What happens next for Moderna and Pfizer’s coronavirus vaccine candidates



[ad_1]

December will be a crucial month for both Modern (NASDAQ: ARNM) and Pfizer (NYSE: PFE). These leaders in the coronavirus vaccine race have reached the final hurdle. Earlier this week, Moderna applied for emergency use authorization (EUA) for its coronavirus vaccine candidate. Pfizer and its partner BioNTech (NASDAQ: BNTX) asked them about ten days earlier.

In the meantime, nine other programs remain in phase 3 of studies. So even if Moderna and Pfizer cross the finish line with the USA in their hands, that doesn’t mean the race is over. The US Food and Drug Administration (FDA) could grant EUAs to other players in the coming months if their results are solid. Before that, however, a lot can happen. Let’s take a look at the suite of Moderna and Pfizer vaccine candidates.

Person looking at the phone and making notes in the diary book

Image source: Getty Images.

A matter of days

Pfizer is the most advanced from a chronological standpoint. But we are talking about a matter of days. The FDA has called a meeting of its Advisory Committee on Vaccines and Related Biologics (VRBPAC) on December 10 to discuss the investigational vaccine. VRBPAC will meet on December 17 to discuss Moderna’s candidate. These meetings are an opportunity for the panel of experts to weigh in on the potential product. The FDA opens the meetings to the public and broadcasts them live on the agency’s social media.

The companies will present trial data to VRBPAC and answer any questions about the trials and the vaccine candidate. VRBPAC will then advise the FDA on whether the regulator should nod to potential products. But the FDA doesn’t have to follow. The agency’s decision can be made at any time after VRBPAC has issued a notice.

So if the FDA acts quickly in either case, we might expect an EUA for Pfizer and Moderna this month – and just a few days apart.

Suppose the FDA clears the two potential vaccines. Pfizer and Moderna have said they are ready to begin distribution. Pfizer could deliver up to 50 million doses worldwide by the end of the year. In the United States, Pfizer will ship frozen products from distribution centers in Michigan and Wisconsin to vaccination sites. The company expects to get the product to point-of-use within a day or two.

Moderna could produce up to 20 million doses in the United States by the end of the year. Biotech works with Centers for Disease Control and Prevention, Operation Warp Speed ​​and vaccine distributor Mckesson (NYSE: MCK).

A full quarter of turnover

This means Moderna and Pfizer could generate a full quarter of revenue from the coronavirus vaccine by the end of March. Meanwhile, the FDA and regulatory agencies in other countries will continue to review company data for full product approval. An EUA offers companies the opportunity to sell a product before a full review, given the urgent need for it. But the FDA could eventually revoke an EUA or decide not to grant full vaccine approval. So getting the approval will be a crucial step for both players.

Now, how do these upcoming milestones translate into stock price catalysts?

For Pfizer, I would expect a possible EUA and then a possible approval to trigger gains. But vaccine sales figures are unlikely to offer much share movement. This large pharma has a complete portfolio of marketed products; investors will focus on total revenue rather than sales of a single product.

Moderna stocks have more to gain. A possible EUA and eventual approval are sure to increase the stock. This is because Moderna does not have any products on the market yet. The success of the coronavirus vaccination program could be its ticket to short-term income. And speaking of revenue, investors will be keeping an eye on the first quarter of vaccine sales. These results will also offer direction for actions.

While it may appear that the excitement of the coronavirus vaccine is almost over, it is not. Full product approvals, revenue, and the potential for market share gains (or losses) mean we’ll all be talking about – and perhaps investing in – vaccine makers for the foreseeable future.



[ad_2]

Source link