Moderna, Novavax Hope for Early Launch of Covid-19 Vaccine This Year – Barron’s

U.S. vaccine makers say that the Food and Drug Administrations delay in designing this falls Covid-19 vaccines shouldnt push back the rollout of the shots, amid rapid shifts in the genetic makeup of the virus.

Vaccine makers Moderna and Novavax are hoping for an August rollout this year, earlier than last years late September debut of updated shots. Moderna CEO Stphane Bancel recently told Barrons that launching the shots in August instead of September could add three million doses to the market.

Sales of Pfizer , Moderna, and Novavax s shots fell far below expectations last year, setting off steep stock slides for all three of the companies. A better showing in the fall of 2024 could boost all three of the drugmakers.

The programs ran into a hiccup earlier this month, though, when the FDA delayed a May 16 meeting of its outside advisors to decide which strain of the virus the updated shots should address. As with the annual flu shots, Covid-19 shots are now tweaked each year to target the version of the virus currently circulating.

The virus that causes Covid-19 is a slippery target, and in recent weeks it has begun to change again. The FDA now plans to hold its strain selection meeting on June 5, a date thats still earlier than last years meeting, which was held June 15. In comments to Barrons on Monday, vaccine manufacturers seemed unfazed by the delay.

Advertisement - Scroll to Continue

A Moderna spokesperson said an August launch is still feasible, regardless of which strain the FDAs advisors choose. A Novavax spokesperson said that the later meeting date will not affect Novavaxs ability to deliver a Covid-19 vaccine this fall. A Pfizer spokesperson said that the company is aware of the date change, and that it is focused on working with the FDA.

The FDA, in a social media post on May 7, said it was delaying the meeting to allow more time to collect data to inform the committees recommendation. The postponement appeared to reflect the rapid changes in the makeup of the variant landscape in the U.S.

The strain that dominated in the U.S. since January of this year, known as JN.1, has begun to lose ground in recent weeks. The Centers for Disease Control and Prevention estimates that in the two-week period ending May 11, JN.1s prevalence had fallen to just 15%, as it has been surpassed by a number of its descendants. Chief among those descendants is the strain known as KP.2, which the CDC expects to have risen to 28.2% in the period ending May 11, quickly rising from just 1.4% in mid-March.

Advertisement - Scroll to Continue

The new variants replacing JN.1, including KP.2, share a handful of mutations scientists are calling FLiRT, which seem to give them an advantage over JN.1. CDC wastewater tracking shows that viral activity level for Covid-19 is currently minimal in the U.S.

Other global regulatory authorities have already made their decisions on which Covid strain to target. The World Health Organization said in late April said its advisory group recommended that new Covid-19 vaccines target JN.1. The European Medicines Agency made the same recommendation.

In an interview with Barrons in early May, Modernas Bancel said that his company had already begun manufacturing components for a shot targeting JN.1, but that the company was also preparing to make shots targeting one of the JN.1 descendants if necessary. We want to be a partner of the FDA from a public health standpoint, he said. They decide which strain goes into a vaccine and we will execute.

Advertisement - Scroll to Continue

Novavax, for its part, said at an earnings presentation May 10 that its also manufacturing a JN.1 vaccine, and that tests in non-human primates show that it induces an immune response against both JN.1 and the JN.1 descendant strains.

We have data which demonstrates good cross-reactivity between our JN.1 vaccine and KP.2, which is a JN.1 variant, the Novavax spokesperson said Monday. These data provide us confidence our vaccine has utility against the currently circulating strains.

Pfizer has not discussed its manufacturing plans for the fall Covid-19 shot.

Advertisement - Scroll to Continue

The question looming over the companies is how large the Covid-19 vaccine market will be this year, and whether an earlier launch will help with uptake. If the FDA and CDC can pull August off, I think the market should grow this year versus last year, Bancel told Barrons in early May.

Moderna, which so far is a pure play on Covid-19, saw its vaccine revenue fall 64% last year, to $6.7 billion, as demand for the vaccines evaporated.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

See the original post here:

Moderna, Novavax Hope for Early Launch of Covid-19 Vaccine This Year - Barron's