If Moderna moves to file for an emergency use authorisation shortly after the first interim results, the Food and Drug Administration (FDA) may take a few weeks to assess the application before making a decision on it in December
The study will recruit 160 people aged from 20 to 85, the firms said in a statement. Earlier, they had agreed to supply Japan with 120 million doses of their experimental coronavirus vaccine in the first half of 2021.
The US Food and Drug Administration has said it wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
A letter which was obtained by Bloomberg Law and verified by six signatories, was sent on September 25 following the reports that Pfizer’s COVID-19 vaccine clinical trial will yield conclusive results in October which puts the company ahead of Moderna and AstraZeneca in the race of the vaccine.
In recent weeks, Pfizer has said it should know by the end of October whether the vaccine, developed together with Germany's BioNTech SE, is safe and effective. If the vaccine is shown to work by then, Pfizer has said it would quickly seek regulatory approval. It has not said what data it would use.
Supply deals have already been agreed for 5.303 billion doses, of which 2.728 billion (51 percent) have been bought by developed countries including the UK, US, Australia, Hong Kong & Macau, Japan, Switzerland and Israel, as well as the European Union
Pfizer expects “conclusive data” by October-end and promised to make public all its safety and efficacy data in case of emergency authorisation for vaccine
According to Pfizer CEO Albert Bourla, the company’s study will show if there is a “good chance if the product works” by October-end, distribution would depend on license issuances from regulators such as the FDA
The initial target figure for the trial was up to 30,000 participants, which the companies said they expect to reach by next week.
The companies would pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes, the Journal report said, citing the draft of a joint statement that is still being finalized.
Though the negative bias is expected in the short term but stock-specific opportunities are likely to keep the traders in high spirits.
The US drugmaker would provide contract manufacturing services at its facility in Kansas to produce the drug.
The companies said, assuming success of the vaccine in clinical studies, they are on track to seek regulatory review for the vaccine as early as October.
The company had posted a net profit of Rs 112.81 crore for the corresponding period of the previous fiscal, Pfizer Ltd said in a BSE filing.
The Pfizer deal at roughly $2 billion deal translates into per dose price of $20. Competitors will, therefore, be forced to offer their coronavirus vaccine in a similar price range
The agreement is part of President Donald Trump's Operation Warp Speed vaccine program, under which multiple COVID-19 vaccines are being developed simultaneously.
The companies said the data also demonstrated an induction of high level of T-cell responses against the novel coronavirus.
ICICI Direct is bullish on Pfizer recommended buy rating on the stock with a target price of Rs 4740 in its research report dated July 07, 2020.
Britain had secured 30 million doses of the experimental BioNTech/Pfizer vaccine, and a deal in principle for 60 million doses of the Valneva vaccine, with an option of 40 million more doses if it was proven to be safe, effective and suitable, the ministry said.
The candidates, BNT162b1 and BNT162b2, are the most advanced of at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany.
The drug is one of 17 being tested on humans in a frantic global race to find a vaccine the world is counting on to end a pandemic that has infected 10.5 million people and killed more than half a million so far.
ICICI Securities is bullish on Pfizer recommended buy rating on the stock with a target price of Rs 4705 in its research report dated June 15, 2020.
The company said the board has recommended a final dividend of Rs 10 per share for the financial year ended March 31, 2020.