Reuters Article on Novavax: a Rebuttal

 [disclosure: I own shares in Novavax]

The protein-based vaccine by Novavax is about to become the gold standard covid vaccine: proven to be highly efficacious and better tolerated than existing options with 3-shot and ease of multiplexing making it ideally suited for fighting variants along with flu in the future.

Unfortunately, Nuvaxovid (aka Covovax) has not been widely available as manufacturing a protein is not as straightforward as making an mRNA-LNP particle.  Still, with partners such as the Serum Institute of India and SK Bioscience now making commercial-grade product, approvals are being granted globally and the broad roll-out is on its way (Indonesia since last December; South Korea from February 14; EU and Australia from February 21 etc).

Curiously, while there is little controversy about the suitability as a covid vaccine, it has been under constant attack from media articles trying to tarnish the image of this company and vaccine.  Politico and Reuters in particular stand out by publishing harmful articles seemingly whenever the stock price is gathering momentum.

Today, I will exemplify just how bad this has become by dissecting the latest hit piece by Reuters paragraph by paragraph.

Rebuttal: On January 10 at the JP Morgan Healthcare conference, the CEO of Novavax Stan Erck told the audience that the EU had orderd 27 million doses for Q1 2022.  According to an Indian government site that tracks vaccine exports, Novavax' main manufacturing partner the Serum Institute of India (SII) has shipped 26 million doses into the EU during January.  These will have to be cleared following batch testing and checking the paperwork.   Unless the Indian government laboratories (CDL Kasauli) have passed and shipped bad product, it is unlikely the the SDS-PAGE and similar standard techniques will find something substantially different.

Regarding the Philippines situation, the vaccine is likely to be shipped in March once the 3-step process before roll-out has been satisfied:

1) approval (EUA on Nov 17, 2021)

2) HTAC recommendation for inclusion in national vaccination plan and DOH financing (29 December, 2021)

3) supply negotiations (ongoing)

Before that has occurred, Novavax and Serum will not send vaccine to places where it cannot be immediately used as they have only begun to turn stockpiled antigen and adjuvant into fully formulated products (~150M monthly capacity for SII sites alone).

The 10 million doses here likely refer to the 10 million doses that Novavax on January 10 confirmed have been shipped to Indonesia where they have been used already.  The doses are also shown on the Indian government export site.  Reuters, however, knows that it purposefully omitted that in fact 38 million doses have been shipped and that the balance (28 million doses) are currently undergoing batch release- some of which, as we will see later in the Reuters very own article, have actually been released for shipping.

That’s the normal process.  It’s great that Reuters acknowledges here that additional doses outside the 10 million in Indonesia are sitting in places like the EU ready to go out to healthcare providers once the paperwork is finished.  In Germany, many states are still planning with a February 21 start of vaccinations.  In Korea, SK Bioscience has today received batch clearance of the first batch of 840000 doses with vaccinations starting after Chinese New Year.

  

Standard cut-and-paste paragraph by Reuters, sadly adopted by the wider press, to ridicule the company. Which other company the size of Novavax 2 years ago has achieved what they did?  How about them filling in a major vaccine gap on the order of 2 billion doses, especially in countries that either cannot afford or do not have the cold chain required for mRNAs?

‘Tiny company’...well yes, if you consider Novavax 2 years ago on the brink of bankruptcy (biotech is a very high risk-high rewards business), but a company that will  soon hire their employee No 2000 is actually not so tiny in biotech terms.

But, of course, this is just part of Reuters ridiculing the company.

The only new information here as the broad roll-out is about to commence is that ‘individual vaccine batches’ have been cleared already in the EU.  Great to hear!  You are starting to contradict yourselves, Reuters.

Ominous mystery country will be revealed later in article. A bait for the reader to stay with article (spoiler alert: no, it's not the US or the EU).

 

80 million doses of the 1.1 billion doses promised to COVAX in Q1 as the company starts turning antigen + adjuvant into product and rich countries incentivizing the company to prioritize them.  Between Serum, SK Bioscience, Novavax' own sites that they had to set up and various other partners, a monthly run-rate of 200 million doses can be expected in the following quarters and should be able to satisfy the COVAX order.

 

 

Stan Erck said on January 10 that 10 million doses have been shipped in accordance with Indian government data.  An ‘Indonesian official who declined to be named’ apparently is only aware of the first November 26 shipment of 137500 doses, but not the subsequent December 98 million doses.  I guess fact-checking is optional for Reuters ‘journalists’.

But don't take it from Stan, but see it on the Indian government site or the United Nations OCHA January 5 Indonesia status update for yourself.

As I had noted before, Novavax and Serum will only send vaccine to countries that are ready to vaccinate.  The Philippines is not yet as it still needs to conclude its supply negotiations.

 

OK, if the Philippines regret having purchased other unused vaccine then by all means try and find reasons to renegotiate. We have all been there, done that.

 

Yes, I also had hoped that the vaccine would become available earlier than that after the December 20, 2021 approval, but the messaging in Germany has been February 21 for the first vaccinations and many states are making appointments accordingly.  Some are planning for February 28 and only a few early March.  ‘Early March’ would therefore indeed represent a delay.  We will see. Next up is South Korea next week.

 There is nothing factually wrong with this final paragraph, but it is symptomatic for Reuters to keep focusing on the hard work and challenges of bringing the first global protein-based covid vaccine to market.  Instead, it should have seized the opportunity- even if it was a critical article- to raise awareness of the unique opportunity for global health in front of us:

A better tolerated and efficacious covid vaccine without proven safety risks such as myocarditis and anaphylaxis.

As I look forward to getting my Novavax booster*, it is time to acknowledge the achievements of this tiny company where big ones such as Sanofi have failed.

*1st shot JNJ...rather severe chills, night sweats, headache, fever from 8-36 hours following vaccination; 2nd shot Biontech: better, but muscle ache around upper arm first, then entire body and general malaise 8-30 hours post vaccination. Now waiting for Novavax to reduce my chances of another 'bad day'.