Hackers have released a
whole new trove of reverse engineered data on Github.
And by
"hackers," I mean "scientists." And this treasure trove of
"reverse-engineered data" is the mRNA sequence.
That makes Moderna's
COVID-19 vaccine work.
Two Stanford scientists
were able to extract the entire mRNA sequence of Modern's COVID-19 vaccine and
code it on Github.
It is a website popular with software
developers looking to host and share source code.
1. Overview: posting Moderna mRNA sequence
Stanford scientists
recovered some residual droplets of the Moderna vaccine destined for the trash
can and.
After analyzing it,
published the mRNA sequence on Github, Motherboard boasts.
The document is four pages
long.
The first two are an
explanation from the team of scientists about the work.
"We did not reverse
engineer the vaccine.
We published the putative
sequence of two synthetic RNA molecules.
That have become
sufficiently prevalent in the general environment of medicine and human biology
in 2021," the scientists explained.
They had asked the Food
and Drug Agency (FDA) for permission to keep the empty vials.
That would be discarded at
the Stanford and Veteran's Affairs vaccination sites.
This is not the first time
a COVID-19 vaccine has been reverse engineered and shared online, Motherboard
notes.
On Dec. 25, 2020, PowerDNS
founder Bert Hubert previously used publicly available information about the
BioNTech/Pfizer vaccine to determine its mRNA sequence.
Still, "no one will
be making an mRNA vaccine in their garage anytime soon," engineer Jason
Neubert explained on his blog.
The manufacturing and supply chain behind this
type of drug is very complex.
2. Comment by Pauline Londeix
In October 2020,
The young pharmaceutical
firm Moderna promised that it would not attack any structure violating the
intellectual property.
That means the
intellectual property of its highly effective Covid-19 vaccine to produce its
own version, and this "for the duration of the pandemic.
As Pauline Londeix,
co-founder of the Observatoire de la transparence dans les politiques du
médicament, explained to us in February.
The promise is attractive
on paper but impractical in the real world.
"In the market as it
is, it can't work.
A generic company will not
take the risk if it does not have the legal guarantees - a press release is not
enough," she said.
There is another obvious barrier to this apparent goodness.
As a Moderna spokesperson
pointed out in an interview with the Washington Post, while the company has pledged
not to sue any copycats.
It has never promised to
make public the industrial and technological secrets of its vaccine.
And this is the less
entire true since they could be the first building block for many other
treatments to come.
3. Open source
That barrier may have just
been broken, however, thanks to a team of Stanford scientists.
As Motherboard reports,
they were able to get their hands on a few drops of the Moderna vaccine, known
as "mRNA-1273".
She then decoded its
secrets, using complex reverse engineering methods.
As well as systematic
comparisons with genetic material found in the bodies of previously vaccinated
people.
After contacting Moderna
about their research -a call that went unanswered-.
The team finally decided
to publish on GitHub the sequence of the messenger RNA (mRNA) encoding the
"Spike" protein of the SARS-CoV-2 coronavirus.
Which then allows the
body, after injection, to learn how to produce its defenses against future
viral aggression.
Like that of Pfizer and BioNTech's
"BNT162b2" vaccine, which others had already decoded, this sequence
is now accessible to anyone with an internet connection.
4. Stanford finding: great scientific value
In theory, it is therefore
possible for anyone with the necessary equipment and knowledge to reproduce the
Moderna vaccine at home.
Or at least in their
factory.
This is especially true
since the rest of the ingredients and methods needed to make the precious
mRNA-1273 are also well known.
Will we then see the birth
of an army of vaccine distillers, producing and bottling hectoliters of do it
yourself vaccine in their cellars and garages.?
This is, of course, highly
unlikely.
Setting up the supply and
production chain for such a product is a highly complex puzzle.
A difficulty no doubt
sufficient to protect Moderna from overly brave individuals who would like to
test its promise of no lawsuits.
Aware of this non-risk,
the U.S. Food and Drug Administration has given the publication the green
light, say the Stanford scientists.
On the other hand, a
generic company with strong backbone wanted to start producing Moderna's
vaccine without a formal license or supervised knowledge transfer.
This public disclosure of
its genetic secrets could be a very valuable time-saver.
The publication of the Stanford
research team and the details of the methods they used will be of great
scientific value in the future.
Moreover, the case shows
that science and medicine could probably advance even faster if they borrowed
some of the rules of open source.
5. Moderna's COVID-19 vaccine (mRNA-1273)
Who should be vaccinated first?
As with all COVID-19
vaccines, health workers at high risk of exposure and the elderly should be
vaccinated first.
As more vaccine becomes
available, other priority groups will need to be vaccinated.
Including those most affected by COVID-19 or
disadvantaged due to health inequities.
Who else can be
vaccinated?
The vaccine is safe and
effective in people with conditions associated with a higher risk of serious
disease.
Such as hypertension,
diabetes, asthma, lung, liver, or kidney disease, as well as all stable and
controlled chronic infections.
Although further studies
are needed in immuno-compromised individuals.
Individuals in this
category who are in a group for which vaccination is recommended can be
vaccinated after education and counseling.
People living with HIV are
at increased risk for severe COVID-19.
Candidates for vaccination who are known to be HIV-positive should be informed and counseled.
People who have already
had COVID-19 can be offered vaccination.
However, they may wish to
delay vaccination until six months after infection with SARS-CoV-2.
Vaccination may be offered
to a breastfeeding woman if she is in a group for which vaccination is recommended
(e.g., health care workers).
It is not currently
recommended that breastfeeding be interrupted after vaccination.
Should pregnant women be vaccinated?
Pregnancy puts women at
higher risk for severe COVID-19, but there is very little data to assess the
safety of the vaccine during pregnancy.
Nevertheless, based on
what is known about this type of vaccine.
There is no evidence to
suggest that it will pose any particular risks that outweigh the benefits of
vaccination for pregnant women.
For this reason, pregnant
women who are at high risk of exposure to SARS-CoV-2 (e.g., health care
workers).
Or who have co-morbidities
that increase the risk of severe disease may be vaccinated in consultation with
their health care provider.
Who should not be
vaccinated?
People with a history of
allergic reaction to any component of the vaccine should not be vaccinated with
this or any other mRNA vaccine.
Although vaccination is
recommended for the elderly because of the high risk of severe COVID-19 and
death the situation of very frail elderly persons.
With an expected life
expectancy of less than three months should be assessed on a case-by-case
basis.
The vaccine should not be
given to persons under 18 years of age until further studies are conducted.
What is the recommended
dosage?
SAGE recommends using
Moderna mRNA-1273 vaccine on a schedule of two doses (100 mcg, 0.5 ml each) 28
days apart.
If necessary, the interval
between doses can be extended to 42 days.
It is recommended to
follow the full schedule and use the same product for both doses.
Is the vaccine safe?
The vaccine has not yet
been approved by the WHO for emergency use under the EUL protocol.
But it has been reviewed
by the European Medicines Agency (EMA) and therefore meets the WHO criteria for
consideration under the SAGE.
The EMA has thoroughly
reviewed the quality, safety, and efficacy data for Moderna COVID-19 vaccine
and authorized its use throughout the European Union.
SAGE recommends that all
vaccinees be kept under observation for at least 15 minutes after vaccination.
Those who experience an
immediate severe allergic reaction to the first dose should not receive further
doses.
Long-term safety
evaluation involves ongoing follow-up of clinical trial participants as well as
specific studies…
And ongoing monitoring for
side effects or adverse events in vaccinees once vaccination is in place.
The Global Advisory
Committee on Vaccine Safety, a group of experts that provides independent and
authoritative advice to WHO…
On vaccine safety receives and evaluates
reports of potential safety issues, that may have international impact.
How effective is the vaccine?
The observed efficacy of
the Moderna vaccine is approximately 92% against COVID-19, and protection
begins 14 days after the first dose.
Is it effective against the new variants?
Based on the data available to date, new variants of SARS-CoV-2, including B.1.1.7 and 501Y.V2, do not alter the efficacy of Moderna's mRNA vaccine.
Data on new variants and
their influence on the efficacy of COVID-19 diagnostics, treatments, and
vaccines continue to be collected and analyzed on a regular basis.
Does it prevent infection and transmission?
It is not known whether the vaccine will prevent infection and transmission by the vaccinee.
Immunity lasts for several months, but the total duration is not yet known.
These
important issues are being studied.
In the meantime, effective public health measures should be maintained:
- mask wearing, physical distancing,
hand washing, respiratory and cough hygiene, avoidance of crowds and good
ventilation.
