Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Dec 8, 2021 • 7:03 am CST

New York-based Pfizer Inc. and its vaccine development partner BioNTech SE today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Comirnaty Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses.

Sera obtained from vaccinees one month after receiving a third Comirnaty vaccine dose neutralized the Omicron variant to levels comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

The companies stated the 'Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type."

"This (data) indicates that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant.'

'However, as the vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron.'

And the companies believe that vaccinated individuals may still be protected against severe forms of the disease.

According to the companies' preliminary internal data, a third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes, which are considered to correlate with the protection against severe disease.

Compared to the wild-type virus, most of these epitopes remain unchanged in the Omicron spike variant.

Known globally as Comirnaty, the vaccine is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen. 

"Our preliminary, first dataset indicates that a third dose could still offer a sufficient level of protection from (COVID-19) of any severity caused by the Omicron variant," said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, in a press release issued on December 8, 2021. 

"We continue to work on an adapted vaccine which, we believe, will help to induce a high level of protection against Omicron-induced COVID-19, as well as a prolonged protection compared to the current vaccine."

On November 25, 2021, the companies started to develop an Omicron-specific COVID-19 vaccine.

While these results are preliminary, the companies stated they would continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron and inform the most effective path forward.

The Comirnaty vaccine was issued the first U.S. FDA and WHO authorization to prevent severe COVID-19 in late 2020. 

Dec 8, 2021 • 6:13 am CST

A global leader in vaccine production told CNBC-TV18 today,  it may reduce COVID-19 vaccine production due to lack of demand, reported the BBC.

"I am in a dilemma which I never imagined," stated Mr. Adar Poonawalla, Serum Institute of India Pvt. Ltd.'s CEO.

"We have no other orders at hand. So I am going to be reducing the production (CoviShield) by at least 50%, to begin with, monthly until orders again pick up either in India and the world."

"Also, India has vaccinated about 83 million of the roughly 130 million adults above 60 years so far. However, we still have a gap in terms of vaccine coverage among our most vulnerable people," he said.

And, future Covishield demand may come from the Indian government, which has not confirmed its booster vaccination program.

CoviShield is made from a virus (ChAdOx1), a weakened version of a common cold virus. In addition, genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein.

This COVID-19 vaccine was co-developed by AstraZeneca Plc and the University of Oxford and is the same formulation as the Vaxzevria (AZD1222) vaccine.

On March 19, 2021, the WHO confirmed that the AstraZeneca COVID-19 vaccine (Covishield) has a favorable benefit-risk profile, with tremendous potential to prevent infections and reduce deaths worldwide.

Based in Prune, Serum Institute of India is ranked as India's No. 1 biotechnology company, manufacturing highly specialized life-saving biologicals like vaccines using cutting-edge genetic and cell-based technologies, antisera, and other medical specialties.

Dec 8, 2021 • 5:33 am CST

France-based Valneva SE today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the inactivated COVID-19 vaccine candidate VLA2001.

And, Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority. Subject to approval, the Company is forecasting vaccine deliveries in the first quarter of 2022.

This announcement is the second purchase agreement Valneva has secured since reporting positive data for its Phase 3 clinical trial Cov-Compare last month.

In October 2021, the European Commission signed an advanced purchase agreement with Valneva for up to 60 million doses of VLA2001.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, including addressing new variants. 

A Bahraini government spokesperson stated, “Subject to approval, Bahraini citizens and residents will have the ability to choose from a variety of vaccines in Bahrain that will have a positive impact on driving up vaccinations rates with 93% of the eligible population now fully vaccinated in the Kingdom.”

Bahrain is a country of about a 1.7million people located in the Persian Gulf. The island nation comprises 50 natural islands and an additional 33 artificial islands, centered on Bahrain Island.

Valneva is a specialty vaccine company located in Saint-Herblain, France, focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. 

Dec 7, 2021 • 4:16 pm CST

New Jersey-based Seqirus today announced new real-world evidence supporting the relative effectiveness of FLUAD®, its adjuvanted trivalent vaccine (aTIV), compared with standard-dose, non-adjuvanted trivalent influenza vaccine and standard-dose quadrivalent influenza vaccine in reducing influenza-related outcomes in Italy.

Over 18 flu seasons, this study demonstrated that aTIV was associated with a 12% lower risk of hospitalization and a 37% lower risk of respiratory-related hospitalizations compared with the other vaccines.

"Age-related immune decline can make it harder for the body to mount a sufficient immune response to flu vaccination in people aged 65 and older, who currently account for an estimated 727 million people globally – a number expected to double by 2050," commented Gregg Sylvester, M.D., Chief Medical Officer, Seqirus, in a press release.

Additionally, two studies demonstrated the cost-effectiveness of FLUAD® QUADRIVALENT, its adjuvanted quadrivalent seasonal influenza vaccine (aQIV) in Spain and France.

"In Spain alone, nearly 20% of the population is aged 65 and older as of 2020, and this percentage can be expected to grow in the coming years," said Sergio Marquez-Pelaez, Pablo de Olavide University, Seville, and study-co-author. 

"The use of enhanced seasonal influenza vaccines, such as those that utilize an adjuvant, not only help to reduce influenza-related outpatient visits and hospitalizations in this population but may also reduce the economic and societal burden associated with increased outpatient medical encounters."

Researchers also presented a budget impact model analysis in France that concluded utilizing aQIV in place of QIVe over three years may result in increased vaccination costs of about €90.7M.

However, this investment could yield savings totaling €66.3M from fewer influenza events and complications driven by avoidance of medical care visit costs, outpatient complication costs, and inpatient complication costs.

These findings are similar to the published models in the U.K. and Italy, evaluating the cost-effectiveness of adjuvanted quadrivalent influenza vaccine.

The World Health Organization (WHO) estimates that seasonal influenza may result in nearly 290,000 to 650,000 respiratory deaths each year.

The WHO recommends annual vaccination as the most effective way to prevent influenza, especially for people at a higher risk of influenza complications, such as individuals over 65 years of age.

These data were presented at the European Scientific Working Group on Influenza 8th Virtual Conference held from December 4-7, 2021. 

Note: Economic evaluations in health can be an instrumental complement to the decision-making process, and the methodological approaches should be continually refined and improved.

Seqirus, based in Summit, NJ, is part of CSL Limited, one of the largest influenza vaccine providers in the world.

Dec 7, 2021 • 2:39 pm CST

The Texas Department of State Health Services (DSHS) announced today it is launching a new COVID-19 therapeutic infusion center in El Paso. This innovative treatment is available at no cost to the patient.

COVID-19 antibody infusion treatment can prevent a patient's condition from worsening and requiring hospital care.

The El Paso infusion center will begin accepting patients today and has been provided with the REGEN-COV monoclonal antibodies to treat outpatient cases of COVID-19 who have a referral from a doctor.

Regeneron's REGEN-COV Anti-SARS-CoV-2 Monoclonal Antibody treatment combines two monoclonal antibodies, casirivimab, and imdevimab, explicitly designed to block the infectivity of the SARS-CoV-2 betacoronavirus that causes COVID-19.

Texas Governor Abbott stated in a media statement, "I thank DSHS for continuing to work alongside local partners in communities across the state to establish these facilities where they are needed most." 

Texas began deploying similar measures in November 2020.

DSHS and other departments have established and expanded these facilities to increase bed capacity in local hospitals so that resources are available for the illest patients.
 
These state-sponsored Infusion Centers are in addition to the antibody infusion treatments provided by more than 200 private health providers across the state. 

Texans can visit meds.tdem.texas.gov to find a therapeutic provider near them.

Dec 7, 2021 • 1:14 pm CST

Basel-based Roche announced that the European Commission (EC) had extended the marketing authorization for Actemra® / RoActemra® today to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Following the recent emergence of the new SARS-CoV-2 variant of concern, Omicron (B.1.1.529), the World Health Organization (WHO) has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.

"Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, in a press statement.

"The totality of evidence shows that Actemra/RoActemra can benefit those suffering from severe COVID-19."

The decision from the EC today follows an accelerated assessment by the EMA's CHMP, which reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.

Outside of the European Union, Actemra/RoActemra has been provisionally approved in Australia, authorized for emergency use in the U.S. and Ghana, and recommended by the World Health Organization to treat COVID-19.

Roche is working closely with regulatory bodies and other partners worldwide on the next steps to bring this medicine to as many people as possible.

Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide. It was the first approved anti-IL-6 receptor biologic and is available in intravenous and subcutaneous formulations to treat adult patients with moderate-to-severe active rheumatoid arthritis.

In 2020, Roche entered into several new partnerships, including Regeneron (REGEN-CoV) and Gilead, to develop, manufacture, and distribute molecules that can potentially treat and prevent COVID-19.

The Roche Group, headquartered in Basel, Switzerland, was founded in 1896 and is active in over 100 countries and employed more than 100,000 people worldwide in 2020.

Dec 7, 2021 • 9:38 am CST

England-based Medicago and GlaxoSmithKline (GSK) today announced positive results from the global Phase 3 placebo-controlled efficacy study of Medicago's plant-based COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, conducted across six countries.

The overall vaccine efficacy rate against all variants of SARS-COV-2 was 71%. And the Omicron variant was not circulating during this study.

Medicago will imminently seek regulatory approval from Health Canada as part of its rolling submission based on these results.

However, the vaccine candidate is not approved yet by any regulatory authorities.

Thomas Breuer, GSK's global COVID-19 adjuvanted vaccines lead and Chief Global Health Officer, said in a press release, "These are encouraging results given data were obtained in an environment with no ancestral virus circulating."

"The global COVID-19 pandemic is continuing to show new facets with the current dominance of the Delta variant, upcoming Omicron and other variants likely to follow."

"The combination of GSK's established pandemic adjuvant with Medicago's plant-based vaccine technology has significant potential to be an effective, refrigerator-stable option to help protect people against SARS-CoV-2."

Medicago has been developing its plant-based technology for the past 20 years, using unique technology to produce Virus-Like Particles (VLP) for its protein vaccines.

VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognized by the immune system. In addition, because the VLPs lack core genetic material, they are non-infectious and unable to replicate.

Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation. For more information: www.medicago.com

Dec 7, 2021 • 5:34 am CST

California-based Vir Biotechnology, Inc. and GlaxoSmithKline plc today announced an update to non-peer-reviewed preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the known Omicron spike protein, the new SARS-CoV-2 variant (B.1.1.529).

The preclinical data was generated through pseudo-virus testing of the combined known mutations of the Omicron variant, which included the maximum number of changes (37 mutations) identified to date in the spike protein.

Additionally, Vir Bio announced that management would host a conference call at 8:30 am ET, December 7, 2021, to discuss the new data.

A live webcast can be accessed under Events & Presentations in the Investors section of the Vir website at www.vir.bio.

George Scangos, Ph.D., CEO of Vir, said in a press release, "Sotrovimab is the first monoclonal antibody to report preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the still prevalent and highly contagious Delta variant."

"Given the less than three-fold neutralization shift demonstrated in the preclinical pseudo-virus assay, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19."

Sotrovimab (Xevudy®) is a pan-sarbecovirus anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the betacoronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.

Sotrovimab is authorized for emergency use in the United States. 

Xevudy (sotrovimab) received a positive scientific opinion in the EU, conditional marketing authorization in the UK, Australia, Saudi Arabia, and has been approved via the Special Approval for Emergency Pathway in Japan.

And temporary authorizations for sotrovimab have been granted in a dozen countries.

Dec 7, 2021 • 5:03 am CST

When the genome of the SARS-CoV-2 Omicron variant (B.1.1.529) was released on November 22, 2021, it caused significant media attention due to the large number of mutations it contains.

These raw data have spurred questions around COVID-19 vaccines and antibody therapy efficacy.

Given that neither the structural information nor the experimentally-derived antibody interaction of this variant are available, researchers turned to predictive computational methods to model the mutated structure of the spike protein's receptor-binding domain and posit potential changes to vaccine efficacy.

In this non-peer-reviewed study published by bioRxiv on December 6, 2021, these researchers predict some structural changes in the receptor-binding domain that may reduce antibody interaction, but no drastic changes that would completely evade existing neutralizing antibodies, and therefore current COVID-19 vaccines.

'While in vitro experiments are needed to validate these predictions, the predicted results here suggest that existing neutralizing antibodies will still bind to the mutated spike protein of the Omicron variant.'

'However, it appears that the affinity of Omicrons's RBD for neutralizing antibodies is reduced compared to the reference RBD structures.'

'Though there are a multitude of mutations in the RBD of Omicron, these mutations do not appear to be causing any large conformational change that would totally evade antibody interaction.'

'Given the public health urgency in understanding the impacts of new SARS-CoV-2 variants requires that we act quicker than is possible in a lab.'

'Thus, in silico predictive tools like AlphaFold2 and HADDOCK are important for quickly understanding the biochemistry of variants and can help us infer the epidemiological implications of the variant.'

Dec 7, 2021 • 4:31 am CST

The U.S. CDC's reported late on December 6, 2021, sixty percent of people 5 years of age and older are now fully-vaccinated in the U.S.

This data indicates about 199 million people are better protected against severe COVID-19!

For surveillance purposes, COVID Data Tracker counts people as being "fully vaccinated" if they received two doses on different days of the two-dose mRNA series or received one dose of a single-dose COVID-19 vaccine, such as the Janssen (J&J) vaccine.

'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 and have received an additional dose.'

'If you are fully vaccinated and become infected with the SARS-CoV-2 Delta or Omicron variant, you can spread the virus to others.'

It would be best if you continued to take all precautions recommended for unvaccinated people until advised otherwise by your healthcare provider,' says the CDC.

Also, on December 6, 2021, the European Centre for Disease Prevention and Control reported 66.4% of Europeans had been fully vaccinated.

In Europe, the European Medicines Agency has Authorized four COVID-19 vaccines and is reviewing five other vaccines. 

Globally, over 120 COVID-19 vaccine candidates are undergoing clinical trials reported GAVI.

 

 

Dec 6, 2021 • 3:42 pm CST

The Lancet recently published a study that found six different COVID-19 boosters were safe and provoked strong immune responses in people who have previously received a two-dose primary vaccination course.

The COV-BOOST study looked at safety, immune response (immunogenicity), and side-effects (reactogenicity) of vaccines when used as a third booster jab.

Increases in anti-spike protein antibody levels after 28 days varied across the vaccines.

And all booster results were similar for participants aged 30-69 years and those aged 70 years or older.

Reactions to all vaccines were similar, with fatigue, headache, and injection site pain most often reported.

"The side effect data show all seven vaccines are safe to use as 3rd doses, with acceptable levels of inflammatory side effects like injection site pain, muscle soreness, fatigue. While all boosted spike protein immunogenicity after two doses of AstraZeneca, only AstraZeneca, Pfizer-BioNTech, Moderna, Novavax, Janssen, and Curevac did so after two doses of Pfizer-BioNTech", commented Professor Saul Faust on December 2, 2021, trial lead and Director of the NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust.

"It's encouraging that a wide range of vaccines, using different technologies, show benefits as a third dose."

"That gives confidence and flexibility in developing booster programs here in the UK and globally."

"It's important to note that these results relate only to these vaccines as boosters to the two primary vaccinations and to the immune response they drive at 28 days."

"Further work will generate data at three months and one year after people have received their boosters, which will provide insights into their impact on long-term protection and immunological memory."

"We are also studying two of the vaccines in people who had a later third dose after 7-8 months, although results will not be available until the new year," adds Professor Faust.

The authors warn that the boost ratios should be interpreted with caution because they relate to immunogenicity rather than protection against disease, and the relationship between antibody levels at day 28 and long-term protection and immunological memory is unknown.

The study has several limitations, such as due to pandemic timelines and the need to generate data to inform policy in September 2021, the interval between second and third doses was shorter in some participants than between their first two doses.

This study was funded by the UK Vaccine Taskforce and National Institute for Health Research. 

Dec 6, 2021 • 12:23 pm CST

The European Medicines Agency (EMA) human medicines committee announced it has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic therapy with corticosteroids and require supplemental oxygen or mechanical ventilation.

In reaching its conclusion, the EMA committee evaluated data from a study involving 4,116 hospitalized adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood (indicating inflammation). 

The study showed that treatment with RoActemra given by infusion in addition to standard treatment reduces the risk of death when compared with standard treatment alone.

Overall, 31% of patients treated with RoActemra plus standard treatment died within 28 days of treatment compared with 35% of patients receiving standard therapy alone.

In addition, 57% of patients (1,150 out of 2,022) who received RoActemra were able to leave the hospital within 28 days compared with 50% of patients (1,044 out of 2,094) who received standard treatment alone.

RoActemra, marketed by Roche Registration GmbH, is already approved in Europe for treating the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, and cytokine release syndrome.

RoActemra is an immunomodulating medicine that changes the immune system's activity.

The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein designed to attach to a specific target (called an antigen) in the body.

RoActemra attaches to the receptor for a messenger molecule or 'cytokine' called interleukin-6 (IL-6), produced by the body's immune system in response to systemic inflammation, which plays an important role in severe COVID-19 disease and associated respiratory failure.

By preventing IL-6 from attaching to its receptors, RoActemra reduces the inflammation and improves symptoms of severe COVID-19.

In the U.S., the FDA issued an Emergency Use Authorization for the use of ACTEMRA to treat COVID-19 in adult and pediatric patients (2 yrs+) who are in the hospital and who are receiving corticosteroids and require supplemental oxygen, or a machine that helps with their breathing, or a machine that adds oxygen to the blood outside the body (ECMO).

ACTEMRA is not FDA-Approved to treat COVID-19.

Dec 6, 2021 • 12:03 pm CST

Pennsylvania-based NRx Pharmaceuticals was advised today that the independent Data Safety Monitoring Board overseeing the phase 2 trial of the BriLife™ vaccine candidate has concluded its safety analysis, with a formal report expected in the coming days.

Based on the input received, NRx is proceeding with its plans to initiate a phase 2b/3 registration trial of BriLife.

The BriLife 002 phase 2b/3 trial is expected to commence in Israel and the Nation of Georgia, with European and North American countries to be added once the initial phase 2b volunteers have been vaccinated. 

In contrast to first-generation vaccines against COVID, BriLife is a viral vector vaccine that presents the entire spike protein complex of the coronavirus to the body’s immune system and is able to present multiple variants of the spike protein simultaneously.

Laboratory studies of antibody response to the SARS-CoV-2 virus variant Omicron are underway.

NRx believes this will potentially equip BriLife to create a more robust immune response than vaccines that present only a single variant of the spike protein or even a portion of a single variant to the immune system.

Unlike other vaccines, BriLife binds to the specific cells in the lung and nasal cavity targeted by the SARS-CoV-2 coronavirus.

This finding creates a potential for the vaccine to generate a level of tissue immunity that may prevent vaccinated individuals from contracting and spreading new variants of COVID, even if they do not personally contract the virus.

And the binding of BriLife to cells that line the respiratory tract similarly opens the possibility of delivering the vaccine as a nasal spray.

“We are excited to move forward with a multi-nation trial of BriLife at a time when the immunity that has been built through widespread adoption of first-generation vaccines is increasingly challenged by new variants,” said Prof. Jonathan Javitt, M.D., MPH, Chairman, and CEO of NRx Pharmaceuticals, in a press statement.

In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife vaccine developed by the Israel Institute for Biological Research.

Dec 6, 2021 • 10:09 am CST

New Jersey-based Johnson & Johnson (J&J) announced on December 5, 2021, preliminary results from an independent, non-peer-reviewed study, including a subset of participants from the Janssen-sponsored COV2008 study, which showed that a booster dose of the Janssen COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of the Comirnaty (BNT162b2) vaccine, increased both antibody and T-cell responses.

These results demonstrate the potential benefits of heterologous boosting (mix-and-match), stated J&J.

"These results provide valuable scientific insights for our vaccine when used as a mix-and-match booster and can help inform boosting strategies with the goal to curb the pandemic," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, J&J, in a press release.

These Phase 2 data are reinforced by preliminary results from the UK COV-BOOST clinical study published in The Lancet, which demonstrated that following primary vaccination with two doses of either Comirnaty (BNT162b2) (n=106) or ChAdOx1 nCov-19 (n=108), a booster dose of the Janssen COVID-19 vaccine increased both antibody and T-cell responses.

The U.S. CDC Advisory Committee on Immunization Practices has recommended the Janssen COVID-19 vaccine as a booster for all eligible individuals aged 18 years and older who receive an authorized COVID-19 vaccine.

And in collaboration with academic groups in South Africa and around the world, J&J has been evaluating the effectiveness of its COVID-19 vaccine across variants, now including the Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as needed.

The new study was conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center.

Dec 4, 2021 • 8:33 am CST

The U.S. Food and Drug Administration (FDA) announced it revised the existing emergency use authorization (EUA) of bamlanivimab and etesevimab to additionally authorize the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns.

The revised EUA was issued to Indiana-based Eli Lilly Co. on December 3, 2021, and includes those who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

This revision also authorizes bamlanivimab and etesevimab to be administered together for post-exposure prophylaxis to prevent COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death. 

In February 2021, the FDA originally authorized bamlanivimab and etesevimab administered together to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg). 

And on September 16, 2021, the FDA authorized its use for the post-exposure prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high-risk for progression to severe COVID-19, including hospitalization or death.

In support of the FDA's new action, bamlanivimab and etesevimab administered together were studied in a clinical trial of 125 pediatric patients (14 received placebo), all with at least one risk factor for severe COVID-19, to evaluate the safety and pharmacokinetics of treatment in pediatric patients.

Patients weighing less than 88 pounds received doses of bamlanivimab and etesevimab adjusted for their body weight to achieve comparable exposures to adults and adolescents receiving the authorized dose.

Given the similar course of COVID-19 disease, the authorization of bamlanivimab and etesevimab in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, together with additional pharmacokinetic and safety data from the clinical trial in pediatric patients. 

"Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention. Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19, and this authorization addresses the medical needs of this vulnerable population," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press release.

"While today's authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination."

"Vaccines remain our best tool in the fight against the virus, and there is a COVID-19 vaccine authorized for children five years of age and above," added Dr. Cavazzoni.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens, such as viruses.

Bamlanivimab and etesevimab are monoclonal antibodies directed explicitly against the spike protein of the SARS-CoV-2 virus, designed to block the virus' attachment and entry into human cells.

Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

Serious adverse events, including hypersensitivity, anaphylaxis, and infusion-related reactions, have been observed with bamlanivimab with and without coadministration of etesevimab.

Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash. 

Furthermore, the FDA confirmed it is working with sponsors of all currently authorized therapeutics to assess the activity against any SARS-CoV-2 coronavirus variant(s) of interest, such as Omicron, and is committed to communicating with the public as we learn more.

The FDA has authorized other anti-SARS-CoV-2 antibody treatments listed on this U.S. NIH web page.