Moderna shares COVID-19 vaccine trial blueprints, Pfizer follows
This combination of file pictures created on August 05, 2020 shows a sign for Pfizer pharmaceutical company on a building in Cambridge, Massachusetts, on March 18, 2017 and the Moderna headquarters in Cambridge, Massachusetts on May 18, 2020. The CEOs of nine companies developing vaccines against Covid-19 on September 8, 2020 pledged to "uphold the integrity of the scientific process" amid concern Donald Trump will pressure regulators to approve a vaccine ahead of the presidential election in November. "We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles," said the CEOs.The statement was signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.
AFP/DOMINICK REUTER, Joseph Prezioso
Moderna shares COVID-19 vaccine trial blueprints, Pfizer follows
Ivan Couronne (Agence France-Presse) - September 18, 2020 - 7:58am

WASHINGTON, United States — US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, became the first to publish the complete blueprints of its study following calls for greater transparency. 

Pfizer, the other American company currently carrying out Phase 3 trials in the US, followed suit a short time later and there is now added pressure for the remainder to do the same.

Phase 3 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 a quick vaccine in response to 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.

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.

The Moderna trial protocol "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, left a spotlight on Pfizer, whose CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump's wishes.

A spokeswoman told AFP Pfizer has traditionally not shared the full in-depth study protocol, but "the Covid-19 pandemic is a unique circumstance and the need for transparency is clear." 

"As a result, the company is making the full protocol for its self-funded Covid-19 vaccine pivotal study available to reinforce Pfizer's longstanding commitment to scientific and regulatory rigor that benefits patients."   

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.

COVID-19 VACCINE MODERNA NOVEL CORONAVIRUS PFIZER
As It Happens
LATEST UPDATE: October 27, 2020 - 9:45am

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

October 27, 2020 - 9:45am

Brazil is a top testing ground for vaccines against COVID-19, but its plans for vaccinating its own population have been plunged into chaos by a political war waged by President Jair Bolsonaro.

Hit hard by the new coronavirus, Brazil has been tapped to help test several of the leading vaccine candidates, giving it a potential edge in the race to secure access to an eventual shot.

That could be a welcome silver lining for the country of 212 million people, which has the second-highest COVID-19 death toll in the world, at more than 157,000.

But one promising test vaccine, developed by Chinese pharmaceutical firm Sinovac Biotech, has triggered the ire of the far-right president, who last week canceled his health minister's plan to buy 46 million doses. 

The vaccine's most visible proponent in Brazil is the governor of the large and wealthy state of Sao Paulo, Joao Doria, who also happens to be one of Bolsonaro's top opponents. — AFP

October 21, 2020 - 12:38pm

Brazil's health minister says the country would add the Chinese-made CoronaVac vaccine against COVID-19 to its national immunization program, despite a political and diplomatic row over whether to use it.

Health Minister Eduardo Pazuello says the federal government had reached a deal with Sao Paulo state, which is helping test and produce the vaccine, to buy 46 million doses to be administered starting in January.

"This vaccine will be Brazil's vaccine," in addition to another developed by Oxford University and pharmaceutical firm AstraZeneca, Pazuello says in a video meeting of the South American country's 27 governors. — AFP

October 7, 2020 - 3:41pm

The US Food and Drug Administration made public its guidance for issuing emergency approval for a COVID-19 vaccine on Tuesday, making it clear it wants to see follow-up two months after trial volunteers have their second dose.

It is therefore unlikely for President Donald Trump's administration to have a vaccine on the market before the November 3 election, something the president frequently says is on the cards.

"Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile," the document said. — AFP

October 7, 2020 - 7:33am

The US Food and Drug Administration made public its guidance for issuing emergency approval for a COVID-19 vaccine on Tuesday, making it clear it wants to see follow-up two months after trial volunteers have their second dose.

It is therefore unlikely for US President Donald Trump's administration to have a vaccine on the market before the November 3 election, something the president frequently says is on the cards.

"Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile," the document said.

The two companies that are furthest along in their vaccine trials, Moderna and Pfizer, both began their final stages at the end of July, and both require two separate injections 28 days apart. — AFP

September 30, 2020 - 8:10am

The World Bank says it has asked its board of directors to approve $12 billion to help poor countries purchase and distribute eventual vaccines against COVID-19.

The bank has already implemented emergency response programs in 111 countries and the extra money, if approved, would be aimed at low- and middle-income countries.

"An effective and safe COVID-19 vaccine is the most promising path forward for the world to reopen safely," a World Bank spokesman says. — AFP

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