COVID-19

A report launched by pharmaceutical company Takeda UK reveals that, despite heightened public and media attention on the industry’s efforts to develop vaccines and treatments, the COVID-19 pandemic has had little positive impact on perceptions of pharmaceutical companies.

The Pharma: Repurposed report explores the importance of ‘purpose’ to the pharmaceutical industry and provides recommendations on how the sector can convey a stronger purpose to build trust and ultimately improve the lives of patients.

For the report, Takeda UK commissioned Ipsos MORI to conduct online interviews among adults ages 16-75 from the United Kingdom. A total of 1104 interviews were conducted in October 2020 and key findings include: Only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the coronavirus pandemic over the previous six months. Over half (54%) said their impression had stayed the same and 16% said their impression had got worse.

The pandemic has had a positive impact on UK adults’ perceptions of healthcare professionals, with 44% of respondents saying their impression had improved. In contrast, UK adults’ impression of politicians has got markedly worse, with 51% of respondents saying their opinion of government ministers had worsened over the last six months.

When respondents were asked to express their opinion on a range of organisations and roles within the sector, just 38% had a total favourable opinion of pharmaceutical companies.

As per the survey, Over a third of respondents (36%) had neither a favourable nor unfavourable view of the pharmaceutical sector, suggesting that the industry has more work to do to engage the public with its role and activities. The survey revealed a high total favourable result for healthcare professionals (74%), and for healthcare charities (58%). Scientists within the pharmaceutical industry (53%) were also well regarded.

Total unfavourable views of Government ministers stood at 55% and other politicians at 54%. Less than half (48%) of respondents trust the pharmaceutical industry to act in the best interest of society. In contrast, 82% of respondents trust healthcare professionals to act in society’s best interests and over 70% trust healthcare charities to do so.

Jon Neal, MD UK and Ireland at Takeda, said: “The pharmaceutical industry has faced several reputational challenges over the years. However, perhaps now more than ever, the development of new treatments relies on cross-sector collaborations and public trust and willingness to engage with the sector. Therefore, we need to address perceptions of the industry to improve the future of healthcare and ultimately save lives.

“We hope this report will lead to further discussion about how the industry can convey a stronger purpose to build trust with both patients and other healthcare organisations. Employees in pharma companies such as Takeda are completely committed to improving the lives of patients and yet this research shows our commitment to patients and our purpose is not widely understood or accepted. We need to do more and I hope this report will lead to further discussion and opportunities to work with others from across the industry to increase understanding of our role in society and how we operate.”

Ben Page, Chief Executive of Ipsos MORI, commented: “Our research with Takeda suggests that the public have a higher opinion of roles or organisations that articulate a strong purpose around their role in and value to society. The pharmaceutical industry has historically struggled to clearly articulate what it does and what it stands for. If the sector wants to better connect with the public, it needs to start talking much more openly about its activities and values.

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Zydus Cadila announced that it had received an approval from the Drugs Controller General of India (DCGI) to start the Phase 3 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’. The trials which will commence in December will be conducted on 250 patients across 20-25 centres in India. In the Phase II clinical trials study established the early safety, efficacy and tolerability of PegiHep TM and has indicated that Pegylated Interferon alpha-2b having statistical clinical beneficial impact on the patient suffering from moderate COVID 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients. Pegylated Interferon alpha-2b, ‘PegiHepTM is an approved drug and is being re-purposed for the treatment of COVID-19.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “We are encouraged by the results of Phase II study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease. Our efforts are to look at possible treatment options to fight COVID-19 which are safe, can be administered easily and also reduce the disease burden.”

In the Phase 2 clinical trial which was open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative.

In the test arm 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc.

Zydus Cadila is also conducting a similar Phase 2 trial in Mexico. The Company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.

Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List. Zydus Cadila’s Pegylated Interferon alpha-2b, PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients. Given that type I interferons including Interferon alpha have been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science (Hadjadj et al, Bastard et al and Zhang et al), the findings in Zydus Cadila’s Phase 2 study are not surprising. In this study, a single dose of PegiHep at 1 mcg/kg body weight was tested to find out whether the drug could be repurposed for treating moderate COVID-19 patients. In 19 out of 20 patients, a single 1 mcg/kg dose of the drug demonstrated viral clearance as assessed by RT-PCR and a significant improvement in clinical symptoms.

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Pfizer Inc. and BioNTech SE  announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.

The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.

In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies around the world.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German sites will also be leveraged for global supply.

Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.

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New research reveals that tinnitus, a common condition that causes the perception of noise in the ear and head, is being exacerbated by COVID-19 – as well as the measures helping to keep us safe.

The study of 3,103 people with tinnitus was led by Anglia Ruskin University (ARU), with support from the British Tinnitus Association and the American Tinnitus Association. The study involved participants from 48 countries, with the vast majority coming from the UK and the US.

Published in the journal Frontiers in Public Health, the research found that 40% of those displaying symptoms of COVID-19 simultaneously experience a worsening of their tinnitus.

Although the study focused on people with pre-existing tinnitus, a small number of participants also reported that their condition was initially triggered by developing COVID-19 symptoms, suggesting that tinnitus could be a ‘long COVID’ symptom in some cases.

Tinnitus affects an estimated one in eight adults in the UK and is associated with reduced emotional wellbeing, depression, and anxiety.

The new study also found that a large proportion of people believe their tinnitus is being made worse by social distancing measures introduced to help control the spread of the virus. These measures have led to significant changes to work and lifestyle routines.

UK respondents reported this to be a greater issue compared to people from other countries, with 46% of UK respondents saying that lifestyle changes had negatively impacted their tinnitus compared to 29% in North America.

Internal worries such as fear of catching COVID-19, financial concerns, loneliness and trouble sleeping have contributed to making tinnitus more bothersome for 32% of people overall, with external factors such as increased videocalls, noisier home environments, home schooling and increased coffee and alcohol consumption also cited by respondents. Females and the under-50s found tinnitus significantly more bothersome during the pandemic.

The study noted that as well as increasing the severity of tinnitus symptoms, the COVID-19 pandemic has also made it more difficult for people to access healthcare support for the condition. This could further increase emotional distress and worsen tinnitus symptoms, creating a vicious cycle. Before COVID-19, more than eight out of 10 UK patients were already unhappy with the treatment options available from their health professional.

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The Council of Scientific & Industrial Research (CSIR), India’s premier research organization, and Mylan Laboratories Limited, the India-based subsidiary of leading global pharmaceutical company Mylan, today announced a partnership to address unmet patient needs amidst the evolving COVID-19 pandemic. Under the partnership, CSIR’s constituent laboratory Indian Institute of Chemical Technology (CSIR-IICT), and Mylan will collaborate to identify potential therapies for COVID-19.

A series of clinical trials will be conducted towards new and innovative solutions to manage COVID-19 pandemic in India as part of this collaboration. The first of the clinical trial to be rolled out is a multiple arm phase 3 study that will be conducted in adult patients with mild to moderate COVID -19 at risk of complications.

Director General of CSIR, Dr. Shehkar C Mande stated, “The current collaboration with Mylan is a significant milestone and during the current COVID-19 pandemic, CSIR has prioritized conducting clinical trials of well proven drugs in partnership with industry towards the development of multiple therapeutic options for COVID-19.” 

Director of CSIR-IICT, Dr Chandrasekhar said, “CSIR is delighted to associate with Mylan as knowledge and scientific partner, and looks forward to working with the company, especially given Mylan’s vast industry experience in clinical trials and commercialization.”  

Mylan Chief Operating Officer, Sanjeev Sethi stated, “Our collaboration with CSIR, India’s premier research organization, is a strategic step forward aimed at identifying effective treatments for patients with COVID-19. In addition to bringing forward new indications, this partnership will also help us identify multiple molecules that can potentially be leveraged in therapies for various other infectious diseases in the future. Mylan is cognizant of its responsibility in fighting this pandemic and continues to leverage its global resources and capabilities including R&D, clinical research, regulatory, manufacturing and supply chain, while engaging with key stakeholders to serve patients in need.”

The application for the clinical trials has been submitted to the Drugs Controller General of India (DCGI) for regulatory approval.

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The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on wellstudied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are very pleased to partner with Dr. Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”

Prof. Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 in Moscow, said, “The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”

On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com

On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020.

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Shadow Pharma Venture Private Limited, Mumbai and Gplife Healthcare Private Limited, Surat have announced that the next generation Phytochemistry technology-based Nutraceutical formulations ACT- 12 and ACT - 13 have successfully cleared Phase II clinical trials for the treatment of COVID 19 positive hospitalized patients.

The formulations were compared for its safety and clinical efficacy against standard of care in COVID 19 patients.

60.0% of cases from Test Group showed PCR negativity compared to 40.0% in standard Group at Day 4. No Patient continued to remain Covid positive after the 10th day in the Test group and 7 Patients remained Covid positive after 10 days in the standard group. The IgG and IgM immunoglobulin levels were noticed to be higher demonstrating improved antibody functionality and thereby the immunomodulatory activity offered.

Anti-inflammatory effect by Lowering LDH, CRP with improvement in SpO2 & Thrombocytopenia can reduces risk of lung fibrosis.

Kiran Narasimha Pai (MBA IIM Calcutta), Advisor to Gplife Healthcare, said that “These results are among the best results for any Nutraceutical or Phytochemistry based formulation in the world for the treatment of COVID-19. If the same results with No mortality and 40% faster recovery rates can be replicated in a much larger Phase III trial, then we could be looking at the end of, at least, the severity of the COVID-19 pandemic."

He further said, "Since these products have essentially very low side effects and are FSSAI approved, they can be started as an adjuvant treatment globally, almost immediately”.

Prasad Kanitkar, Chief Technical Officer (CTO), Shadow Pharma added “These products and technologies are the outcome of putting Science and Nature together for the betterment of human beings and hope of life in ongoing pandemic.” He congratulated Dr. Shridhar Pandya Scientist and Director Gplife on making this research a reality at the exact time when the whole world needed it. Shadow Pharma Venture Pvt. Ltd. Mumbai has tied up with Gplife Health Care Pvt. Ltd. to commercialize its COVID 19 ACT 12 & ACT 13 Treatment Therapy and remaining Nutraceutical portfolio.

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COVAXIN vaccine shows remarkable immunogenicity and protective efficacy against SARS-CoV-2 (new coronavirus). It’s research name is BBV152 which an inactivated SARS-CoV-2 vaccine.

Two doses vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques (divided into four groups equally). One group was administered with placebo, while three groups were immunized with 3 different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the 2nd dose. The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey.

No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group. Adverse events were not seen in animals immunized with a two-dose vaccination regimen.

Genomic RNA (gRNA) was detected from nasal swab (NS) specimens of all animals in the placebo group from 1 to 7 DPI (Days Post-Infection). Viral clearance was observed in NS specimens of all the animals from the vaccinated group on 7 DPI. Subgenomic RNA (sgRNA) was detected in two of five animals at 3 DPI and one of five animals at 7 DPI of the placebo group.  sgRNA was detected in the NS sample of only one animal of the vaccinated group IV on 5 DPI.

Neutralizing antibodies and IgG responses were observed from 3rd-week post-immunization in vaccinated groups. IgG titer rose in an increasing pattern with the highest response in group III. The presence of gRNA in NS was observed in the placebo group until 7 DPI. Vaccinated groups had no detectable gRNA in NS on 7 DPI indicating the ability of vaccine candidates to limit upper respiratory tract viral replication, which is a key factor determining the virus transmission.

gRNA and sgRNA were not detected in the Bronchoalveolar lavage fluid from 5 DPI suggesting that vaccination hindered virus replication and enabled faster clearance from lower airway protecting the animals. gRNA was detected in multiple organs at necropsy in the placebo group, whereas it was found to be cleared in the vaccinated groups.

Altogether this study demonstrates that a two-dose vaccination regimen using 3µg dose of the vaccine candidate with adjuvant induce a significant immune response and provide effective protection in animals challenged with SARS-CoV-2.

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