• Pfizer and its partner BioNTech have submitted their report seeking early approvals from FDA for its Covid-19 vaccine
  • The company has also started with its submissions in other countries such as Australia, Canada, Europe, Japan and the UK
  • Pfizer is plans to produce about 50 million doses this year and up to 1.3 billion doses by the end of next year

 

Pfizer Inc and its German partner  BioNTech have applied to health regulators in the US seeking approval for emergency use of its Covid-19 vaccine, which has shown 95% effectiveness in preventing Covid-19 with no major safety issues a few days ago. The emergency use authorization is the first-of-its-kind application which was submitted to the Food and Drug Administration (FDA).   

The unprecedented crisis has led to the development of over 150 Covid-19 vaccine candidates across the world. Of these, 44 are undergoing clinical trials and 11 are in late-stage testing. Among the various candidates under trial, the ones from Moderna and Pfizer are leading the race.  On Friday, BioNTech and Pfizer while applying for EUA of BNT162b2, their mRNA coronavirus vaccine candidate against SARS-CoV-2, Pfizer said that the safety milestone required by the FDA has been achieved. 

The company has actively started submitting applications to regulatory authorities worldwide such as the EMA and the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, and intends to submit to other agencies in the near future. 

Chairman and CEO Dr. Albert Bourla said that the company was working relentlessly to deliver a safe and effective vaccine. Filing for approval was an important milestone in its journey to deliver a vaccine to the world, he added. It was also looking forward to the upcoming Vaccines and Related Biological Products Advisory Committee’s discussion.

The pharma companies’ volunteers and investigative site staff have been a part of the study for achieving the most important milestone in their efforts to address the global crisis.

BioNTech’s MD, CEO and co-founder Ugur Sahin also reiterated his intention to continue working with global regulatory agencies to empower the rapid distribution of the vaccine worldwide. 

 

What is the EUA Program?

The Emergency Use Authorization is a program of the US FDA that permits the pharma companies to seek an early permission in case of an unprecedented situation like the pandemic.  Safety data and supporting information are provided by the company to the FDA as a process. On Friday, the FDA said it would hold a meeting of the advisory committee on 10 December.

 

Phase 3 Trial Details

Last week, the pharma company had announced that its vaccine had shown an efficacy rate of 95 per cent in the final analysis of the late-stage clinical trials. 

Based on this result, the US pharma major and its German partner have submitted their report for the authorization. 

In the third phase, the trial was conducted on both types of participants -- who were or were not infected with the disease.  Following which, the participants were tracked for two months.

No serious safety concerns related to the vaccine study have been reported by the Data Monitoring Committee (DMC) till date.

 

How Long Will The Distribution Take?

Distribution of the Pfizer vaccine candidate is expected to begin within hours of its authorization.  People who are at high risk of contracting the virus will be provided with the first doses of the vaccine, which is expected to be rolled out by the next month.

Pfizer is utilising its in-house capabilities to increase the manufacturing and distribution of the vaccine rapidly to different parts of the US and Europe, without compromising on quality. 

The company already has expertise in cold-chain shipping.  The required infrastructure to supply the vaccine globally has also been established, enabling the storage of vaccine up to a period of six months.

Temperature-controlled shippers (-70°C ±10°C) designed particularly for storing (up to 15 days) and transporting Pfizer’s vaccine have been developed by the company. Moreover, GPS-enabled thermal sensors have been installed in each shipper to keep a track of the location and temperature. 

Finally, it is a good news for the global healthcare sector. Pfizer’s vaccine has been found to be 95 per cent effective and the company’s recent EUA has further raised hopes for the people. AstraZeneca PLC (LON: AZN) might be next in the line to release its trials data soon. Further, Johnson & Johnson has also said that it on track to deliver its vaccine. It has got approval to conduct phase III trials in Spain. 

 

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