Pfizer and BioNTech to deliver 100 million doses of Covid-19 vaccine to EU
20 april | vaccines
Pfizer and BioNTech are set to deliver an additional 100 million doses of their Covid-19 vaccine COMIRNATY to the 27 European Union (EU) member states this year.
COMIRNATY, or the Pfizer-BioNTech Covid-19 vaccine, has received conditional marketing authorisation from the European Medicines Agency (ENCePP) for preventing the disease in people aged 16 years and above.
The latest development comes after the EU exercised its option under an expanded advanced purchase agreement signed in February.
The move to procure additional doses of the vaccine takes the total doses for supply to EU member states to 600 million.
Pfizer chairman and CEO Albert Bourla said: “We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.
“To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the EU in Q2, a four-fold increase on Q1’s agreed quantity.”
For the supply to the EU, the vaccines will be produced in BioNTech and Pfizer’s manufacturing sites in Europe.
On another note, Johnson & Johnson has sought permission from the Indian drug regulator Central Drugs Standard Control Organisation to carry out the Phase III clinical trial of its single-dose Covid-19 vaccine in the country and import licence, PTI reported.
20 April | Clinical trials
CANSINO BIOLOGICS TO START CLINICAL TRIALS OF INHALED COVID-19 VACCINE
Chinese company CanSino Biologics is set to commence clinical trials of a Covid-19 vaccine that can be administered through inhalation.
CNBC reported that, in collaboration with the Beijing Institute of Biotechnology (BIB), CanSinoBIO is developing the inhalation vaccine.
The news channel quoted CanSino Biologics co-founder and chief executive Xuefeng Yu as saying that an inhaled vaccine could be more effective compared to injected ones as SARS-COV-2 enters the human body through the airways.
Yu added that, theoretically, an inhaled vaccine can activate antibodies or T cells in the airways and offer extra protection.
In the event of protection layer failure and the entry of the virus deep into the body, other parts of the immune system could still work against the virus.
20 April | Clinical trials
NIH-FUNDED TRIAL TO ASSESS REPURPOSED DRUGS FOR COVID-19 TREATMENT
The National Institutes of Health (NIH) is set to fund the Phase III ACTIV-6 clinical trial to analyse various prescription and over-the-counter medications that are currently available for self-administration to treat Covid-19 symptoms.
With an initial investment of $155m from NIH, the large, randomised, placebo‑controlled trial will provide evidence-based treatment options for most adult Covid-19 patients with mild-to-moderate symptoms and do not require hospitalisation.
As per the ACTIV-6 protocol, up to seven FDA-approved drugs for other conditions will be explored through an approach called drug repurposing.
The safety and effectiveness of these drugs will be assessed in treating mild to moderate Covid-19.
The trial will enrol up to 13,500 Covid-19-positive subjects aged 30 or above with two or more mild-to-moderate disease symptoms for seven days.
20 april | vaccines
RUSSIA’S SPUTNIK V COVID-19 VACCINE SHOWS 97.6% EFFICACY
The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) have reported that the Sputnik V Covid-19 vaccine showed a 97.6% efficacy.
This was based on the analysis of data on disease infection rate among people receiving both shots of the vaccine.
The vaccine, which is based on an established and well-studied platform of human adenoviral vectors, uses two different vectors for the two jabs for vaccination.
Data from 3.8 million Russians who received both components of Sputnik V from 5 December last year to 31 March this year, as part of the mass-scale civil inoculation drive revealed an infection rate of 0.027% starting from the 35th day on administering the first dose.
Furthermore, the disease incidence among unvaccinated adults was 1.1% from the 35th day after launching mass vaccination in the country.
So far, Sputnik V is approved for use in 60 countries and is positioned as the second among Covid-19 vaccines worldwide in terms of approvals issued by various regulators.
19 april | deals
ASTRAZENECA GETS US CLEARANCE FOR PROPOSED ALEXION ACQUISITION
The US Federal Trade Commission has granted clearance to AstraZeneca for its proposed acquisition of Alexion Pharmaceuticals for approximately $39bn or $175 a share.
The latest development comes after completing clearances in Canada, Brazil, Russia and others, while other regulatory clearances remain incomplete in countries including the UK, EU and Japan.
AstraZeneca executive director and chief financial officer Marc Dunoyer said: “These clearances further advance us towards closing our acquisition of Alexion.
“We remain focused on the next chapter for AstraZeneca and Alexion, building on our combined expertise in immunology and precision medicines and our shared ambition to bring more innovative medicines to patients worldwide.”
Last December, AstraZeneca announced the proposed acquisition of Alexion to boost its scientific presence in immunology by adding the latter’s advanced complement-technology platforms and robust pipeline.
On concluding the acquisition, anticipated in the third quarter of this year, a specialised business unit, known as ‘Alexion, The AstraZeneca Rare Disease Unit’, will be set up in Boston, US.
19 april | regulation
FDA REVOKES EUA FOR LILLY’S COVID-19 ANTIBODY THERAPY BAMLANIVIMAB
The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) granted to Eli Lilly’s investigational therapy bamlanivimab (LY-CoV555) 700mg alone for treating mild-to-moderate Covid-19 in adults and certain paediatric patients.
A recombinant, neutralising human IgG1 monoclonal antibody bamlanivimab is directed against SARS-CoV-2 spike protein. It can potentially inhibit viral attachment and entry into human cells, thereby neutralising the virus that causes Covid-19.
The latest development comes after Lilly requested the FDA to revoke the authorisation due to the SARS-CoV-2 variant issue in the US and the full availability of bamlanivimab and etesevimab together.
According to an ongoing analysis of emerging scientific data, a surge in viral variants that are resistant to bamlanivimab alone resulted in a high risk for treatment failure.
Therefore, the FDA determined that bamlanivimab’s benefits when administered alone no longer prevail over the risks for its authorised use and revoked EUA.
Last November, Lilly received FDA EUA for bamlanivimab alone for treating mild-to-moderate Covid-19 in adults and paediatric patients.
Inovio’s Covid-19 vaccine induces immune responses against variants
Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern.
Oxford University expands Com-COV2 dose-mixing study with Novavax’s Covid-19 vaccine
The University of Oxford has expanded the Comparing Covid-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2) study to include the Novavax and Moderna vaccines for the disease treatment.
Earlier, the researchers had selected the Oxford-AstraZeneca vaccine and the Pfizer vaccine to investigate their alternating doses.
US pharma lobby unveils new drug access campaign
Pharmaceutical Research and Manufacturers of America (PhRMA) has released a series of policies it says will make American healthcare more accessible and affordable.
The campaign, titled ‘Building a Better Health Care System: PhRMA’s Patient-Centered Agenda’, outlines three key goals: ending the pandemic and building a more resilient healthcare system, making medicines more affordable, and building a more just, equitable healthcare system.
Moderna’s Covid-19 variant vaccines boost neutralising titers in study
Moderna’s Covid-19 variant vaccines showed an increase in neutralising titers against SARS-CoV-2 variants of concern according to the latest data from a preclinical study of its candidates mRNA-1273.351 and mRNA-1273.211.
Dr Reddy’s gets approval for import of Russia’s Covid-19 vaccine
The Drug Controller General of India has granted permission to Dr Reddy’s Laboratories to import Russia’s Covid-19 vaccine, Sputnik V, into the country for restricted use in emergency situations.
19 april | covid-19
SINOVAC’S COVID-19 VACCINE PREVENTS 67% SYMPTOMATIC INFECTIONS IN STUDY
The Chilean Ministry of Health has reported that the Chinese pharmaceutical company Sinovac Covid-19 vaccine CoronaVac demonstrated to be up to 67% effective in preventing symptomatic infections in a study.
Named ‘Effectiveness of the inactivated CoronaVac vaccine against SARS-CoV-2 in Chile’, the study showed that after 14 days of administering the second dose, CoronaVac was 85% effective in preventing hospitalisation.
It also had 89% effectiveness in preventing intensive care unit admission and 80% effectiveness in preventing death caused by the virus.
Xinhua quoted Chilean Health Minister Enrique Paris as saying that the vaccine being used by Chile is showing effectiveness.
“We have to continue vaccinating and we cannot relax self-care measures.”
The study included approximately 10.5 million individuals aged 16 years or above.
16 april | regulation
EMA STARTS REVIEW OF GSK AND VIR’S MONOCLONAL ANTIBODY FOR COVID-19
The European Medicines Agency (EMA) has started a review of GlaxoSmithKline (GSK) and Vir Biotechnology’s investigational dual-action SARS-CoV-2 monoclonal antibody VIR-7831 (GSK4182136) for treating Covid-19 patients.
VIR-7831 is an investigational dual-action antibody designed for increasing concentration in the lungs to guarantee optimal penetration into SARS-CoV-2 affected airway tissues.
The antibody treatment is intended for adults and adolescents aged 12 years and above weighing at least 40kg who do not need supplementary oxygen and are at high risk of progressing to severe Covid-19.
EMA’s Committee for Human Medicinal Products (CHMP) is conducting the review and will offer recommendations across the EU for national authorities to make evidence-based decisions for the early use of the medicine before obtaining formal marketing authorisation.
Aurinia reports favourable assessment of LUPKYNIS in ICER
Aurinia Pharmaceuticals has announced a positive cost-effectiveness assessment of LUPKYNIS (voclosporin) based on the Institute for Clinical and Economic Review (ICER) revised evidence report analysis.
UK denies EU accusations of Covid-19 vaccine export bans
The UK and the European Union (EU) are embroiled in a public diplomatic row about Covid-19 vaccine exports.
European Council President Charles Michel claimed the UK and the US were imposing “an outright ban on the export of vaccines or vaccine components produced on their territory”.
VBI Vaccines begins enrolment in Covid-19 vaccine candidate study
VBI Vaccines has commenced enrolment in an adaptive Phase I/II clinical study of its enveloped virus-like particle Covid-19 vaccine candidate, VBI-2902.
The randomised, observer-blind, placebo-controlled study will analyse the safety, tolerability, and immunogenicity of VBI-2902, adjuvanted with aluminum phosphate.
Valo and ImmunoScape identify peptides for coronavirus vaccine development
Valo Therapeutics has partnered with ImmunoScape to identify immunogenic peptides for pan-coronavirus vaccine development. The detected conserved peptide sequences will be applied to adenoviruses to address efficacy problems with existing vaccines against novel Covid-19 variants.
Novartis’ canakinumab fails to meet primary endpoint in lung cancer trial
Novartis has reported that the Phase III CANOPY-2 study of canakinumab (ACZ885) in combination with the chemotherapy agent docetaxel failed to meet the primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer.