Pharma News February 2021 Updates

BioNTech ramps up production of its COVID – 19 vaccine to meet global demands :

Pharma News February 2021: The German biotechnology firm has recently announced that it would produce over two billion doses of its COVID – 19 vaccines in 2021. The company added that it plans to scale up its manufacturing capacities to meet the booming demand. It also stated that this was around 50 percent higher than the previously expected output that stood at 1.3 billion doses.

BioNTech and Pfizer have collaborated on the development of this mRNA vaccine. This vaccine is called BNT162b, and the vaccine shot depends on the messenger RNA[1] technology. The use of mRNA boosts the body’s immune system, which sped up the development process largely.

Clinical trials with over ten thousand participants have been conducted, and these showed that the vaccine has an efficacy rate of 95 %. The company has also revealed that this vaccine’s success rate in the vulnerable age groups lies at 94 %.

The company’s CEO^[2] has also commented that this vaccine’s immunization effect would last for at least a year. Although this is not yet confirmed, research has been performed to estimate the recovered patients’ antibody levels. This was done to reveal the duration for which the natural protection would last. The results revealed that the recovered patients’ high antibody levels did not have a significant drop for quite some time. Per this, the company believes that this might be the same in the vaccinated individuals.

Several agreements have been signed to deliver millions of doses of this vaccine to various countries. An agreement has also been signed with the European Union for delivering 200 million doses. This is accompanied by an option for an additional 100 million doses.

The company also mentioned that Pfizer’s production facility processes in Puurs, Belgium, have been modified. This has helped bring the company back to the original schedule of vaccine dose delivery to the European Union.

Abbreviation : 1. Ribonucleic acid

Chief Executive Officer

2. Canadian pharma considers importing 50,000 doses of Covishield vaccine from India :

Pharma News February 2021: A private pharma company from Canada has recently contacted the Indian government to secure the Covishield vaccine doses. As per the Indian officials, this was a query and not a final deal.

The unidentified Canadian company discussed with the Indian government regarding the import of over 50,000 doses of the vaccine. This vaccine is developed by Oxford – AstraZeneca in the UK^[1] and manufactured by Serum Institute of India under the Covishield brand.

The Canadian program has already ordered millions of doses of the vaccine from AstraZeneca. But owing to the lack of supplies, this company has decided to secure another consignment separately.

Canada has secured vaccine deals with Pfizer – BioNTech, Moderna, AstraZeneca, Sanofi and GlaxoSmithKline, Johnson & Johnson, and Novovax. These account for over 350 million doses of COVID – 19 vaccines in total.

The vaccination program began in December 2020 in the country but has now come to a standstill due to a deficit of supplies. The program started after emergency authorization was given to Pfizer and Moderna vaccines. The recent lack of supplies was attributed to Pfizer delaying its supplies by ramping up its production plant in Belgium. Another important reason for this is the export controls placed on the vaccines manufactured in certain regions by the European Commission.

AstraZeneca has already sought out the Canadian public health authorities for its vaccine clearance. However, the region from where these will be sourced is yet to be revealed. The shipments from the European Union will be resuming soon. This belief is based on the fact that some shipments have already begun arriving in Canada.

On 2 February 2021, Canada agreed with Novovax to manufacture its vaccine. However, these vials are unlikely to be ready before the end of 2021.

Abbreviation : 1. United Kingdom

Pfizer withdraws the application for the emergency use authorization of its COVID -19 vaccine in India :

Pharma News February 2021: On 5 February 2021, Pfizer claimed that it has withdrawn the application for the EUA^[1] of its COVID – 19 vaccine in India. This company was the first drugmaker to apply for the EUA of its vaccine to the DCGI^[2]. The company held a meeting with India’s drug regulator on 3 February 2021 and finally made this decision.

The company stated that it would resubmit the application in the future after securing the Indian drugs regulator’s additional information. The company’s spokesperson stated that the company was committed to ensuring this vaccine’s use by the Indian government.

The CDSCO^[3]expert committee announced that Pfizer did not produce any plan to generate safety and immunogenicity data in the Indian population. This was one reason behind the company’s decision to withdraw the application. Apart from this, CDSCO also revealed that it has been keeping an eye on the side effects reported abroad post-vaccination using Pfizer’s vaccine.

India started its mass vaccination program on 16 January 2021 following the approval of two COVID -19 vaccines in the country. This includes Covishield and Covaxin. Covishield is developed by Oxford University and locally produced by Serum Institute of India. Covaxin, on the other hand, is indigenously manufactured by Bharat Biotech.

Pfizer – BioNTech’s COVID -19 vaccine was first approved in the UK^[4] on 2 December 2021 after approval from the MHRA^[5]. The country has ordered over 40 million doses of this vaccine to vaccinate its 20 million population.

Following the UK, Bahrain approved the vaccine for emergency use after a thorough analysis of the available data.

Pfizer’s COVID – 19 vaccine must be stored at – 70 degrees Celsius. This extremely low temperature is needed as the vaccine uses synthetic mRNA to induce an immune response.

The company also announced on 2 February 2021 that it expects to generate around $15 billion from the sales of its vaccine. Pfizer currently plans to produce around 2 billion doses of this vaccine in 2021.

Abbreviation :

1. Emergency Use Authorization
2. Drugs Controller General of India
3. Central Drugs Standard Control Organization
4. United Kingdom
5. Medicines and Healthcare Products Regulatory Agency

4. Central government committee approves the indigenous manufacture of Chlorantraniliprole by Natco Pharma :

Pharma News February 2021: Natco Pharma is a generic drugmaker that diversified into agrichemicals around two years ago in 2019. It recently announced that it has received approval for its application regarding Chlorantraniliprole ( CTPR ). This approval was received on 5 February 2021.

The Central Insecticide Board & Registration Committee approved the company’s application on 25 January 2021. This application was submitted to get registration for the indigenous manufacture of CTPR Technical 93.00 % w/w^[1].

CTPR is a broad – spectrum insecticide that is used for better pest management in several crops. This product is the first key product of the company’s Crop Health Sciences Division. The company also claimed that it would be the first indigenous manufacturer to produce this technical product.

Natco also has pending litigation against FMC[2] corporation, a US chemical major company, for the declaration of freedom to use CTPR. It hopes to bring other CTPR based products to India at an affordable cost and ensure their accessibility to all farmers.

CTPR is an active ingredient of certain products manufactured by FMC corporation under the brands Coragen and Ferterra. As per FMC, the sales revenue of products containing CTPR in India is estimated to be around Rs. 1,540 crore in the year 2016.

Based on this data, Natco expects the current market size to be over Rs. 2,000 crore. During the company’s diversification, it invested over Rs. 100 crore to set up a manufacturing plant in Andhra Pradesh. This plant is involved in the making of agrichemical technical and formulation products.

Abbreviation :

1. Weight by weight
2. Food Machinery and Chemical Corporation

5. AstraZeneca receives DCGI’s approval for the use of its Dapagliflozin tablets in chronic kidney disease patients :

Pharma News February 2021: AstraZeneca announced that the DCGI^[1] has given the go – ahead signal for its Dapagliflozin tablets, on 6 February 2021. This tablet was approved by the DCGI for the treatment of chronic kidney disease patients.

The company claimed that it has received the Import and Market permission in Form CT – 20 ( Subsequent New Drug Approval ). This approval was given for Dapagliflozin 10 mg tablets. Dapagliflozin is now approved for the treatment of patients with chronic kidney disease up to stage III. The company plans to launch this product into this new disease are soon and make it accessible to all the nephrologists in India.

This drug was initially approved by the DCGI for the treatment of patients suffering from heart failure with reduced ejection fraction. The company received this approval for this use in July 2020. Apart from this, Dapagliflozin is also used as a diabetic medication in India. It is widely used to lower blood sugar levels in adults with type II diabetes.

Abbreviation : 1. Drugs Controller General of India

References :

2-billion-doses-of-Pfizer-vaccine– Livemint – 2 February 2021
covid19-canadian-pharma-company-plans-to-import-covishield– Hindustan Times – 3 February 2021
pfizer-withdraws-application-for-emergency-use-of-its-covid-19-vaccine-in-india– Livemint – 5 February 2021
natco-pharma-gets-central-panel-nod-for-chlorantraniliprole– The Hindu – 5 February 2021
astrazeneca-s-dapagliflozin-tablets– Business Standard – 6 February 2021