taken on August 13, 2020, Biotechnology company Moderna protocol
files for Covid-19 vaccinations are kept at the Research Centers of
America in Hollywood, Florida. – Moderna, one of two companies
currently holding phase 3 trials in the US for a Covid-19 vaccine,
took the unusual step on September 17, 2020, of publishing its
trial protocols after calls for more transparency. (Photo by
CHANDAN KHANNA / AFP)
US biotech firm Moderna, one of nine companies in
the late stages of clinical trials for a Covid-19 vaccine, has
become the first to publish the complete blueprints of its study
following calls for greater transparency.
The initiative puts pressure on other companies to follow suit,
especially Pfizer, the other American company currently carrying
out Phase 3 trials in the US.
This is the final stage before approval, in which a vaccine and
a placebo are tested on thousands of participants to verify the
medicine is safe and effective.
The vaccine race has become deeply politicized in the US in the
run-up to the presidential election in November, as President
Donald Trump touts one against criticism of his handling of the
pandemic.
Trump repeated on Wednesday that the first vaccine would be
approved by October, increasing concerns that the White House will
place pressure on the approval body, the Food and Drug
Administration (FDA).
“I don’t trust Donald Trump,” his rival from the Democratic
party Joe Biden said Wednesday.
Experts and officials in the Republican president’s
administration agree that it’s not possible to predict the results
of the trials that are underway, and it’s highly unlikely to have
strong data before the end of 2020.
Vaccine doses will be initially very limited, according to
health authorities.
Moderna’s CEO Stephane Bancel said on Thursday his company would
know whether their vaccine works by November.
October is possible but unlikely, he told CNBC.
The trial protocol published Thursday, which runs to 135 pages
and is marked “confidential,” fixes the parameters of the
experiment.
The most important of these is how it will judge whether results
are conclusive. – Wait for it –
The reality of an immunization trial is that it’s necessary to
wait until a certain number of volunteers become naturally
infected, in order to compare outcomes in the placebo group against
the group given the vaccine.
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So the decline in the rate of infection in the US could
theoretically delay the results — possibly until December, said
Bancel.
As of Thursday, Moderna had recruited 25,296 volunteers. Among
them, 10,025 had received their second dose, 28 days after the
first.
It’ll take a few more weeks to recruit the full quotient of
30,000 participants and for them to receive their second doses.
Only Covid-19 infections recorded two weeks or more after the
second dose are counted, to give the vaccine sufficient time to
take effect.
Interim analyses by a committee of independent experts are
planned over the course of the trial to verify whether a high
statistical threshold of effectiveness has been reached, and to
monitor for serious side effects.
The FDA has stated its bar for approval is a vaccine that
reduces the risk of falling sick with Covid-19 by 50 percent.
“This has the key information (for) stopping rules, interim
analyses and efficacy assumptions. Applaud their transparency,”
Eric Topol, director of the Scripps Research Institute and one of
the critics leading the charge against possible political
interference, told AFP.
– Pressure on –
Moderna also said that 28 percent of its participants were from
racial minority groups.
Having sufficient participants among black and Hispanic people
in particular is crucial in obtaining statistically representative
results for these communities that have been disproportionately hit
by the pandemic.
The decision by Moderna, which has received $2.5 billion in US
government money, now leaves the spotlight on Pfizer, the other
company in the running for the first US authorization.
Its CEO has repeatedly said the company will have its results by
the end of October, which is in line with Trump’s wishes.
The other frontrunner is AstraZeneca, which has co-developed a
vaccine with the University of Oxford.
The medicine’s global trials were suspended last week after a
participant had an unexplained illness, but were later restarted in
the UK, Brazil, and South Africa. The US remains the exception for
reasons that aren’t yet known.
“Transparency is crucial to overcome vaccine hesitancy. Other
vaccine makers should follow @moderna_tx lead,” tweeted Angela
Rasmussen, a virologist at Columbia University.
AFP
Anti-Corruption: FG launches Database
for Stolen Assets Tracing
The Federal Government
has officially launched a Central asset database initiative
designed to trace, track and recover stolen assets.
The Honorable Attorney
General of the Federation and Minister of Justice (HAGF), Abubakar
Malami SAN made this known at the programme tagged:
‘Formal launch of the Central Database under Asset Tracing,
recovery and management Regulations 2019 and the Central Criminal
Justice Information System (CCJIS) under the National
Anti-Corruption Strategy 2017-2019, and Sensitization Workshop for
stakeholders in Abuja, on 17th September,
2020 .
Delivering his speech
at the occasion, Abubakar Malami SAN described the initiative as
continual efforts and further commitment of the President Muhammadu
Buhari’s administration to fighting corruption in the country.
He said the initiative
was also targeted at deepening transparency in the asset recovery
effort in accordance with the United Nations Charter.
Malami explained,
“Apart from our involvement in the Open Government Partnership
initiative, anti-corruption agencies saddled with responsibilities
have been given adequate support to succeed.
He disclosed that the
Federal Government of Nigeria has declared its commitment in
deploying technology to every nook and crannies of the
Federation to enable the relevant stakeholder key into the 21st
Century technology in Nigeria through Central Database.
The Minister pointed
that this will enable the relevant stakeholder key
into the 21st Century technology in Nigeria which
guarantees transparency and ensures there is accountability on the
part of public officers.
He expressed the
Ministry’s readiness to work with the Judiciary at all
levels, Anti-Corruption Institution at both the States and Federal
levels and the Nigerian Police in order to run the information
center real time.
“Let me state in
addition to what the Solicitor General of the Federation and
Permanent Secretary has said about the Central Criminal Justice
Information System (CCJIS), the Office of the Attorney General of
the Federation and Minister of Justice, is developing legislation
for the full implementation and operation of the CCJIS in order to
ensure compliance” he explained
In his opening
remarks, the Solicitor General of the Federation and Permanent
Secretary, Federal Ministry of Justice, Dayo Apata,
SAN, disclosed that, the Central Database for
assets recovery and Central Criminal Justice Information System are
practical expression of the administration’s willingness to have a
one-stop information centre where timely and verifiable information
is sourced and provided to all Stakeholders, whether as private,
public, local or international entity.
He said, “let me
recall that, following the issuance of the asset tracing, recovery
and management regulations on the 29th October,
2019 by the AGF, the need to put in place a centralized database
for the storage of records of all recovered assets within and
outside of Nigeria as contained in Section 3 of the ATRM
Regulations, 2019 became obligatory for Nigeria. Hence, the AGF
team worked tirelessly with minimal funding to develop these
tools.”
Enumerating the
objectives of the ATRM, Apata said, it is centralised asset
depository for easy coordination for all Stakeholders with regards
to asset Management. Most importantly, the Central Database for
recovered assets compliments Central Criminal Justice Information
System.
Speaking on National
Anti-Corruption Strategy (NACS), the Solicitor General of the
Federation explained that, following the directives by the Federal
Executive Council (FEC) on 5th July, 2017, the
Ministry under the HAGF developed a robust implementation plan for
NACS.
“Let me inform
Stakeholders present here today that, Federal Ministry of Justice
has developed Central Criminal Justice Information System under the
NACS in line with ‘Pillar 1’ on prevention, with specific emphasis
on strengthening the legal, institutional and operational framework
designed to prevent and combat corruption”.
He therefore
encouraged all relevant Stakeholders and Nigerians to never relent
in fight against corruption for the battle requires
perseverance.
In his good will
message, the Speaker, House of Representatives, RT. Hon Femi
Gbajabiamila represented by the Chairman, House Committee on
Justice, Hon. Ugonna Ozurigbo said that the ATRM is a panacea to
rekindling the value system of a nation. He added that it is a core
value of good governance and effective management of this venture
will serve as a deterrent to would-be fraudulent minded individuals
who may find themselves in public offices.
He described the
initiative as apt for the 21st century, assuring
that NASS will continue to empower relevant agencies to recover
looted assets via quality legislation.
In a short remark, the
both acting Chairman of the Economic and Financial Crimes
Commission (EFCC) and Chairman, Independent Corrupt Practices and
Other Related Offences Commission (ICPC), DCP Mohammad Umar and
Professor Bolaji Owasanoye jointly described the initiative as a
welcome development, saying they were ready to key into the
initiative.
According to Umar, the
initiative will enhance effective management of seized assets,
saying the agency is already maintaining a database which contains
all frozen or seized assets.
While commending the
federal government, Owasanoye described the initiative as long
overdue, saying apart from preventing any form of looting and
re-looting of assets, the initiative will remain a key component of
transparency and accountability.
The British High
Commission through its representative, Andrew Clowes also pledged
its partnership with the Nigeria government in the fight against
corruption, describing it as a step forward.
Also, in his goodwill
message, the Auditor-General for the Federation, Mr Anthony Ayine
represented by Andrew Magaji lauded the Ministry on the initiative
of ATRM.
He commended the HAGF
for the memo presented to the Federal Executive Council on a bill
to seek the approval of the Council to transmit to the National
Assembly for passage into law “the proceeds of Crime and Management
Agency Bill” which to him was a move in a right direction.
Also present at the
event are; Representative of Inspector General of Police, FIRS
Chairman, Muhammed Nani, Representative of UNODC and Civil Society
Organisations and other relevant stakeholders.
Modupe
Ogundoro
Deputy Director
17th September, 2020