Pfizer and BioNTech’s vaccine reaches the last stages of human trials :
Pharma News – 30 July: Pfizer and BioNTech have been proactive in their search for a Covid-19 vaccine. The initial stages of the clinical trial of their lead Covid-19 vaccine have shown promising results. Following this, the companies have announced that the beginning of a pivotal global study. This announcement was made on 27 July 2020.
This study will comprise the phase 2/3 of the clinical trials and is expected to include around 30,000 participants. It will be conducted in 120 sites globally especially in the regions where the caseloads are high.
The vaccine candidate that will be tested is called BNT162b2. It uses the chemical messenger RNA to aid in the recognition by the immune system.
The drug firms plan to submit the vaccine for regulatory approval by October 2020. The companies however claim that this is possible only after successful completion of the clinical trials. Around 100 million doses of this vaccine will be ready by the end of 2020. Another 1.3 billion doses of this vaccine are expected to be ready by the end of 2021.
The drugmakers’ claim that two doses of the vaccine will be given to boost the patient’s immunity. The initial 100 million doses can, therefore, immunize 50 million people.
Around 150 vaccines are currently being developed for Covid-19. This coronavirus had claimed the lives of around 650,000 people globally.
On 27 July 2020, Moderna Inc. launched a late-stage clinical trial for its vaccine candidate. This study will include around 30,000 subjects.
The Hetero Group has received DCGI’s approval for marketing Favivir in India:
Pharma News – 30 July: The Drugs Controller General of India (DCGI) has approved the generic version of Favipiravir that is being marketed by Hetero labs. This generic version is called ‘Favivir’ and is used in the treatment of mild to moderate Covid-19 patients.
Favivir is priced at Rs.59 per tablet and is being marketed by Hetero Healthcare. This drug will be sold on prescription in all retail outlets and hospital pharmacies across India.
The drug firm claimed that the manufacturing premise is approved by stringent regulatory bodies like the USFDA[1] and the EU[2].
It is to be noted that Favivir is the second drug developed by Hetero pharma following Covifor. Covifor is the generic version of Remdesivir injection. It is administered intravenously and used in the treatment of severe Covid-19 patients. The manufacture of Covifor is possible only after receiving a license from Gilead Sciences.
Hetero pharma has 36 manufacturing facilities across the globe. The portfolio of this company includes around 300 therapeutic products that belong to various categories like diabetes, immunology, oncology, cardiovascular, neurology, hepatology and ophthalmology among others. This drug firm has established its presence in around 126 countries across the globe.
Abbreviation: 1. United States Food and Drug Administration
2.European Union
3.Roche’s Actemra fails in the late-stage clinical trial conducted on Covid-19 patients:
Pharma News – 30 July: Actemra/RoActemra is a drug developed by Roche for treating rheumatoid arthritis. The drug firm had repurposed this drug for treating severe Covid-19 related pneumonia. Though the results of the initial stages of the clinical trials showed promising results, the drug failed at the later stages. This was announced by the company on 29 July 2020.
The late-stage trial was initiated in March 2020 and include 330 patients. This was called the COVACTA trial. The COVACTA trial proved to be unsuccessful as it did not reduce the mortality rate and the Covid-19 associated pneumonia.
An Italian study had also revealed the ineffectiveness of Actemra in patients with early-stage Covid-19 pneumonia.
The company has also collaborated with Gilead Sciences Inc. to check the effectiveness of combining Actemra and Remdesivir. Roche has announced that it would not apply for regulatory approval of Actemra.
The European Commission had already struck a deal with Roche to secure supplies of Actemra. However, the negative results of the trial have put this deal on standstill.
It was also revealed that there was no difference in mortality rates in the patients who were administered Actemra and control. This conclusion was deduced after four weeks of the study.
Around 150 companies are currently on the hunt for a Covid-19 vaccine. This pandemic has claimed the lives of around 660,000 people across the globe.
Despite this disheartening news, the trial of other drugs is on full swing. A member of the RECOVERY trial team has claimed that the use of tocilizumab for treating severe patients is still onboard. This trial is being conducted in Britain.
4. Increasing demand for Remdesivir forces the Centre to pressurize Indian pharma:
Pharma News – 30 July: Remedesivir is an antiviral drug that was developed by Gilead Sciences Inc. It was originally developed for Ebola but has now been repurposed for Covid-19.
Gilead has tied up with Indian pharma companies for the marketing and sale of this antiviral drug in India. The drug firms that have been licensed include Cipla, Hetero Drugs, Mylan, Jubilant Life Sciences, Dr.Reddy’s Laboratories and Cadila Healthcare.
Among these, only three companies have received the DCGI’s[1] approval for marketing Remdesivir in India. This includes Hetero, Cipla and Mylan. The price of the generic version of Remdesivir currently stands between Rs.4000 per vial to Rs.5000 per vial.
Since this drug has a shelf life of 3 months, the companies are refraining from stocking up on them. This is because producing large volumes at a time is filled with risks.
The process of producing this injectable is complex and involves 20 different steps. Around 14 active pharmaceutical ingredients are utilized in the manufacturing process. All these difficulties make manufacturing a time-consuming and expensive process.
Owing to an increase in the caseloads across the country, the DCGI approved the use of Remdesivir under emergency use authorization. However, there has been a shortage of these critical medications owing to the surge in the number of cases. To meet the increased demand, the Centre has begun to pressurize the companies to ramp up the production of Remdesivir.
In response to this, pharma companies have promised the supply of around 815,000 doses of Remdesivir for August 2020. This is higher than the scheduled 365000 doses for July 2020.
The shortage of this drug has resulted in it being sold at six to seven times its original price at the black market. The government is, however, taking strict action to abolish this black-market trading.
The prices of Remdesivir are expected to drop below Rs.4000 as other pharma companies have also received the DCGI’s approval. This is because many are speculating that Cadila and Dr.Reddy’s will price their generic version at even lower prices for surviving the ongoing price war.
Abbreviation: 1. Drugs Controller General of India
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References:
- [1] – Economic times – 28 July 2020
- [2] – Economic times – 29 July 2020
- [3] – Reuters – 29 July 2020
- [4] – Business Standard – 30 July 2020
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