Pfizer Will Seek Emergency-Use Authorization For COVID-19 Vaccine

Drugmaker Pfizer said Tuesday that it plans to apply for emergency-use authorization from the Food and Drug Administration for its COVID-19 vaccine in November, once safety milestones are achieved. 

Pfizer, one of the leaders in the race to develop a vaccine against COVID-19, said the final-stage trial of its vaccine candidate has now enrolled nearly all of the planned 44,000 participants worldwide. Nearly 36,000 had received the second shot of the two-dose vaccine as of Monday. 

Notably, it has expanded enrollment in the trial to include individuals as young as 12 as well as people with chronic stable HIV, hepatitis C and hepatitis B.

It expects to know soon whether or not the vaccine is effective in these populations. Pfizer CEO Albert Bourla had previously said the company expected to know whether its vaccine worked by the end of October.

Pfizer already has contracts with the United States, the European Union and about 10 countries to supply hundreds of millions of doses of the vaccine next year, assuming it wins approval.

The maker of the world's top-selling vaccine, Prevnar 13, for preventing pneumonia and related bacterial diseases, reported net income of $2.2 billion, or 39 cents per share, down from $7.7 billion, or $1.36 per share, in 2019's third quarter.

Excluding one-time items, adjusted income came to $4.1 billion, or 72 cents per share. That beat Wall Street expectations by 2 cents, according to a survey by Zacks Investment Research.

Revenue totaled $12.1 billion, down 4% from $12.7 billion in the year-ago quarter.

Pfizer said it now expects 2020 adjusted earnings per-share of $2.88 to $2.93, tweaked from its July forecast of $2.85 to $2.95. It expects revenue of $48.8 billion to $49.5 billion, narrowed from its previous forecast of $48.6 billion to $50.6 billion.

The biggest U.S. drugmaker by revenue is in the process of spinning off its established products business, which sells mostly off-patent medicines, to combine it with generic drug maker Mylan.

That deal is expected to close by year-end, leaving Pfizer roughly 20% smaller, nimbler and more focused on developing innovative medicines. Pfizer expects to be able to grow revenue at least 6% annually through 2025 as a result of the transformation.

Pfizer shares have decreased 3% since the beginning of the year, while the S&P 500 index has increased slightly more than 5%. The stock has climbed 4% in the last 12 months.