Novavax reviews extra delays for its Covid-19 vaccine

Written by Katie Thomas
Novavax, one of many first gamers within the race to vaccinate the world in opposition to COVID, delivered disheartening information Monday, saying that its extremely protecting vaccine wouldn’t be licensed within the United States or Britain till no less than July, and that it will not attain peak manufacturing till the tip of the yr.
The delays, introduced throughout an earnings name with buyers, are the most recent setback for the little-known Maryland firm, which was granted as much as $1.6 billion from the U.S. federal authorities final yr and whose product has proven strong ends in scientific trials. Despite these wins, the corporate has struggled to display that it will probably ship on its promise to provide the world with 2 billion doses this yr. Novavax has by no means introduced a vaccine to market in its 34-year historical past.
On the decision, the corporate’s president and chief government, Stanley C. Erck, mentioned that the regulatory and manufacturing hurdles inflicting the delay have now been resolved. “Nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel,” he mentioned.
Investors didn’t seem to agree: By Tuesday morning, the corporate’s inventory had fallen to $133.86, down practically 17%, though it rebounded considerably later within the day.
“I don’t see a lot going well for them at this point,” mentioned Rob Smith, the managing director of Capital Alpha Partners, an funding analysis agency.
The firm’s delay is unlikely to have an effect on rich international locations just like the United States, which is flush with vaccines from Moderna, Pfizer-BioNTech and Johnson & Johnson.
But it’s more likely to have important repercussions for the remainder of the world, on condition that simply final week, Novavax finalized a take care of Gavi, a public-private world vaccine partnership, to provide 1.1 billion doses of its shot to low- and middle-income international locations. Novavax has struck different offers with international locations like South Korea, Japan and Australia, and has arrange agreements with eight manufacturing crops all over the world.
In January, the corporate estimated that it will hit its full manufacturing capability of 150 million doses a month by the center of this yr, a prediction it later revised after dealing with a scarcity of provides like filters and the enormous single-use luggage which can be utilized in vaccine manufacturing. On Monday, the corporate delayed its estimate once more, saying it anticipated to succeed in manufacturing of 100 million doses a month by the tip of the third quarter, and to make 150 million a month by the fourth quarter.
One of its main manufacturing companions, the Serum Institute in India, has confronted its personal manufacturing and geopolitical challenges. A fireplace on the facility earlier this yr decreased its capability, and in April, Serum’s chief government, Adar Poonawalla, known as out the United States for proscribing entry to uncooked vaccine substances. And although Novavax’s take care of Serum is meant to provide the remainder of the world by way of its association with Gavi, the Indian authorities has banned exports of vaccines from the nation because it struggles with a lethal second wave of COVID-19.
“Serum is the backbone of vaccine supply to the world,” mentioned Andrea Taylor, assistant director of the Duke Global Health Innovation Center, which is monitoring world vaccine offers. “I think particularly for countries in South and Southeast Asia, as well as countries in Africa, it is hard to overstate the impact that this is having.”
Regulatory hurdles have additionally set Novavax again. On Monday, firm executives mentioned {that a} now-resolved subject with an “assay” — a take a look at that was wanted to verify that their product could be persistently manufactured at business scale throughout a number of manufacturing crops — was delaying regulatory approvals all over the world, and that international locations like Britain and the United States wouldn’t grant authorization till no less than July. Company officers as soon as mentioned they hoped to achieve authorization for his or her vaccine in April.
The delay is especially hanging in Britain, since Novavax reported optimistic outcomes of its scientific trial there in January.
British officers persuaded Novavax to arrange a trial there final yr partially by promising velocity in scientific improvement and regulatory approval. But time is operating out: About two-thirds of British adults have acquired a primary dose of a coronavirus vaccine, most made by AstraZeneca, and each grownup is predicted to be supplied one by the tip of July.
The vaccine’s function in Britain relies upon partially on how shortly Novavax can begin distributing its shot. A British manufacturing unit making the vaccines has mentioned that it will be prepared by the summer season. The nation has just lately turned away from the AstraZeneca shot in youthful individuals due to the chance of very uncommon blood clots, leaving room for Novavax to be an alternate for individuals underneath 40.
The nation can also be finding out the results of administering a second dose of the Novavax vaccine in individuals who have already acquired a primary dose from both Pfizer or AstraZeneca.
In the United States, Novavax’s setback casts new gentle on its huge take care of the U.S. authorities. As just lately as 2019, the corporate was on the verge of closing after a serious trial failure for one more vaccine, and it was compelled to dump its manufacturing facility to lift cash.
Last yr, the Trump administration positioned a serious wager on the tiny firm as a part of its Operation Warp Speed challenge, signing a $1.6 billion contract for supply of 110 million doses by early this yr. In April, the overall quantity of the deal was elevated to $1.75 billion, in accordance with Novavax’s monetary filings. The firm’s giant trial within the United States and Mexico has nonetheless not been accomplished, though executives mentioned Monday that they anticipated outcomes from that research “in a few weeks.”
Novavax officers mentioned they now didn’t count on to ship these doses till the tip of this yr or early 2022. A spokesperson for Novavax mentioned there was no penalty for later supply in its contract with the U.S. authorities.
Novavax’s spotty monitor report doesn’t provide confidence that it will probably rise to the problem of manufacturing billions of doses, mentioned Les Funtleyder, a well being care portfolio supervisor at E Squared Capital Management who invests in home and rising markets. “It seems they were really unprepared for a challenge of this magnitude,” he mentioned.
Recent information of inner turnover — such because the departure final month of Novavax’s chief monetary officer, 5 months after taking the function, for private causes — doesn’t assist, Funtleyder mentioned. “It’s a bad look,” he mentioned.
But even when it has a difficult path as a latecomer, Novavax’s vaccine may fill vital gaps, some consultants mentioned. In the United States, it might be used as a booster shot to shore up waning immunity, or the Biden administration may select to donate the vaccine to different needy international locations, because it has with its unused provide of AstraZeneca doses.
Novavax has mentioned it’s creating a brand new model of its vaccine to deal with the variant circulating in South Africa. And it just lately introduced it will start finding out the shot in kids older than 12, in an effort to catch as much as Moderna and Pfizer, which have already examined their merchandise in that age group.
The vaccine may also be saved at regular refrigeration temperatures, with out the freezing temperatures required by Pfizer and Moderna’s vaccines.
By the tip of 2021 there’ll nonetheless be an amazing want for secure and efficient vaccines that may journey nicely,” mentioned Taylor, of Duke University. “Novavax looks like it can fit that description.”
Dr. Saad B. Omer, the director of the Yale Institute for Global Health, famous that when considerations have been raised over the Johnson & Johnson and AstraZeneca vaccines due to hyperlinks to blood clots, international locations with a number of vaccines obtainable have been in a position to swap to different choices.
“It’s good to hedge our bets,” he mentioned. “If we want to avoid, for example, body blow after body blow to low-income countries in many parts of the world that has an impact on everyone, we need to vaccinate a huge chunk of the world.”