UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron XBB 1.5 subvariant, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The vaccine has been approved for use in individuals from six months of age.

The adapted vaccine works in the same way as the original vaccine by causing the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.

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The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus

High levels of exposure to the SARS-CoV-2 virus may reduce or overcome the protection that COVID-19 vaccination and prior infection provides, according to a study conducted in the US. The findings, published recently in the journal Nature Communications, suggest that in densely crowded settings, control measures that reduce levels of exposure to the virus — such as masking, improved ventilation, and distancing — may afford additional benefit in preventing new infections among people who have been vaccinated or previously infected.

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus.

“It’s really hard to find a population, such as the residents of the Connecticut Department of Correction, where we know the type of exposure somebody has and we know their vaccination and prior infection status,” said Margaret Lind, lead author of the research paper, and an associate research scientist at Yale University, US.

The researchers tracked infections among 15,444 residents of Connecticut correctional facilities between June 2021 and May 2022, when the state experienced two epidemic waves due to the emergence of the COVID-19 Delta and Omicron variants.

They also determined which people had resided with a COVID-19- positive cellmate and, as a result, had high exposure to the COVID-19 virus.

The study found that during the Delta and Omicron epidemic waves, immunity acquired after a vaccination, prior infection, and both vaccination and infection (hybrid immunity) was weaker when residents were residing with an infected inmate.

Specifically, during the Delta wave, vaccination was 68 per cent effective at preventing infection in residents without a documented exposure but was just 26 per cent effective in residents with exposure to an infected cellmate, the researchers said. A previous infection was 79 per cent effective in preventing infection in residents without a documented exposure but was 41 per cent effective when a resident was exposed to an infected person in their cell, they said.

Hybrid immunity provided the highest level of protection, at 95 per cent and 71 per cent effectiveness, in residents without a documented exposure and with a cell exposure, respectively, according to the researchers.

While the overall protection afforded by vaccination, prior infection, and hybrid immunity was lower during the epidemic wave with the more transmissible Omicron variant, the same pattern in the levels of protection was observed, they said.

The researchers also found that vaccination was 43 per cent effective at preventing infection in residents without documented exposure but was just 4 per cent in residents who shared a cell with an infected person.

A previous infection was 64 per cent effective without a documented exposure but was only 11 per cent effective when a resident was exposed to an infected person in their cell.

Although hybrid immunity afforded higher levels of protection during the Omicron wave, it was only 20 per cent effective in residents with an exposure in their cell as compared to being 76 per cent effective in residents without documented exposure.

“This research is the first study, as far as we are aware, that provides real-world evidence for the exposure-dependent or ‘leaky’ nature of the immunity afforded by vaccination and infection,” Lind added.

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The Biden administration plans to urge all Americans to get a booster shot for the coronavirus this autumn to counter a new wave of infections, informed a White House official.

The official said that while the Centers for Disease Control and Prevention are reporting an increase in infections and hospital admissions from the virus, overall levels remain low.

Moderna recently said initial data showed its updated COVID-19 vaccine is effective against the “Eris” and “Fornax” subvariants in humans.

Moderna and other COVID-19 vaccine makers Novavax, Pfizer and German partner BioNTech SE have created versions of their shots aimed at the XBB.1.5 subvariant.

Pending approval from health regulators in the US and Europe, the companies expect the updated shots to be available in the coming weeks for the autumn vaccination season.

“We will be encouraging all Americans to get those boosters in addition to flu shots and RSV shots,” the official said, referring to the Respiratory Syncytial Virus.

(Edits by EP News Bureau)

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Researchers and clinicians from the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust are part of the ongoing OCTAVE (Observational Cohort Trial-T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2) trial, which is led by the Universities of Glasgow, Birmingham and Oxford and a consortium of leading UK institutions.

Published in Nature Medicine, the latest report contains important new data on infection rates, disease severity and deaths in the patient groups, who were studied up to one year after their first vaccination.

Preliminary data from the OCTAVE study in August 2021 showed that a significant proportion of clinically at-risk patients with immunocompromised or immunosuppressed conditions, mounted a low, or undetectable, immune response after two doses of the same SARS-CoV-2 vaccine. Now, in new peer-reviewed data, researchers are able to share the real-world infection outcomes for this clinically at-risk group.

Data from the study cover the time period from 2021 to mid-2022, and include patients infected with the Alpha, Delta and Omicron strains of SARS-CoV-2. The data do not estimate the impact of third and fourth vaccinations, which have since been offered to patients in the groups studied.

These new data show that, while in most at-risk patient groups the overall Covid-19 infection rates were low, the risk of severity and death from SARS-CoV-2 was high in a sub-group of conditions, despite vaccination. This was particularly the case during the Delta wave. Furthermore, the data show that while Omicron, now the dominant SARS-CoV-2 strain worldwide, saw a rise of infection rate among at-risk patients, fewer of them became severely unwell or died.

The OCTAVE findings in detail

• There were 20 hospital sites across the UK who enrolled 2,686 patients with reduced function of their immune systems to the trial.
• Overall, 474 patients in the study became ill with Covid-19 up to one year after the date of their first vaccination. 111 of these infections were identified as either Alpha (1) or Delta (110) variants and 336 were identified as Omicron. 48 people were admitted to hospital because of a Covid-19 infection and sadly, 15 people died from the disease.
• Most infections (76 per cent) occurred more than six months after the second vaccination and were in patients with a kidney transplant, inflammatory arthritis and Crohn’s Disease. The majority of these infections were also first-time SARS-CoV-2 infections. Infections occurring within six months of the second vaccination were not more severe than those reported six months or longer post second vaccination.
• Most infections (90 per cent) were mild in severity, including some asymptomatic cases. Severe cases requiring hospitalisation or death was reported in 9.8 per cent of infections and occurred predominantly in patients with renal disease. Patients infected in the Delta wave were more likely to have serious infection than those infected in the Omicron wave.
• In patients who did not mount a successful immune response to two Covid-19 vaccinations, the rate of infection was higher when compared to those in the study that did mount an immune response after vaccination.
• In some disease groups, the overall infection rates were low – possibly because of continued shielding at the time – but the proportion of severe cases within these groups were high. This was most notable in patients with ANCA Associated Vasculitis on rituximab, auto and allogeneic stem cell transplant and CART-T cell treated patients.
• Low rates of severe disease were reported in patients with Crohn’s disease and ulcerative colitis.

OCTAVE (Observational Cohort Trial-T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2) is a multi-centre, UK-wide trial led by the University of Glasgow, co-ordinated by the University of Birmingham’s Cancer Research UK Clinical Trials Unit and delivered by a national consortium of leading academic and clinical centres. It was set up in the middle of the Covid-19 pandemic to evaluate, in real time, the immune responses following Covid-19 vaccination in patients with immune-mediated inflammatory diseases such as cancer, inflammatory arthritis, diseases of the kidney or liver, or patients who are having a stem cell transplant.

Previously, preliminary data released from OCTAVE in 2021 showed that while most patients mounted a successful immune response after two doses of the vaccine, some patients with certain immunosuppressed conditions mounted a low, or undetectable, immune response. The study found that overall 12 per cent of patients on the trial failed to develop antibodies, with an additional 27 per cent only generating low levels of antibodies. Some patients also failed to generate adequate T cell responses after vaccination. Vaccine failure rates were higher in some subgroups including patients with ANCA-associated vasculitis on the drug rituximab, patients receiving haemodialysis and also on immunosuppressive therapy, and patients who were solid organ transplant recipients.

The study used a variety of state-of-the-art immune tests performed on blood samples taken before and/or after Covid-19 vaccination, as well as infection and severity data on patients to better understand the real-world impact of a low vaccination response in these patient groups.

The study, ‘SARS-CoV-2 specific humoral and T cell responses and clinical outcomes following COVID-19 vaccination in patients with immune suppressive disease-a phase-III multicentre study-OCTAVE’ is published in Nature Medicine. The work was funded by the Medical Research Council.

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Adar Poonawalla, CEO, Serum Institute of India (SII) informed that the company has restarted manufacturing of COVID-19 vaccine Covishield amid rising numbers of cases of the virus infection. He said the company already has six million booster doses of Covovax vaccine available and adults must take the booster shot.

“Just as a precaution, at risk we have done it so that people have Covishield as a choice if they want it,” Poonawalla told PTI.

He further said Serum Institute of India (SII) will make six to seven million doses of Covishield available in 90 days and it could take up to nine months to further build up the stock based on demand.

The company had stopped manufacturing of Covishield in December 2021.

Reacting to reports of COVID-19 vaccine shortages amid the rising cases, Poonawalla said it’s incorrect to say that there are no stocks and “giving a wrong picture to the people”.

“There is enough stock available from all manufacturers,” he asserted.

On the other hand, he said, “There is no demand…that’s why there is no stock with the hospitals. It is not that the vaccine manufacturers are not interested in making it. We’re interested in making it, if of course the demand is there. That’s a normal standard practice.”

On Covovax which has been approved as a booster dose for 18-years and above, he said, “We have six million doses ready but the demand is exactly zero at the moment.”

Poonawalla asserted that “Covovax is the best booster to take” for adults and elderly as it has “excellent neutralising” antibodies for the Omicron and XBB variants of the virus.

Encouraging people to take the booster dose, he said, “The point I’m trying to make is that the private citizens, who should mask up, and the elderly, especially should come in and pick up the precautionary dose. They have to come and pay for it. They have to pay Rs 225 for the vaccine plus Rs 150 or Rs 200 for the administration charges.

He further said there are also other vaccines approved on the CoWin app and SII’s Covovax vaccine also got approved two days back, adding people just need to go to vaccination centres to get the booster dose.

(Edits by EP News Bureau)

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People exposed to higher levels of air pollution before the pandemic had lower antibody responses to COVID-19 vaccines, according to a study. In particular, exposure to fine particulate matter (PM2.5), nitrogen dioxide (NO2) and black carbon was associated with about a 10 per cent decrease in IgM and IgG antibody responses in people without prior infection, the researchers said.

The findings, published in the journal Environmental Health Perspectives, provide further evidence on the adverse effects of air pollution on the immune system.

“Air pollution has been linked to adverse health outcomes, including lung cancer, cardiovascular and respiratory disease, and diabetes,” said Manolis Kogevinas from the Barcelona Institute for Global Health (ISGlobal).

“Air pollutants have been shown to affect immune responses, so in this study we wished to determine whether air pollution also affects antibody responses to COVID-19 vaccines,” said Kogevinas.

The team analysed data from 927 participants aged 40 to 65 years, who answered questionnaires and gave blood samples in the summer of 2020 and in the spring of 2021. All had received one or two doses of the main COVID-19 vaccines administered in Spain made by AstraZeneca, Pfizer or Moderna.

The research team measured IgM, IgG and IgA antibodies to five viral antigens (three of them on the spike protein contained in the vaccine). Exposure to PM2.5, black carbon, NO2 and ozone (O3) was estimated for each participant based on their address before the pandemic.

“The collaboration of all volunteers in the cohort, with more than ten years of data, has allowed us to reliably estimate the level of environmental exposure of all participants,” said Rafael de Cid, co-author of the study.

The results show that in uninfected individuals, pre-pandemic exposure to PM2.5, NO2 and black carbon was associated with a 5 to 10 per cent reduction in vaccine-induced spike antibodies.

The decrease in antibodies was shown both for early IgM responses and late responses measured by IgG, the researchers said.

The IgG response after the first dose peaked later in participants exposed to higher air pollution levels, and lower IgG levels persisted for several months after vaccination. Results were similar for the three vaccines.

“Air pollution can induce chronic inflammation, which has been associated with a negative effect on vaccine efficacy,” said Carlota Dobano, co-senior author of the study, together with Cathryn Tonne.

“Our findings are consistent with evidence that persistent organic pollutants reduce vaccine responses in children,” Dobano added.

The fact that previous infections lead to higher vaccine responses could explain why the effect of pollutants was only observed in people without a prior infection, the researchers said.

However, the role of long-term exposure to air pollution on hybrid immunity (infection plus vaccination) deserves further investigation, they added.

(Edits by EP News Bureau)

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China has approved its first domestically developed mRNA vaccine against COVID-19, CSPC Pharmaceutical Group said.

China, whose home-grown vaccines are seen as less effective than the Moderna and Pfizer-BioNTech mRNA shots, has been racing to develop vaccines using messenger RNA (mRNA) technology since early 2020.

The long-awaited approval comes as infections have fallen sharply across China since it suddenly dropped its strict “zero-COVID” curbs in December, making the sales outlook for the newly approved vaccine moderate.

But it would give China an additional option to tackle future outbreaks and a base for development against newly emerging variants, scientists said.

Its top leaders declared a “decisive victory” over COVID last month.

CSPC said its vaccine trials showed adverse effects were substantially lower in an elderly group compared with an adult group, which could help China, which has stressed the need to focus on protecting its vulnerable elderly population.

The company said its independently developed mRNA vaccine SYS6006 targets some major Omicron variants and its booster dose showed a good neutralisation effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. in clinical trials.

In a study of 4,000 participants from Dec. 10 to Jan. 18 when China was experiencing a surge in infections, the vaccine showed efficacy of 85.3 per cent 14 to 28 days after booster vaccination.

CSPC did not say how many doses it plans to produce. It said the vaccine could be stored at 2 degrees to 8 degrees C (35.6 degrees to 46.4 degrees F) for a long time.

The firm won emergency approval for clinical trials of the mRNA shot in April last year, around the same time as CanSino, another China-based company that is testing an mRNA Omicron booster shot.

(Edits by EP News Bureau)

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Indian Institute of Technology Madras (IIT Madras) researchers have developed an online open-source database of coronaviruses’ neutralising antibodies encompassing crucial features such as binding affinity and neutralisation profiles (IC₅₀ and EC₅₀) o antibodies.

The database called ‘Ab-CoV’ contains detailed information about all COVID-related antibodies identified so far, including the source of each antibody, and the viral protein(s) and virus strains they recognise. ‘Ab-CoV’ can also aid in the development of drugs against new variants of SARS-CoV-2.

Ab-CoV database includes 1,780 coronavirus-related antibodies including 211 nanobodies and contains more than 3,200 data points on half maximal inhibitory concentration (IC₅₀), half maximal effective concentration (EC₅₀) & binding affinity (K_D).

This work has been published in the reputed peer-reviewed journal Bioinformatics. The authors of this paper include Dr Puneet Rawat, Divya Sharma, Dr R Prabakaran, Fathima Ridha, Mugdha Mohkhedkar, Dr Vani Janakiraman, and Prof M Michael Gromiha from Department of Biotechnology, Bhupat and Jyoti Mehta School of Biosciences, IIT Madras.

Stressing the uniqueness of Ab-CoV, Prof M Michael Gromiha, Faculty, Department of Biotechnology, IIT Madras, said, “Some of the data in the Ab-CoV database has already been used to understand the relationship between structural features and binding affinities of spike protein-antibody complexes as well as antibody repurposing.”

Further, Prof Gromiha said, “Ab-CoV also has a wide range of search and display options through which users can directly search and download the processed data, based on the antibody’s name, viral protein epitope, neutralised viral strain, antibody, and nanobody. It also has the option to view structures of antibodies or viral proteins in a 3D model.”

The information compiled in this database assists researchers in:

Ø Antibody engineering

Ø Analysing immune escape for known and future variants of SARS-CoV-2

Ø Computational studies on neutralising antibodies, and

Ø Relating structural features with binding affinity.

Elaborating further, Dr Vani Janakiraman, Faculty, Department of Biotechnology, IIT Madras, said, “AbCoV is an exhaustive repository of antibodies, not just specific to SARS CoV-2 but also to other members of the coronavirus family such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) viruses. This repository would aid in comparative studies among different neutralising antibodies across coronaviruses and to assess their properties, interaction patterns with epitopes on the native and mutant viral proteins. Such an effort eventually would help to gauge the efficacy of these antibodies towards existing and emerging viral variants.”

Although large amounts of experimental and computational data have been stored online to understand the virus, the emergence of new variants prompted researchers to gather new and comprehensive information. Such efforts will help to develop newer drugs and deal better with disasters that affect human health and economies, globally.

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A team led by Japanese researchers has recently been successful in characterising the new SARS-CoV-2 Omicron XBB.1.5 variant, which was first detected in October 2022. They discovered that the SARS-CoV-2 Omicron XBB.1.5 variant, prevalent in the Western hemisphere, has high transmissibility and infectivity. Their findings were published on January 31, 2023 in volume 23 of The Lancet Infectious Diseases.

Senior author Prof Kei Sato from the Division of Systems Virology, The Institute of Medical Science, The University of Tokyo, Japan said, “Because the Omicron XBB.1.5 variant can spread more rapidly than previous variants and has a potential to cause the next epidemic surge, we should carefully monitor it to safeguard public health.”

While studying emerging variants of the SARs-CoV-2 Omicron lineage, the research team made a startling discovery: the SARS-CoV-2 Omicron XBB.1.5 variant has a novel mutation in the spike (S) protein—the protein that anchors the virus firmly to the human angiotensin converting enzyme-2 (ACE2) receptor, thus facilitating the invasion of human cells. The serine-to-proline amino acid mutation noted at residue no. 486 in the S protein is virologically concerning because of a variety of reasons.

Sharing his concerns, first author Keiya Uriu from the Division of Systems Virology, Department of Microbiology and Immunology, The University of Tokyo, Japan, said, “In late 2022, the SARS-CoV-2 Omicron BQ.1 and XBB lineages, characterised by amino acid substitutions in the S protein and increased viral fitness, had become predominant in the Western and Eastern Hemisphere, respectively. In 2022, we elucidated the characteristics of a variety of newly emerging SARS-CoV-2 Omicron subvariants. At the end of 2022, the XBB.1.5 variant, a descendant of XBB.1 that acquired the S:S486P substitution, emerged and was rapidly spreading in the USA.”

To gain mechanistic insights into the infectivity, transmissibility, and immune response associated with XBB.1.5, the team conducted a series of experiments. For instance, upon conducting epidemic dynamics analysis—statistical modeling that facilitates the analysis of the general characteristics of any epidemic—the team realised that the relative effective reproduction number (R_e) of XBB.1.5 was 1.2-fold greater than that of the parental XBB.1. This indicated that an individual with the XBB.1.5 variant could infect 1.2 times more people in the population than someone with the parental XBB.1 variant. Moreover, the team also realised that, as of December 2022, XBB.1.5 was rapidly outcompeting BQ.1.1, the predominant lineage in the United States.

Co-first-author Jumpei Ito from the Division of Systems Virology, remarked, “Our data suggest that XBB.1.5 will rapidly spread worldwide in the near future.”

The team also studied the virological features of XBB.1.5 to determine how tightly the S protein of the new variant interacts with the human ACE2 receptor. To this end, the researchers conducted a yeast surface display assay. The results showed that the dissociation constant (K_D) corresponding to the physical interaction between the XBB.1.5 S receptor-binding domain (RBD) and the human ACE2 receptor is significantly (4.3-fold) lower than that for XBB.1 S RBD. “In other words, the XBB.1.5 variant binds to human ACE2 receptor with very high affinity,” explained Shigeru Fujita from the Division of Systems Virology.

Further experiments using lentivirus-based pseudoviruses also showed that XBB.1.5 had approximately three-fold higher infectivity than XBB.1. These results suggest that XBB.1.5 exhibits a remarkably strong affinity to the human ACE2 receptor, which can be attributed to the S486P substitution.

The study by Prof. Sato and his team led to another important discovery from an immunisation perspective. The XBB.1.5 S protein was found to be highly resistant to neutralisation antibodies elicited by breakthrough infection with the BA.2/BA.5 subvariants. In other words, patients with prior infection from the BA.2/BA.5 subvariants may not show robust immunity against XBB.1.5, increasing their chances of infection and disease.

“The results of our virological experiments explain why the Omicron XBB.1.5 variant has a higher transmissibility than past variants: This variant acquired strong binding ability to human ACE2 while maintaining a higher ability to escape from neutralising antibodies,” said Yusuke Kosugi from the Division of Systems Virology, Department of Microbiology and Immunology.

Contributing members of The Genotype to Phenotype Japan (G2P-Japan) Consortium concluded, “The SARS-CoV-2 Omicron XBB.1.5 variant does show enhanced transmissibility. Although few cases have been detected in the Eastern hemisphere, it could become a looming threat. Imminent prevention measures are needed.”

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The National Medical Products Administration (NMPA) of China has conditionally approved two homegrown oral drugs Simcere Pharmaceutical’s Xiannuoxin and Shanghai Junshi Biosciences‘ Mindevir for the treatment of mild to moderate COVID-19. Drug regulators in China are focusing on approving homegrown antiviral therapies with the ability to tackle new COVID-19 variants, says GlobalData.

According to GlobalData’s Pharma Intelligence Center, there are currently 16 COVID-19 drugs in clinical development in China, five of which are in Phase III. Most of these drugs in the Phase III stage are targeting various subtypes of COVID-19 omicron variants.

Anupama Mishra, Pharma Analyst at GlobalData, comments, “There are very limited antiviral drugs, such as Pfizer‘s paxlovid and Genuine Biotech’s azuvidine, marketed in China. Hence, there is a need to increase the number of approved therapies.”

Currently, seven homegrown Chinese drugs have been granted either official or conditional approval for treating COVID-19. To increase market access, Chinese regulators have now added all homegrown drugs to the national medical reimbursement list, including Xiannuoxin (ritonavir and simnotrelvir) and Mindevir (remdesivir).

Xiannuoxin is a small molecule oral therapy targeting the 3C-like protease, a key enzyme in the replication and life cycle of COVID-19. Notably, Xiannuoxin’s pivotal Phase II/III clinical trial is the first in the world to investigate Chinese patients infected with the COVID-19 omicron variant. The study is ongoing and trial data is not currently available.

Furthermore, VV116 is a new oral nucleoside analogue antiviral drug, which, in a Phase III trial, demonstrated non-inferiority to paxlovid with respect to the time to sustained clinical recovery, with fewer safety concerns. These newly approved drugs will provide stiff competition to the existing antiviral COVID-19 drugs marketed in China.

According to GlobalData COVID-19 dashboard, as of 14 February 2023, China has 4,903,517 confirmed cases and 101,016 deaths due to COVID-19. The cases peaked in December 2022, after the abandonment of the Zero-COVID policy.

Mishra concludes, “It is important for Chinese pharma companies to increase market access by launching mass production and distribution of COVID-19 therapies at affordable consumer prices. Further approval of effective COVID-19 therapies will strengthen the healthcare infrastructure by increasing clinical recovery and thereby reducing hospitalisations.”

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