingelbach, CEO of Valneva, commented in a press release, “We are extremely pleased with these results, which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19. The world needs multiple vaccines as well as booster options."

"Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process."

Saint-Herblain-based Valneva is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19, and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers.

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Apr 5, 2021 • 9:02 am CDT

California-based Vir Biotechnology, Inc. announced new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 virus monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor-binding domain (RBD) of SARS-CoV-2, called L452R.

L452R has been found in the California SARS-CoV-2 variant (B.1.427/B.1.429).

Study results also demonstrate that the L452R mutation reduced the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs.

Non-peer-reviewed data was published on April 1, 2021, and submitted to a peer-reviewed journal for future print publication.

In this new study, researchers at Vir and the University of Washington report the rapid and exponentially increasing spread of the California variant throughout all 50 states and in 29 additional countries worldwide and characterize the impact of its three mutations: S13I and W152C in the NTD and L452R in the RBD.

Data from 43 vaccinated donors and nine convalescent donors demonstrated that, in a pseudotyped virus system, the S13I, W152C, and L452R mutations reduced the neutralization potency of plasma by three to sixfold.

The L452R mutation reduced the neutralization activity of 14 out of 35 RBD-specific mAbs, including three clinical-stage antibodies. Researchers also observed a complete loss of neutralization by all NTD-specific mAbs mediated by an unconventional escape mechanism. VIR-7831, which targets a non-receptor binding motif (RBM) epitope, was unaffected by the L452R mutation.

“The rapid increase in the frequency of this variant in California and neighboring states and its ability to confer some degree of resistance to vaccines and antibody therapies is concerning,” commented David Veesler, Ph.D., associate professor of biochemistry, the University of Washington in Seattle, in a press statement.

“The reduced sensitivity of this variant to plasma antibodies results from three individual spike mutations that mediate evasion from both RBD (partial) and NTD (total) specific antibodies. Together, these data demonstrate that if we are to combat current and anticipated future variants, there is a critical need for monoclonal antibodies that target invariant regions of the spike protein with the potential for a high barrier to resistance.”

VIR-7831 is an investigational compound not approved by the U.S. Food and Drug Administration or any other regulatory authority.

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

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Apr 4, 2021 • 10:45 am CDT

The NYT reported at the direction of the US Department of Health and Human Services, Johnson & Johnson (J&J) will take charge of Emergent BioSolution's Baltimore product plant that ruined 15 million doses of its Janssen COVID-19 vaccine, senior federal health officials confirmed on April 3, 2021.

New Jersey-based J&J confirmed this news to the Washington Post.

News reports indicate workers at the Emergent plant mixed up ingredients of two experimental COVID-19 vaccines, J&J's Janssen and AstraZeneca. The production error was detected, and none of the contaminated vaccine doses were distributed.

On March 31, 2021, J&J released the following statement:

'Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities, and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.

We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.

As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.

This quality control process identified one batch of drug substances that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substances for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.

This is an example of the rigorous quality control applied to each batch of a drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration.'

And on April 1, 2021, Gaithersburg, MD-based Emergent released the following statement:

'Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, there are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch, and it will be disposed of properly.

Importantly, the quality control systems worked as designed to detect and isolate this single batch. 

Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.

We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic.'