are the most recent items we think are worth sharing with you. It took
us far longer than normal to do this newsletter because we wanted to
give a deep dive on the trial results that goes beyond the vague,
superficial news coverage.
3 reasons why Novavax hit a home run with positive results for its
Covid/Flu combination vaccine; Phase 2 trials to begin later this year.
the two main criteria we described as being key to the trial results,
Novavax hit it out of the park. On top of that, they also nailed it on a
criteria we didn't expect. Here's the scorecard:
SIDE EFFECTS: you'd think that combining Nanoflu (with 4 different flu
strains) and the Covid vaccine would result in at least somewhat higher
side effects than just Nanoflu alone or the Covid shot alone. And a
decent likelihood of much higher side effects and some likelihood of far
higher side effects. But Novavax managed to have the same levels of
side effects as either of the vaccines on their own.
has the second best immunogenicity after Nanoflu, which is stronger
than Fluzone by between 30% and 70% depending on which flu strain is
studied. What would you prefer: a) get an RNA Covid shot one week with
high side effects. Then return a week later and get a Fluzone shot with
some amount of side effects? or b) get protection against both with one
shot with far less side effects than RNA?
Score: A+ 2)
IMMUNE RESPONSES. For fighting both Covid and flu, the immune responses
generated were on par with the vaccines on their own. If the immune
responses were somewhat lower, the program likely could have continued
because Nanoflu is already far ahead of the second best vaccine, and
Novavax's Covid vaccine is somewhat stronger than Pfizer and much
stronger than J & J and AstraZeneca. But there was a risk that the
immune responses from the combo shot could have been much lower or even
far lower, both of which would have probably ended the program.
However, the immune results were not far lower, much lower or even somewhat lower. They were the same.
Score: A+ 3)
MAJOR REDUCTIONS IN ANTIGEN: The results showed it could use as much as
50% less antigen than it did in both doses separately. It also would
use 50µg of Matrix M adjuvant total, instead of a total of 125µg
if there were two separate shots (50 for the Covid vaccine and 75 for
Nanoflu). This means: a) the vaccine can reach more people. b) far
higher profit margins. and c) enough extra space available to add an RSV
antigen and probably 2 to 3 Covid strains for a total of 3 to 4 Covid
strains. On the last point, even
if no reduction in antigen had been achieved, many experts thought
Novavax would probably be able to also fit an RSV antigen into the combo
vaccine. That would make it protect against the 3 biggest respiratory
illnesses in the world. The Covid vaccine has 5µg of antigen, and Nanoflu has 240 µg of antigen (60µg for each strain). If the combo vaccine uses only 120µg of flu antigen, that should free up 120µg
of space for 2 or 3 more Covid strains plus the RSV antigen. It should
be able to easily do the RSV antigen plus a second Covid strain. The
RNA vaccines can't get anywhere close to that. They mostly likely can't
even get 4 flu stains in one shot. Trying to add even one Covid strain
would be pretty much impossible. By contrast, Novavax should be able to
easily do 4 flu strains, 2 to 3 Covid stains and RSV in one shot.
Score: A+ Additional
bonus: Novavax said that multiple sets of dose sizes and adjuvant sizes
were successful. If only 1 had been successful, that's not as promising
and there's less wiggle room. Multiple successful options is great.
become very clear that Covid vaccines are not going to last more than
about 4 to 7 months, kind of similar to flu vaccines. Moderna's bivalent
Covid vaccine (with antigen for both Omicron and the original strain)
only makes enough antibodies to add about 1 month to its durability.
That means people need to get boosted between August and December, and
by the following fall, immunity will have dramatically waned. Most
governments, healthcare systems and insurance companies will put major
efforts into fall vaccination drives in order to greatly reduce
healthcare costs, save lives, prevent hospitals from being overwhelmed
and reduce economic losses.
people are misinterpreting that governments and health experts aren't
doing very much to get people to receive additional shots now.
Governments and experts know that: 1) most people around the world
completed their primary series between April and November of 2021, and
half of people don't want to get a shot more than once a year. So a lot
of people are not even at the 12 month mark. 2) they also know that many
people at the moment have Covid fatigue and the timing isn't ideal to
push another shot so soon. and 3) If most people will only get 1 shot
per year, it's best for it to be between September and November so
immunity is high during the Covid season. The last 2 years every country
in the world was hammered between December and January.
governments, most experts, most doctors and most insurers know what's
at stake this coming fall and winter. They will do a promotional blitz
for Covid shots, and the media will be on board. Many media outlets and
health experts will point out that there's a high efficacy alternative
for people who are hesitant about RNA. PRESS RELEASE: Here is an excerpt from Novavax's press release:
The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic. ...
safety and tolerability profile of the combination vaccine was
consistent with the stand-alone NVX-CoV2373 and quadrivalent
nanoparticle influenza vaccine reference formulations in the trial. The
combination vaccine was found to be generally well tolerated. Serious
adverse were rare and none were assessed as being related to the
ARTICLE: Here are excerpts from an article about the combination vaccine:
Novavax Inc.’s experimental combination vaccine for Covid-19 and the seasonal flu just got some good news. ....
But these results thus far allow the company to start a phase 2 trial by the end of the year, said Dr. Filip Dubovsky,
chief medical officer for Novavax (NASDAQ: NVAX). In doing so, he said,
the company will also evaluate the best dosage for a planned final
phase of testing, among a larger group of patients, to determine if it
indeed protects against both Covid and the flu.
latest trial also found similar outcomes for the combination
candidate’s safety and tolerability, when compared with the stand-alone
vaccines. Serious side effects were rare and unrelated to the vaccine,
the company said. .... Novavax had started enrolling patients in this study in September, about six months after first considering the concept.
The company aims to eventually earn FDA approval for the combination vaccine, which Novavax President and CEO Stanley Erck has called “a key component” of its pipeline. ....
OF PHASE 2 START: Though Novavax said the trial would start "by" the
end of the year, many investors in online discussion forums thought it
meant "at" the end of the year, and expressed disappointment it wasn't
sooner. However, we recommend considering the following points: *
When Novavax did one of the Nanoflu trials, one of the flu strains
changed at the last minute, and it took about 1 1/2 months longer than
planned for them to obtain the supplies needed for that trial. They were
hammered by news outlets and many investors, even though the change in
strain was not their fault. In the last year, they've also been
viciously attacked every time an estimated frame didn't pan out. So it's
likely they've decided to be conservative with any timelines.
Last year, Novavax said on a Friday that they'd release some results
sometime in the next week and released them on Monday, about 1 business
day into the 5 business days. Also, on one of their Nanoflu trials, they
said they expected results by the end of Q1, and they released them on
January 3rd. So while more than half of the time the action occurs near
the end of the period, and much of the time it occurs after the end of
the period, some of the time it's very, very early in the time range.
They progressed the Nanoflu trials very rapidly, completing 3 of them
in only 3 years. For the Covid vaccine, they started their phase 1,
phase 2, and UK phase 3 trials very rapidly. They also first stated an
intention to do a combination vaccine in March, 2021 and 5 1/2 months
later they started the first trial. 5 1/2 months from the date of these
results is early October. Also, the majority of the design of phase 2 is
already done. So it could possibly start in August or September.
they start the phase 2 in September or December, they're far ahead of
everyone else and they are the only company with a clear path to
success, given the RNA vaccines won't be able to pull off a combo shot,
and viral vectors can't do it. Sanofi is the only other company with a
shot, and they have been blowing off doing a combination vaccine. Plus,
they don't even have an approved Covid vaccine yet. Also, their flu shot
is weaker, and their Covid vaccine would probably also be weaker, if it
even gets authorized at all. In a future newsletter, we'll examine the size of the combination vaccine market.
2) After meeting with the Novavax CFO, Jefferies analysts increase their estimated Q1 earnings to $3.67 per share, 2022 earnings to $37.92 per share and price target to $198
Here is a relevant clip with the latest price target and Q1 estimate for Novavax:
analysts at Jefferies Financial Group raised their Q1 2022 EPS
estimates for shares of Novavax in a report released on Tuesday, April
19th. Jefferies Financial Group analyst Roger Song now anticipates that
the biopharmaceutical company will earn $3.67 per share for the quarter,
up from their prior forecast of $3.55. Jefferies Financial Group has a
“Buy” rating and a $198.00 price target on the stock. .... According to MarketBeat.com, the stock currently has an average rating of “Buy” and an average price target of $204.86.
meeting with the Novavax CFO, Jefferies also gave the following
quarterly forecasts for this year, and annual forecasts for the next
analysts at Jefferies Financial Group boosted their Q2 2022 earnings
per share estimates for Novavax in a note issued to investors on
Tuesday, April 19th. Jefferies Financial Group analyst R. Song now
expects that the biopharmaceutical company will earn $6.94 per share for
the quarter, up from their previous estimate of $4.34. Jefferies
Financial Group has a “Buy” rating and a $198.00 price objective on the
stock. Jefferies Financial Group also issued estimates for Novavax’s Q3
2022 earnings at $10.86 EPS, Q4 2022 earnings at $16.14 EPS, FY2022
earnings at $37.92 EPS, FY2023 earnings at $13.95 EPS, FY2024 earnings
at $9.57 EPS, FY2025 earnings at $11.36 EPS and FY2026 earnings at
average EPS from 2022 to 2026 is $17.18 per share. At a PE ratio of 10,
the valuation is $171.8 per share. At a PE of 15, it's $257.7. Note
that the Jefferies price target of $198 and the MarketBeat consensus
target of $204.86 are both between those two. Here is the link:
clarifies no data is missing from the Novavax EUA filing. Novavax says
it expects FDA expert panel to be scheduled "very soon."
In a CNBC story at around the same time as the combination trial
results, an FDA official said the review of the Novavax vaccine
was complex, and implied that needed data was missing. This blunted the
positive news from the trial results, as the share price actually went
down instead of up. Later the FDA made a statement to Yahoo Finance
clarifying that no data was missing. Also in the Yahoo Finance article,
both the FDA and Novavax conveyed that nothing was wrong, and that they
are only engaged in the normal back and forth of questions during
a review period. However, the
CNBC story got about 10 times as much coverage, partly because CNBC's
audience is far bigger than Yahoo's, and partly because other news
outlets picked up the CNBC story. The CNBC story scared many investors.
It should be noted that every other major drug agency in the world was
able to pretty easily handle the Novavax filing, and many far
smaller drug agencies were able to handle the filing and review it
quickly. This includes Australia, whose population of 25
million people is only 8% the size of the US; the UAE, which is 3% of
the size of the US; and Switzerland, which is 2.5% of the size of the
US. So the attempt by the FDA official to make an excuse for the FDA's
tardiness was quite inaccurate. Here is a clip from an article that includes the quote from the FDA official:
a meeting convened by the Centers for Disease Control and Prevention
(CDC), Dr. Doran Fink, a deputy director of FDA’s Center for Biologics
Evaluation and Research (CBER), acknowledged that some are anxiously
waiting for the entry of an alternative to current vaccine options.
(NVAX) COVID-19 shot, identified as NVX-CoV2373, is a protein-based
vaccine authorized in multiple countries and regions, including Europe.
However, the Maryland-based biotech has yet to receive the FDA nod for
the vaccine even months after the regulatory submission.
is an incredibly complex review process that involves review of not
just clinical data but also manufacturing data that will be needed to
make a determination about emergency use authorization,” Dr. Fink said,
according to CNBC’s Meg Terrel.
once we have all the data we need to complete our review, again, we
will work diligently to present those data to our advisory committee and
in a timely manner in order to make a decision,” Dr. Fink added.
• Here are excerpts from the Yahoo Finance article:
Gregory Glenn, president of research and development, told attendees at
the World Vaccine Congress the company was optimistic about its
COVID-19 emergency use authorization (EUA).
a statement later in the day, the company said, "We continue to have a
productive dialogue with the FDA as they review data and we answer
inquiries related to clinical and manufacturing data as expected. We
look forward to scheduling our VRBPAC [Vaccines and Related Biological
Products Advisory Committee] meeting in the near future as indicated by
an advisory committee for the U.S. Centers for Disease Control and
Prevention (CDC) Wednesday, a U.S. Food and Drug Administration official
indicated that the FDA was still awaiting manufacturing data from
But an FDA spokesperson later said it was nothing more than the usual back-and-forth as part of the regulatory process.
the FDA cannot predict how long its evaluation of the data and
information will take, the agency will review the EUA request as
expeditiously as possible using its thorough and science-based approach.
The agency plans to schedule a meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC) to discuss the EUA
request with the FDA’s panel of outside scientific and medical experts,"
according to the spokesperson. ....
Neither side indicated that there was any delay in the process.
A local business journal also reported the following:
company said it couldn't offer a specific timeline for the FDA's
decision on its Covid vaccine under review for emergency use. It also
plans to seek full approval for that vaccine in the U.S. in the second
half of 2022, Erck said on a company earnings call earlier this year.
interact with [the FDA] frequently. It’s a friendly interaction and
they’re just reviewing the file,” Dubovsky said Wednesday.
4) Novavax announces new vaccine booster study in adolescents in Phase 3 Prevent trial
Here is an excerpt from Novavax's press release on the announcement of a new vaccine booster study:
study will evaluate the safety and immunogenicity of a third dose of
NVX-CoV2373 among trial participants aged 12 through 17.
see the ongoing need for alternative vaccine options because we are
continuing to monitor spikes in COVID-19," said Gregory M. Glenn, M.D.,
President, Research and Development, Novavax. "The expansion of our
PREVENT-19 booster trial into the pediatric population reinforces our
commitment to seek to make our vaccine available to a broader
PREVENT-19 trial participants aged 12 through 17 are now eligible to
receive a third booster dose of NVX-CoV2373. The booster dose is
identical to the active vaccine previously administered to the
participants in a two-dose regimen (5 micrograms of recombinant spike
protein plus 50 micrograms of Matrix-M™ adjuvant) and may be
administered at least five months after receipt of active vaccine.
Post-booster objectives include the assessment of the humoral immune
response 28 days after the administration of the booster dose, as well
as describing COVID-19 disease. Initial results are expected during the
second half of 2022.
5) US Justice appeals ending of mask mandate on public transportation and airplanes
The US Justice Department has appealed the ending of a mask mandate on public transportation and
airplanes as there is no end to Covid in sight. Despite wishful
thinking from much of the public, the pandemic is not over and the virus
continues to mutate. There have been at least 10 new mutations, one of
which has already spread rapidly. Here is an excerpt from an article:
U.S. Justice Department on Wednesday appealed a judge's ruling ending a
mask mandate on public transportation and airplanes, a spokesman said,
after the Centers for Disease Control and Prevention (CDC) said the
measure was still needed.
U.S. district judge ruled on Monday that the mandates, which apply to
planes, trains and other public transportation, were unlawful. The
Justice Department said it would appeal the ruling if the CDC determined
the 14-month-old mandate was still needed.
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