Trials to continue.

Trials to continue.

Pfizer to seek emergency approval for vaccine

Pfizer's dash to the finish line has broken all vaccine development speed records

Agency Report | New York | 20 November, 2020 | 11:00 PM

Pfizer announces that it is moving ahead with its request of asking the US regulators to allow emergency use of its Covid-19 vaccine, which has shown 95 per cent efficacy in a totality of two data sets released in the last 10 days.

Unless some nasty surprises turn up, Pfizer’s action on Friday could be the first step towards vaccinating the most vulnerable Americans by December end.

Pfizer and another US company, Moderna, have broken all vaccine development speed records in their race for a cure over the last nine months.

US regulators are standing by for the approval process while coronavirus cases are surging to record levels across all the 50 states.

The Vaccines and Related Biological Products Advisory Committee in the US Food and Drug Administration is a key player in how this process rolls along.

Pfizer’s submission also includes safety data on approximately 100 children aged 12-15 years.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech expect to produce a total of 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. US regulators hope to have 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.
The chief of the Trump administration’s Operation Warp Speed vaccine programme says all systems are ready to ensure the vaccines get to states as soon as they figure out their distribution plan.

Seen purely from a clock time perspective, Pfizer’s dash to the finish line has broken all vaccine development speed records, and on a totally new technology platform called mRNA – which has no benchmarks yet.

The coronavirus itself isn’t there inside the mRNA vaccine. Instead, it is embedded with a piece of genetic code that trains our bodies to recognize imminent enemy action from the spike protein on the surface of the virus. When the mRNA enters our cells, it begins to spew copies of the coronavirus’ spike protein. That prompts the immune system to churn out antibodies against the virus. In virology, generating neutralising antibodies is a good surrogate of our bodies’ ability to protect from sickness.

Below is a timeline of Pfizer’s run up to this historic moment:

March 17: Pfizer and BioNTech announce plans to develop a Covid-19 vaccine using BioNTech’s technology platform.

April 29: Testing of four vaccine candidates begins with volunteers in Germany. Five other countries are part of the testing pool.

May 5: Testing expands to include the US.

July 1: One of four vaccine candidates appears to rev up the immune system, is well tolerated.

July 22: Trump administration agrees to buy 100 million vaccine doses, with an option for 500 million more.

July 27: Late-stage testing begins for 30,000 volunteers.

September 8: CEOs of 9 pharma giants, including Pfizer and BioNTech, pledge they will not be rushed by politics or extraneous factors.

November 8: Pfizer receives data from independent trial monitors who analyse test results.

November 9: Pfizer announces the vaccine appears to be about 90 per cent effective, based on 94 infections in a pool of more than 43,000 volunteers.

November 18: Pfizer and BioNTech release a second batch of interim results saying their two-dose coronavirus vaccine candidate is 95 per cent effective and also protects the most vulnerable people in older age groups from the risk of dying from the virus.

Nov 20: Pfizer announces intent to submit application to US regulators for emergency use authorisation. (IANS)