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Coronavirus USA

Coronavirus USA: what phase is the Pfizer and Moderna vaccine in?

The two pharma giants launched two 30,000-subject trials of Covid-19 vaccines, the first late-stage studies supported by the Trump administration.

Donald Trump delivers a speech during a tour of the Fujifilm Diosynth Biotechnologies' Innovation Center, where components for a potential coronavirus disease vaccine candidate are being developed.

The development of a vaccine against the novel coronavirus is widely viewed as the only guaranteed end to the global Covid-19 pandemic, leading to several international non-profit partnerships and a race among private pharmaceutical companies to roll out a safe and effective drug against the disease. The questions that remain are when a vaccine will be available and to what extent it will be obtainable worldwide.

Dr. Anthony Fauci, the top U.S. infectious diseases official, said in May that it is “conceivable” a vaccine could be available as early as December but warned that any timeline “is never a promise” and suggested 2021 would be the key year. That is in line with most projections leaning towards early 2021 as a probable starting point for mass vaccination programs. On Monday, Pfizer Inc and Moderna Inc announced they are ready to start Phase III trials of Covid-19 vaccines.

Human trials to begin in U.S.

The two pharma giants launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, the companies have announced.

The trials are the first late-stage studies supported by the Trump administration's effort to speed development of measures against the novel coronavirus, adding to hope that an effective vaccine will help end the pandemic.

Both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods but does not have an extensive track record.

So-called mRNA, or synthetic messenger RNA (mRNA), teaches the immune system to recognize and neutralize the coronavirus by mimicking its surface.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.

Pfizer has an agreement to sell vaccines for 50 million people to the U.S. government for around $2 billion, if the vaccine is effective.

More than 150 coronavirus vaccine candidates are in various stages of development worldwide, with some two dozen prospects already conducting human testing.

Vaccine in 2020 "a stretch goal"

Johnson and Johnson is launching clinical trials in the U.S. this week and could start a larger, late-stage trial as early as September. British drugmaker AstraZeneca Plc said it will begin large-scale U.S. trials this summer of its vaccine under development with Oxford University researchers.

"Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it's the right goal for the American people," National Institutes of Health (NIH) Director Francis Collins said in a release announcing the start of Moderna's large Phase III trial.

Manufacturers are ramping up production while testing is underway in order to respond as soon as possible to virus, which is still spreading rapidly around the world. Covid-19 has killed nearly 650,000 people worldwide and battered economies.

Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters on a call.

Pfizer said that if the trial was successful, it could seek regulatory approval as soon as October and supply vaccines for 50 million patients, at two doses each, by the end of the year.

Pfizer aims for about 1.3 billion doses by the end of 2021, and Moderna aims for 500 million-1 billion doses a year, beginning 2021, Moderna Chief Executive Stephane Bancel said on the call.

The late-stage trials are designed to evaluate the safety of vaccines and determine if they can prevent symptomatic Covid-19.

Fauci said a readout from the Moderna trial could come by November or even earlier. Fauci said he was "not particularly concerned" about the vaccine's safety after seeing data from earlier, smaller trials. He also said he had briefed President Donald Trump about the trial the Oval Office on Monday.

As other companies ready inoculations, the Covid-19 Prevention Network, a U.S. government-funded program formed by the NIH, said it plans to roll out a large-scale clinical trial of a Covid-19 vaccine candidate with at least 30,000 participants each month through fall.

Global Covid-19 vaccine development

The Coalition for Epidemic Preparedness Innovations (CEPI) is aiming to raise a $2 billion worldwide fund for investment in and development of vaccine candidates. The coalition said in April that a vaccine could be available under emergency use protocols by early 2021.

Meanwhile, the WHO reported earlier in July that 75 countries have expressed an interest in joining the COVAX Facility, a global initiative to develop a vaccine also involving 90 developing nations. Among this group are more than half of the G20 countries and every 60 percent of the world’s population is represented.

Through COVAX our aspiration is to be able to vaccinate the most vulnerable 20% of the population of every country that participates, regardless of income level, by the end of 2021. Ensuring fair access is not only a matter of equity; it is the fastest way to end this pandemic,” said Dr. Richard Hatchett, CEO of CEPI.


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