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Staying power:
Novavax Board of Directors in June 2011 (then new CEO
Stanley Erck
in turquoise shirt 2nd from left in back row)
Photo: The Washington Post / via Getty Images
Many hopes rest on him, now the time has come: From February 21, the Novavax corona vaccine is to be vaccinated in Germany.
The EU Medicines Agency EMA approved the vaccine at the end of December, and the Standing Vaccination Commission recommended vaccination in Germany a few days ago.
The clinical studies were successful, and scientists previously gave top marks: the drug is 90 percent effective, just like the coveted mRNA vaccines from Biontech/Pfizer and Moderna, and even stronger against some new virus variants - and with milder and rarer side effects .
Of course, Novavax boss
Stanley Erck
(73) knows that he is late with his vaccine, as he admitted to the “Wall Street Journal” last year.
However, compared to the other four vaccines previously approved in the European Union – in addition to those from Biontech/Pfizer and Moderna, the vaccines from Johnson & Johnson and Astrazeneca are also permitted in the international community – the product has a decisive advantage.
The technology was new when Novavax was founded
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 made of tiny nanolipids, the rapid growth of seed cultures in moth cells or an active ingredient enhancer (adjuvant) made from the bark of a Chilean soap tree.
Protein vaccines themselves, however, have been in use for as long as the company Novavax has existed, 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.
Biontech 2020 was the first approval ever for mRNA technology.
It is true that these vaccines have now proven themselves in tens of millions of applications.
After the extremely rare side effects discovered, physicians do not expect that negative long-term consequences could occur.
But there are still many vaccine skeptics who fear the injection, which is perceived as an experiment.
For them, Novavax as the well-known is a tempting offer, argues in "The Atlantic" the public health expert
Hilda Bastian
, who used to work for the German drug testing agency IQWIG.
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 at pharmaceutical giant Merck & Co., who once refused an offer of cooperation with the start-up.
"I admire her tenacity, her perseverance, her approach of never dying," Pomerantz, now head of biotech company Contrafect, told the Wall Street Journal.
Bowling with the employees
The vaccine is already being used in emerging countries such as Indonesia and the Philippines.
This is probably also where the greatest potential for Novavax lies, as the product can be stored at refrigerator temperatures.
But the vaccine has also been approved in Australia, South Korea and India.
The European Union has ordered around 100 million cans with an option for 100 million more.
So the chances are quite good that Novavax will still achieve commercial success.
It would be the first in the history of the Maryland company, which was founded in 1987.
During Stanley Erck's ten-year tenure alone, the company experienced 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 without any sales success, successes with newly developed vaccines were repeatedly announced, which then came to nothing.
Novavax promised salvation against HIV, Sars, swine flu, Ebola, Mers and more.
Erck, a veteran of the Vietnam War, wasn't always as cautious in his tone as he was in the conversation with the Wall Street Journal.
In 2015, he said that a vaccine against the respiratory virus RSV 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 drug failed the final phase of clinical trials.
The morning after Donald Trump (75) was elected President of the United States, a third of Novavax employees received a dismissal letter.
Another third of the remaining workforce had to leave in 2019 after another RSV study flopped.
Novavax even sold its manufacturing assets to stay afloat and avoided being delisted from the Nasdaq tech exchange,
"I'm a biotech CEO," Stanley Erck dismissed when asked if he had promised too much.
"I admit to being an optimist."
Insiders described the atmosphere at the company, which is based in a sober low-rise building in an industrial park, as casual but unprofessional.
On Fridays, Erck met the whole team for bowling with beer.
In early 2020 there was another meeting at 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 half a year.
And then Corona came.
In January 2021, Erck took the risk of trying the protein vaccine against the novel corona virus instead of concentrating fully on the flu drug.
On April 30 last year, the project NVX-CoV2373 was registered for a clinical study with the US authority FDA - at the same time as that of Biontech, which subsequently marched through to global success.
Novavax, on the other hand, experienced the roller coaster ride of hope and disappointment that also characterizes the company's history in fast motion.
Billions injected by Trump and Gates
First, the virus gene sample ordered in China did not arrive due to canceled flights.
Then there were no production partners - at times Novavax had to rely on the company Emergent Biosolutions of the German founder
Fuad El-Hibri
(63), whose Baltimore factory later mixed active ingredients from Johnson & Johnson and Astrazeneca, which is why it has now been shut down since April 2021 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 persons jumped out because they didn't want to have just been injected with a placebo when in doubt.
Novavax responded with a new study design, which again took time.
Most recently, the company reported a month-long delay due to a lack of raw materials - and growing losses the longer the development takes.
On the credit side are two billion dollars in cash.
Novavax owes this primarily to the American government.
Trump's Warp Speed vaccine operation pledged $1.6 billion in July 2020, the program's largest amount to date, even more than Moderna's successful mRNA project, which was largely run by government institutes.
The New York Times reported that two of Barda's decision-makers had previously led Novavax's vaccine development.
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 up a floor.
Of course, the company uses its connections,
, but everything went smoothly.
The most important door opener was probably the connection to the Gates Foundation and the non-profit organization CEPI it launched, both of which had previously supported Novavax on other vaccine projects.
CEPI boss
Richard Hatchett
decided on Novavax back in February 2020 and pledged $388 million before money even flowed from the state.
In this way, the company also got a major order from the Covax initiative for developing countries – and an appearance in the White House for the vaccination summit with Trump.
"Frankly, we need money," Stanley Erck's March 2, 2020 post is noted in the transcripts.
With these words he should have ensured that after 34 years Novavax is about to shake off the reputation of the eternal failure.
