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Perseverance:
Board of Directors of Novavax in June 2011 (the then new boss
Stanley Erck
in a turquoise shirt 2nd from left in the back row)
Photo: The Washington Post / via Getty Images
Don't do anything wrong now, just don't make too much promises. The corona vaccine from Novavax has not yet been approved, even if the clinical studies are already available, now also scientifically assessed with top marks: The agent is 90 percent effective, as are the coveted mRNA vaccines from Biontech and Moderna, even against some new virus variants even stronger - and with milder and rarer side effects. Around 40 million cans have already been finished. Actually, it could start now, but Novavax boss
Stanley Erck
(73)
is reluctant to talk
to the "Wall Street Journal": "We know that we are late." After all, "almost all of the greatest challenges have now been overcome and we can see the light clearly at the end of the tunnel".
Approval in the USA and the EU, which is expected for the second quarter by May, is now to be applied for in the third quarter that has just begun. Then another 30 days of testing the production processes can be expected, says Erck. "At least in the foreseeable future, we will achieve more in other countries." Around the end of September, the first people could be vaccinated through the global Covax initiative, to which Novavax has promised 1.1 billion vaccine doses. Countries such as Japan, Australia, New Zealand and Canada also rely on the agent. For Europe, whose drug authority EMA has been testing the Novavax substance since February, it would be corona drug number five if the German company Curevac does not get away with its weak data. As a precaution, the contract for 110 million cans reserved for the EU has not yet been signed.
The really big profit, as it could be read in the stock market price at the beginning of the year, shouldn't be for Novavax without lucrative sales in the west. But at least the chances are pretty good that it will be finished just in time to even achieve commercial success. It would be the first in the history of the Maryland company, founded in 1987. In Erck's ten-year tenure alone, the company has seen unprecedented ups and downs, including real near-death experiences. After an earlier episode, when the company tried estrogen ointments or prenatal vitamins instead of vaccines, even without sales success, successes with newly developed vaccines were repeatedly announced, but nothing came of them. Against HIV, Sars, swine flu, Ebola,Novavax promised rescue for Mers and more.
Bowling with the staff
Erck, a veteran of the Vietnam War, was not always as cautious in his tone as he is today.
About a vaccine against the respiratory virus RSV in 2015 he announced that it would be "the best-selling vaccine in the history of vaccines in terms of sales."
The stock market value doubled immediately, but a year later the product failed the final phase of clinical trials.
The morning after Donald Trump was elected US President, a third of Novavax employees received a discharge letter.
Another third of the remaining workforce had to leave in 2019 after another RSV study flopped.
Novavax even sold its manufacturing facilities to stay afloat and avoided being kicked out of the Nasdaq technology exchange by merging 20 shares into one.
"I'm the CEO of Biotech," said Stanley Erck, wiping away the question of whether he had over-promised. "I admit to being an optimist." Insiders described the atmosphere of the company, which is based in a sober low-rise building in an industrial park, as relaxed but unprofessional. On Fridays, Erck met the whole team for bowling with beer. At the beginning of 2020 there was another meeting in a local bar, where the Novavax people discussed where they could still find jobs. They had another hope in the pipeline, this time against the flu, but at best they still had money for six months.
And then Corona came.
In January Erck took the risk of trying the protein vaccine against the novel coronavirus instead of concentrating fully on the flu drug.
On April 30, the NVX-CoV2373 project was registered for a clinical study with the US FDA - at the same time as that of Biontech, which then marched through to global success.
Novavax, on the other hand, experienced the roller coaster ride of hope and disappointment again in fast motion, which also shapes the company's history.
Billion injections from Trump and Gates
At first, the virus gene sample ordered in China did not arrive due to canceled flights.
Then production partners dropped out - at times Novavax relied on the company Emergent Biosolutions of the German founder
Fuad El-Hibri
(63), whose factory in Baltimore later mixed active ingredients from Johnson & Johnson and Astrazeneca, which is why it has now been shut down since April and at least 75 million vaccine doses had to be destroyed at the behest of the authorities. This delayed the study. When it started, other vaccines were already on the market and 5,000 test subjects jumped off because, if in doubt, they did not just want to have injected a placebo. Novavax responded by redesigning the study, which again cost time. Most recently, the company reported a month-long delay due to a lack of raw materials - and increasing losses the longer the development takes.
The plus side is $ 2 billion in cash. Novavax owes this primarily to the American government. Trump's vaccine operation "Warp Speed" pledged 1.6 billion dollars in July 2020, the largest sum of the program to date, even more than for Moderna's successful mRNA project, which is largely run by state institutes. The New York Times reported that two of the decision makers at the Barda biotech agency had previously directed the vaccine development at Novavax. One of them, Rick Bright, refused a meeting with Novavax boss Erck as unethical and filed a whistleblower complaint, but then lost his job - and Erck got his appointment one floor up. Of course, the company uses its connections, explained top manager John Trizzino,but everything went smoothly.
The most important door opener was probably the connection to the Gates Foundation and the non-profit organization CEPI that it initiated, both of which had previously supported Novavax in other vaccine projects.
CEPI boss Richard Hatchett decided in favor of Novavax back in February and pledged $ 388 million before the state received any money.
This is how the company also received the major order from the Covax initiative for developing countries - and an appearance in the White House at the vaccination summit with Trump.
"Frankly, we need money," Stanley Erck's March 2, 2020 entry is noted in the minutes.
With these words, he is likely to have ensured that after 34 years Novavax is about to shake off the reputation of the eternal failure.
The technology was new when Novavax was founded
A decisive advantage could turn out to be that the Novavax method is not as new as the company name ("nova" for new and "vax" for vaccine) suggests. It is a protein vaccine in which, instead of the complete virus, only protein molecules - in this case the spike protein of the coronavirus as a target for the immune system - are injected into the body. Novavax uses some innovative approaches, such as the shell of tiny nanolipids, the rapid cultivation of the inoculation cultures in moth cells or an active ingredient enhancer (adjuvant) from the bark of a Chilean soap tree.
Protein vaccines themselves have been in use for as long as the Novavax company has been around, for example against hepatitis B, shingles or whooping cough. The other Covid-19 vaccines, on the other hand, use newer techniques: vector vaccines such as those from Astrazeneca and Johnson & Johnson or the Russian Sputnik-V were first approved against Ebola in 2019. In 2020, Biontech was the first ever approval for mRNA technology.
It is true that these vaccines have now proven themselves in tens of millions of uses. After the extremely rare side effects discovered as a result, doctors do not expect that negative long-term consequences could occur. But there are still many vaccine skeptics who are afraid of the syringe, which is perceived as an experiment. For them, Novavax, the well-known, is a tempting offer, argues the public health expert
Hilda Bastian
, who used to work for the German drug testing agency IQWIG,
in "The Atlantic"
. Together with the high effectiveness and the weak side effects, their conclusion is: "This is currently the best vaccine against Covid-19 that we have."
Novavax also received praise from
Roger Pomerantz
, a former top manager of the pharmaceutical giant Merck & Co., who once refused to offer a collaboration with the start-up.
"I admire their tenacity, their perseverance, their approach to never die," said Pomerantz, now head of the biotech company Contrafect, the "Wall Street Journal".
"But in the end we have to see the vaccines too."
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