Coronavirus Breaking News

Gland Pharma Ltd. announced it will be leveraging its manufacturing capabilities to produce 252 million doses of the Sputnik V COVID-19 vaccine in late 2021. The new agreement with the Russian Direct Investment Fund (RDIF) will utilize Gland Pharma utilizing its Drug Substance and Drug Product facilities at its sites in Hyderabad, India.

Gland Pharma will initially conduct a undertake technology transfer of the drug substance to its manufacturing facilities. Gland Pharma will then undertake drug substances and drug products filling into vials under aseptic conditions. The destinations for these Sputnik V vaccines were not disclosed.

The Sputnik V vaccine has been authorized in about 51 countries globally as of March 15, 2021.

This COVID-19 vaccine, Sputnik V, is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.

On February 2, 2021, The Lancet published a study: Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine, an interim analysis of a randomized controlled phase 3 trial in Russia. This peer-reviewed article concluded the phase 3 trial of Gam-COVID-Vac showed 91.6% efficacy against COVID-19 and was well tolerated in a large cohort.

British Columbia-based SaNOtize Research & Development Corp. announced on March 15, 2021, results of clinical trials indicating that SaNOtize’s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that could prevent transmission of the coronavirus that causes COVID-19, shorten its course, and reduce the severity of symptoms and damage in those already infected.

The majority of the patients in the study had been infected with the UK variant, which is considered a variant of concern.

In a randomized, double-blind, placebo-controlled Phase 2 trial that evaluated 79 confirmed cases of COVID-19, SaNOtize’s NONS early treatment for COVID-19 significantly reduced the level of SARS-CoV-2, including in patients with high viral loads. The average viral log reduction in the first 24 hours was 1.362, which corresponds to a decline of about 95%.

Within 72 hours, the viral load dropped by more than 99%.

There were no adverse health events recorded in the UK trial or in over 7,000 self-administered treatments given in earlier Canadian clinical trials. NONS is not a monoclonal antibody treatment.

SaNOtize Research & Development Corp. is a biotech company based in Vancouver, BC.

England-based AstraZeneca issued a press statement on March 14, 2021, which stated: 'A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and the UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

'So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of March 8, 2021.'

'This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.'

'Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.'

Ann Taylor, Chief Medical Officer, added, “The nature of the pandemic has led to increased attention in individual cases, and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for treating diseases in three therapy areas; Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

The COVID-19 vaccine landscape includes innovative development platforms, with eleven COVID-19 vaccines now authorized globally. As of March 14, 2021, the US Food and Drug Administration (FDA) has authorized three (3) experimental COVID-19 vaccines for use in the USA.

On December 11, 2020, the FDA authorized the experimental Pfizer-BioNTech COVID-19 Vaccine, known as Comirnaty. On December 18th, the FDA authorized Massachusetts-based Moderna's COVID-19 Vaccine. Followed by a third FDA authorization for the Johnson and Johnson Janssen COVID-19 vaccine announced on February 27, 2021.

Furthermore, the CDC recently issued Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines currently Authorized in the USA. And the CDC published updated Frequently Asked Questions about COVID-19 Vaccination on March 12, 2021.

As of March 14, 2021, the U.S. CDC reported over 107 million vaccinations had been administered. There have been 69 million first-dose vaccines administered, and the number of people receiving two vaccine doses had exceeded 37 million. This data indicates the USA leads all countries with COVID-19 vaccine doses administered.

Our World in Data reported China had confirmed about 52.5 million, and the UK has confirmed over 25 million vaccine doses administered.

Travel measures, such as quarantine and diagnostic testing, are designed to reduce the likelihood of SARS-CoV-2 transmission before, during, and after international travel, says the European Centre for Disease Prevention and Control (ECDC).

This ECDC document published on March 12, 2021, summarises the current scientific evidence to support decision-making concerning quarantine and testing of travelers, considering the emergence of SARS-CoV-2 variants of concern (VOC) and the current epidemiological situation in Europe.

As of early March 2021, three VOCs with an important public health impact have already emerged and been described (P.1 first described in Brazil; B.1.351 first described in South Africa, and B.1.1.7 first described in the United Kingdom). New VOCs derived from the previous ones will continue to emerge, be detected, and characterized, says the ECDC.

As of March 12, 2021, the U.S. CDC reported the following number of variant cases in the USA:

• UK B.1.1.7 = 3,701
• South Africa B.1.351 = 108
• Brazil P.1 = 17

The continual investigation of the VOCs is therefore essential to understand their impact on COVID-19 vaccine effectiveness. The ECDC says it will continue monitoring the epidemiological situation, and this guidance will be updated with all relevant evidence accordingly.

The ECDC is an EU agency aimed at strengthening Europe's defenses against infectious diseases.

New Jersey-based Johnson & Johnson (JNJ) announced today that the World Health Organization (WHO) had issued Emergency Use Listing (EUL) for the Janssen COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.

Data from the Phase 3 ENSEMBLE study showed that the Janssen COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

The study data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.

Alex Gorsky, Chairman and CEO at JNJ, stated in a press release, “We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic.”

The EUL procedure streamlines how new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations procurement agencies. The EUL process expedites access to such products in many countries around the world. It is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

“A single-shot COVID-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic,” added Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development at JNJ.

The European Medicines Agency (EMA) human medicines committee (CHMP) announced on March 11, 2021, the launch of a ‘rolling review’ of data on the antibodies bamlanivimab etesemivab being developed by Indiana-based Eli Lilly and Company.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.

The decision to start the rolling review is based on preliminary results from two studies, one looking at the ability of the medicines to treat COVID-19 when combined, the other one when bamlanivimab is used alone. Recent data shows antibody therapy reduced risk of hospitalizations and death by 87%

Bamlanivimab and etesemivab are two monoclonal antibodies with activity against COVID-19.

A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Bamlanivimab and etesemivab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When they attach to the spike protein, the virus cannot enter the body’s cells. Because the antibodies attach to different parts of the protein, using them in combination may have a greater effect than either alone.

Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19.

Bamlanivimab is authorized in the USA to treat mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Indianapolis-based Eli Lilly has for 140 years remained committed to his vision through every aspect of our business and the people we serve, starting with those who take our medicines, and extending to health care professionals, employees, and the communities which we live.