Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jan 26, 2022 • 8:52 am CST

Pennsylvania-based NRx Pharmaceuticals today announced it had received a first safety report from a hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure.

These patients were treated with ZYESAMI at the first onset of respiratory failure after exhausting remdesivir and other approved therapies.

The safety report indicated that of the first 19 patients treated by Dec. 31, 2021, three had died, and 16 (84%) were reported to be alive by Jan. 22, 2021.

At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home, and two remained in the hospital.

This use of ZYESAMI occurred during the current Omicron variant surge, although these COVID-19 patients were not necessarily tested for the specific virus variant that caused their ICU admission.

These data were included in an application to the U.S. FDA for Emergency Use Authorization to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir (Veklury).

These patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who cannot participate in a clinical trial to access specific unapproved treatments.

This data does not involve a control group and are not part of a research study designed to test efficacy.

However, ZYESAMI continues to be tested in the ongoing NIH-sponsored ACTIV-3b (TESICO) clinical trial that has now accrued two-thirds of its targeted enrollment.

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970.

VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation, says NRx.

NRx Pharmaceuticals is located in Radnor, PA, and draws upon more than 300 years of collective, scientific, and drug-development experience to improve patients' health.

Jan 26, 2022 • 5:30 am CST

Researchers at the NYU Grossman School of Medicine led a recent study published in the JAMA Network Open on January 25, 2022 that found transfusions of blood plasma donated by people who have already recovered from infection with the pandemic coronavirus may help other patients hospitalized with COVID-19.

Notably, these researchers found that the most significant benefits for the therapy were among patients most at risk for severe complications because of pre-existing conditions, such as diabetes or heart disease.

The study showed that among 2,341 patients, those who received an injection of convalescent plasma soon after hospitalization were 15% less likely to die from COVID-19 within one month.

However, this meta-analysis found no association of COVID-19 Convalescent Plasma (CCP) with better clinical outcomes for the typical patient. 

CCP contains antibodies are blood proteins that are part of the immune system.

Shaped so they can attach to the SARS-COV-2 virus, these antibodies glom onto and tag it for removal from the body, researchers say.

The transfusion treatment, which contains antibodies and other immune cells needed to fight the infection, also appears to benefit those with type A or A.B. blood.

"Our results show that, overall, patients hospitalized with COVID-19 may derive modest benefit from convalescent plasma, with some patient subgroups benefiting more than others," commented study lead investigator and biostatistician Andrea Troxel, ScD, in a press release. 

Convalescent plasma treatments are considered experimental by the U.S. Food and Drug Administration (FDA).

Concerning the groups most likely to benefit, the FDA revised the Emergency Use Authorization for convalescent plasma on December 28, 2021, limiting its use to patients with diseases that suppress their immune systems or that receive medical treatments with the same effect.

These findings suggest that real-time individual patient data pooling and meta-analysis during a pandemic are feasible, offering a model for future research and providing a rich data resource.

Study co-investigator Eva Petkova, Ph.D., says the team uses its study data to create a scoring system of patient descriptors, including age, stage of COVID-19, and co-existing diseases, making it easier for clinicians to calculate who stands to benefit most from the use of convalescent plasma.

The index is freely available online at [].

Jan 25, 2022 • 10:36 am CST

Japan-based Chugai Pharmaceutical Co., Ltd. announced on January 21, 2022, that it obtained regulatory approval from the Ministry of Health, Labour, and Welfare for the Actemra® humanized anti-human IL-6 receptor monoclonal antibody (mAbs).

Actemra has already obtained regulatory approval for various indications in more than 110 countries.

Japan's approval came one month after the application for the additional indication of Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia, limited to patients requiring oxygen intervention.

"Clinical studies demonstrated that Actemra reduced the mortality rate in patients with SARS-CoV-2 infection," Chugai's President and CEO, Dr. Osamu Okuda, commented in a related press statement.

"We hope that Actemra will play a role for the better prognosis of patients with severe, potentially life-threatening pneumonia."

This COVID-19 treatment approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study), three placebo-controlled, randomized, double-blind, multicenter, global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study), and a single-arm, multicenter phase III study in Japan (J-COVACTA study).

Actemra has been approved in the European Union, authorized for emergency use in the United States, and recommended by the World Health Organization to treat COVID-19.

Actemra is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for six indications in Japan: Castleman's disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, and adult Still's disease.

In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, giant cell arteritis.

Jan 25, 2022 • 8:19 am CST

New York-based Pfizer Inc. and BioNTech SE today announced the initiation of a clinical study to evaluate an Omicron-based vaccine candidate. The new study is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

The study will include about 1,400 healthy adults 18 through 55 years of age and have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine.

Participants enrolled in this clinical trial will receive the Omicron-based vaccine candidate as a two-dose primary series and as a booster dose.

".... we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future," commented Kathrin U. Jansen, Ph.D., SVP and Head of Vaccine Research & Development at Pfizer, in a press statement issued on January 25, 2022. 

"Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection."

"We believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal."

The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. This capacity is not expected to change if an adapted vaccine is required.

Globally, this vaccine is known as Comirnaty.

The Pfizer-BioNTech / Comirnaty Vaccine is based on BioNTech's proprietary mRNA technology, which BioNTech and Pfizer developed.

BioNTech is the Comrinaty vaccine Marketing Authorization Holder in the U.S., E.U, U.K, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the U.S. (jointly with Pfizer) and other countries. 

Medical Review by
Jan 25, 2022 • 7:21 am CST

A clinical trial funded by the U.S. National Institutes of Health (NIH) and published in the journal The Lancet on January 22, 2022, found that giving peanut oral immunotherapy to highly peanut-allergic children safely desensitized most of them to peanut and induced remission of peanut allergy in 20%.

The immunotherapy consisted of a daily oral dose of peanut flour for 2.5 years.

In this phase 2 study, remission was defined as eating 5 grams of peanut protein, equivalent to 1.5 tablespoons of peanut butter, without having an allergic reaction six months after completing immunotherapy.

The youngest children (1 to 3 years) and those who started the trial with lower levels of peanut-specific antibodies were most likely to achieve remission.

Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, part of the NIH, stated in a related press release, “It is our hope that these study findings will inform the development of treatment modalities that reduce the burden of peanut allergy in children.”

Peanut allergy affects about 2% of children in the U.S., or nearly 1.5 million individuals ages 17 years and younger.

The risk of a life-threatening allergic reaction to accidentally eaten peanuts is significant for these children, most of whom remain peanut-allergic for life.

The trial results, called IMPACT, are available at this NIH link.

Medical Review by
Jan 25, 2022 • 5:12 am CST

Based in the U.K., the world's most extensive clinical study investigating potential COVID-19 treatments announced on January 24, 2022, testing Merck's oral antiviral treatment molnupiravir will begin with about 46,500 participants.

Whilst it has already been approved in the U.K. for treating people in the community with mild COVID-19 who are at high risk of developing the severe disease, for instance, cancer patients, it is unknown whether molnupiravir can also benefit patients who have been hospitalized because of COVID-19.

The study is open to all patients hospitalized with severe COVID-19 and in 177 NHS hospital sites across the U.K.

The RECOVERY Trial was initially launched as emergency response in March 2020 and has discovered three effective treatments for COVID-19: the inexpensive steroid dexamethasone; the arthritis drug tocilizumab; and a monoclonal antibody treatment, now known as Ronapreve (REGEN-COV).

However, as the emergence of the Omicron variant demonstrates, it remains essential to investigate new potential treatments.

Molnupiravir, a tablet treatment initially developed for influenza, causes errors to accumulate in the genetic code of the SARS-CoV-2 coronavirus, preventing the virus from replicating.

The RECOVERY intends to compare molnupiravir (800 mg twice daily for five days) with the usual standard of hospital care in adult patients.

Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said in a press statement, "Throughout this pandemic, we have seen the important role that clinical trials play in assessing possible treatments for patients admitted to hospital with COVID-19."

"Because RECOVERY is now an established part of the routine care of NHS patients, the trial is well placed to recruit participants whenever and wherever patients are hospitalized with this disease."

 Molnupiravir is also being investigated as an at-home treatment by the PANORAMIC Trial, led by Oxford University's Nuffield Department of Primary Care Health Sciences.

The RECOVERY Trial continues to investigate other treatments, including sotrovimab, an investigational monoclonal antibody.

Note: The U.S. FDA authorized molnupiravir for certain people in December 2021. Separately, a study published by peer-reviewed The NEJM on December 16, 2021, found early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19.

Medical Review by
Jan 24, 2022 • 7:01 pm CST

The U.S. Office of the Assistant Secretary for Preparedness and Response today confirmed it was distributing 127,236 monoclonal antibody (mAbs) treatments to U.S. states, territories, and agencies this week.

The specific local allocations are listed on this webpage.

This week's allocation is about 98,000 less than the 225,590​ doses distributed during the week of January 17, 2022.

Currently, there are four mAbs Authorized by the U.S. FDA to treat certain patients. However, only two mAbs are being distributed this week:

  • Evusheld = 74,976
  • Sotrovimab = 52,260

Regarding the effectiveness of these mAbs against SARS-CoV-2 betacoronavirus variants, the U.S. NIH OpenData Portal confirmed on January 24, 2022, positive in vitro therapeutic activity against the Omicron (B.1.1.529) variant. 

The NIH issued an update on January 19, 2022, addressing the fact that the Omicron variant of concern is now the dominant SARS-CoV-2 variant in the Department of Health and Human Services ten regions.

Furthermore, the NIH dashboard indicates Sotrovimab is the most effective mAbs against Omicron.

Vir Biotechnology and GSK's Sotrovimab (Xevudy®) is a pan-sarbecovirus anti-SARS-CoV-2, human neutralizing mAbs 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.

Medical Review by
Jan 24, 2022 • 5:09 pm CST

The World Health Organization (WHO) executive board met today in Geneva, where its director-general warned that 'global conditions remain ideal for new SARS-CoV-2 betacoronavirus variants to emerge.'

During his address on January 24, 2022, WHO Director-General Tedros Adhanom Ghebreyesus, Ph.D., said it's dangerous to assume that Omicron will be the last variant or that the world has reached the end game of the COVID-19 pandemic.

However, he said it's possible to end the acute phase of the pandemic in 2022 if countries use tools and strategies known to drive down cases, including vaccinations.

Tedros said that although a comprehensive approach is needed, he singled out 'bridging the vaccine access gap as a key step for ending the acute phase.'

Currently, 85% of Africa's population has not received a single COVID-19 dose.

"How can that be acceptable to any of us," stated Tedros.

"We simply cannot end the emergency phase of the pandemic unless we bridge this gap."

"And we are making progress."

Just a week ago, COVAX delivered its one billionth COVID-19 dose.

Currently, the WHO has Listed ten COVID-19 vaccines for use globally.

As of January 21, 2022, about 63.3% of the U.S. population had been fully vaccinated with an Approve/Authorized COVID-19 vaccine. And the European Centre for Disease Prevention and Control reported almost 70% of Europeans had been fully vaccinated.

Medical Review by
Jan 24, 2022 • 4:25 pm CST

The peer-reviewed journal The Lancet published a rotavirus vaccine study on January 20, 2022 that found neonatal administration of the RV3-BB vaccine has the potential to improve protection against rotavirus disease in children in a high-child mortality country in Africa.

This study concluded the RV3-BB with the P[6] genotype was well tolerated and immunogenic when co-administered with Expanded Programme on Immunisation vaccines in a neonatal or infant schedule.

And a lower titre (mid-titre) vaccine generated similar IgA seroconversion to the high-titre vaccine.

This new study builds on data from a phase 2b trial in Indonesian infants, where three doses of the RV3-BB vaccine administered in the neonatal schedule were associated with a 94% protective efficacy against severe rotavirus disease at 12 months and 75% at 18 months of age.

There are potential advantages for a neonatal administration schedule for a rotavirus vaccine, such as an opportunity to reduce vaccine costs.

Furthermore, a dose of an oral rotavirus vaccine at birth provides the earliest opportunity to stimulate the developing mucosal immune system to protect against subsequent exposure to wild-type rotavirus.

And the use of an asymptomatic human neonatal rotavirus strain that binds to specific receptors in the neonatal gut avoids the potential risk of vaccine-associated diarrhea or liver dysfunction.

In the U.S., the CDC says about 70% of children can be protected from rotavirus disease of any severity. Two rotavirus vaccines are currently licensed for infants in the United States:

  • RotaTeq® is given in three doses at ages 2 months, 4 months, and 6 months
  • Rotarix® is offered in two doses at ages 2 months and 4 months

This study was supported by the Bill & Melinda Gates Foundation and an Australian Tropical Medicine Commercialisation Grant.

In 1973, a team at Murdoch Children’s Research Institute (MCRI) led by Professor Ruth Bishop discovered rotavirus as a causative agent of severe dehydrating gastroenteritis. The MCRI holds the license for the RV3-BB vaccine.

A licensing agreement with Changchun Zhuoyi Biological was initiated in June 2019 to make, manufacture and sell RV3-BB.

Medical Review by
Jan 23, 2022 • 11:47 am CST

The European Medicines Agency (EMA) COVID-19 task force highlighted growing evidence on January 18, 2022, indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. 

The task force undertook a detailed review of several clinical studies involving around 65,000 pregnancies at different stages.

The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births, or adverse effects on unborn babies following mRNA COVID-19 vaccination.

The most common side effects of mRNA vaccines in pregnant women also match those in the overall vaccinated population. However, these side effects are usually mild or moderate and improve within a few days of vaccination.

Most of the information for this EMA review came from mRNA vaccines (Comirnaty and Spikevax).

Initial clinical trials do not generally include pregnant people. As a result, data on the use of vaccines, as any other medicines during pregnancy, are not usually available at the time of the authorization but are obtained afterward.

Furthermore, the review of real-world evidence suggests that the benefits of receiving mRNA COVID-19 vaccines during pregnancy outweigh any possible risks for expectant mothers and unborn babies.

The EMA confirmed the human medicines committee would consider the latest data from the manufacturers of mRNA COVID-19 vaccines during pregnancy to update the recommendations in the product information for the vaccines where applicable.

In addition to COVID-19 and influenza vaccinations, the U.S. CDC suggests women get the Tdap vaccine to protect their baby against whooping cough, which can have similar symptoms to COVID-19.

The CDC recommends all pregnant women receive a Tdap vaccine during each pregnancy.

In addition, everyone who is around the baby should be up to date with their whooping cough vaccine.

Medical Review by
Jan 23, 2022 • 4:27 am CST

The Wall Street Journal reported on January 22, 2022, GSK and Vir Biotechnology are increasing the output of their leading monoclonal antibody (mAbs), sotrovimab. In addition, the Journal stated a second plant is coming online to help meet the overwhelming COVID-19 patient demand.

And, Fierce Pharma reported the U.S. FDA cleared a Samsung Biologics site on December 30, 2021, as a second sotrovimab manufacturing facility to make.

As part of its growth plan in 2022, Samsung Biologics stated on January 12 it is planning a new facility, Plant 5, where it will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA pDNA, and viral vectors, all at a single site.

This site will be added to the mRNA vaccine drug substance manufacturing suite the company is currently adding to its existing facility in Songdo, South Korea, which is expected to be ready for operations in early 2022. 

GSK and Vir expect to manufacture about 2 million mAbs doses globally in the first half of 2022.

However, during the week of January 17, 2022, only 52,064​​ ​sotrovimab doses were distributed in the U.S.

On May 26, 2021, GlaxoSmithKline LLC received Emergency Use Authorization from the FDA. And Europe authorized Xevudy (Sotrovimab) on December 17, 2021.

Sotrovimab is a fully human anti-SARS-CoV-2 mAbs selected based on its potential to neutralize coronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.

As of January 23, 2022, the U.S. NIH's OpenData Portal indicates sotrovimab is very effective against the SARS-CoV-2 virus variant known as Omicron.


Medical Review by
Jan 22, 2022 • 11:32 am CST

The New York-based TB Alliance announced on January 20, 2022, that it had received funding up to $30 million over five years from the United States Agency for International Development to jumpstart the search for new tuberculosis (TB) treatments and optimize existing ones.

The very old BCG vaccine continues to be deployed by most countries to help prevent TB.

In 2020, more than 40% of the estimated 9.9 million people who fell ill from TB were neither diagnosed nor treated.

According to the WHO, an estimated 1.5 million people died of TB in 2020.

"While the world was focused on the COVID-19 pandemic, the TB pandemic tightened its grip on the most impoverished parts of the world," said Mel Spigelman, M.D., President and CEO of TB Alliance in a press statement.

"This is the danger we face in letting older diseases linger instead of eradicating them."

TB Alliance's work in drug development is focused on finding new drug candidates and then testing new treatment regimens that include these candidates instead of shepherding individual drug candidates one by one through the lengthy clinical trial process.

TB Alliance will continue developing new formulations of TB treatments appropriate for children who require different dosing than adults. 

In 2010, the WHO established new dosage guidelines for children for the standard drug-sensitive TB regimen, but no new medicines were manufactured according to the new guidelines until TB Alliance and its pharmaceutical partners produced child-friendly doses in 2015.

The most drug-sensitive forms of TB require at least four months of treatment using four anti-TB drugs. 

As of January 22, 2022, there are multiple versions of the existing BCG vaccine available as a generic, with newer versions conducting clinical studies. 

Medical Review by
Jan 22, 2022 • 8:37 am CST

The U.S. Food and Drug Administration (FDA) announced two actions on January 21, 2022, to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.

Previously, the Emergency Use Authorization (EUA) of Veklury was limited to patients requiring hospitalization.

The FDA's approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled phase 3 clinical trial that included 562 non-hospitalized patients.

The primary outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment.

Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). And there were no deaths in either group. 

Furthermore, the authorization of Veklury in certain pediatric patients is based on the extrapolation of efficacy from adult clinical studies.

The agency also revised the EUA for Veklury to additionally authorize the antiviral for the treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. 

Pediatric patients for whom Veklury is authorized will receive doses adjusted for their body weight.

Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, stated in a press release, "Today's actions provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers." 

Based on today's FDA actions, these high-risk non-hospitalized patients may receive Veklury via intravenous infusion for a total of three days for the treatment of mild-to-moderate COVID-19 disease. 

The FDA granted approval and reissued the Veklury antiviral EUA to Gilead Sciences Inc.

Note: COVID-19 antiviral treatments differ from anti-SARS-CoV-2 coronavirus monoclonal antibodies.

Medical Review by
Jan 21, 2022 • 2:04 pm CST

The U.S. National Center for Health Statistics (NCHS) Mortality Surveillance data available on January 20, 2022, found 25.5% of the deaths that occurred during the week ending January 15, 2022 (week #2) were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 4,326 PIC deaths reported for this week, 3,681 had COVID-19 listed, and 623 had pneumonia listed as an underlying or contributing cause of death on the death certificate.

And just 22 listed influenza as the cause of death.

This NCHS data indicates that current PIC mortality is due primarily to COVID-19 (85%) and pneumonia (14%), not influenza.

Previously, the U.S. CDC reported a total of five influenza-associated pediatric deaths that occurred during the 2021-2022 season had been reported.

Two influenza-associated pediatric deaths were reported to CDC during week #2, ending January 15, 2022.

One death was associated with an influenza A(H3) virus, and one death was associated with an influenza A virus for which no subtyping was performed.

These five deaths represent a significant increase from last flu season (2020-2021) when only (1) influenza-associated pediatric death was reported to CDC.

Influenza viruses change from year to year, so influenza vaccines must be updated annually to include the viruses that will most likely circulate in the upcoming season. 

Of the influenza A strains detected, H3N2 is dominant, making up 100% of subtyped samples. Most H3N2 viruses are genetically related to the current flu vaccine virus. However, the CDC identified some antigenic differences as the influenza viruses evolve in 2022.

To be protected against the flu, the CDC encourages most people over six months of age to get an annual flu shot.

Unfortunately, the preliminary estimates for the last flu season indicate children's flu shots decreased 4.1% to 58.2%.

As of January 7, 2022, about 173.3 million doses had been distributed in the U.S.

The presented data are preliminary and may change as more data are received and processed, says the CDC.

Medical Review by
Jan 21, 2022 • 1:39 pm CST

China-based Clover Biopharmaceuticals, Ltd. announced on January 20, 2022, that final efficacy data from SPECTRA, a global clinical trial evaluating its protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), has been published in the peer-reviewed journal, The Lancet.

This data indicates that SCB-2019 (CpG 1018/Alum) achieved primary and secondary efficacy endpoints.

The COVID-19 vaccine candidate also demonstrated 100% efficacy against severe COVID-19 and hospitalization caused by any strain of SARS-CoV-2 in SPECTRA.

And SCB-2019 (CpG 1018/Alum) showed a favorable safety profile with no significant differences observed in systemic adverse events or severe adverse events when compared to placebo.

"We are pleased to have the SPECTRA pivotal Phase 2/3 trial results for Clover's COVID-19 vaccine candidate peer-reviewed and selected for publication in The Lancet," stated Dr. Ralf Clemens, Chairman of the Vaccine Scientific Advisory Board of Clover Biopharmaceuticals, in a press statement issued on January 20, 2022.

"SCB-2019 (CpG 1018/Alum) demonstrated high efficacy in an environment where all of the sequenced strains were variants, and no cases of the original SARS-CoV-2 strain were observed."

"Combined with a favorable safety and reactogenicity profile, Clover's vaccine candidate utilizing well-established protein-based technology may help to overcome vaccine hesitancy and also warrants its further evaluation as a potential universal COVID-19 booster vaccine."

"Clover remains committed to making SCB-2019 (CpG 1018/Alum) available as quickly as possible to populations in need around the world."

Clover is in the process of submitting conditional regulatory approval applications to the NMPA, EMA, and the WHO and plans to commence product launch post conditional approval.

The paper, 'Efficacy of the adjuvanted subunit protein Covid-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomized, placebo-controlled trial,' may be accessed here.

Clover Biopharmaceuticals is a global clinical-stage biotechnology company located in Chengdu, China, committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag™ technology platform is a product development platform for creating novel vaccines and biologic therapies.

Medical Review by