Friday, April 16, 2021

Novavax’s COVID vaccine candidate fifth to reach final stage of testing in US

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A large U.S. study on another COVID-19 vaccine candidate was launched on Monday as states continue to deploy scarce supplies of the first vaccines to a country eagerly awaiting relief from the catastrophic outbreak.

Public health experts say there are more options in addition to the two vaccines currently being distributed – one made by Pfizer and its German partner BioNTech, the other from Moderna – are essential to amassing enough photos for the country and the world.

The candidate proposed by Novavax Inc. is the fifth to reach the final stages of testing in the United States. Some 30,000 volunteers are needed to prove whether the shot – a different type than its competitors Pfizer and Moderna – really works and is safe.

“If you want to have enough vaccines to immunize everyone in the United States that you want to immunize – up to 85% or more of the population – you’re going to need more than two companies,” Dr. Anthony Fauci, Principal US infectious disease expert told The Associated Press on Monday.

The coronavirus is responsible for an estimated 1.8 million deaths worldwide, including more than 330,000 in the United States. This month was the deadliest in the epidemic in the United States to date, with an estimated 65,000 deaths in December so far, according to the COVID Tracking Project. The country has repeatedly recorded more than 3,000 deaths per day in recent weeks.

And the United States could face a terrible winter: Despite warnings to stay home and avoid others over Christmas, nearly 1.3 million people passed through airports across the country on Sunday, the highest total. high in a day since the crisis in the United States nine months ago. .

The Trump administration’s Operation Warp Speed ​​expects to have shipped 20 million doses of Pfizer and Moderna vaccines to states by early January,less than initially expectedto the frustration of states and health officials trying to plan the shots.

There is no real-time tracking of how quickly people are receiving the first of two required doses. As of Monday, the Centers for Disease Control and Prevention had reported more than 2.1 million vaccinations out of 11.4 million doses shipped – but the agency knows that tally is exceeded. It may take days for reports from vaccine suppliers to arrive and be added to the site.

“Just because a vaccine comes in doesn’t mean we can set up an on-site clinic,” said Jenny Barta, a public health official from Carlton County, Minnesota.

But on Tuesday, his agency aims to vaccinate 100 people at a drive-thru clinic for emergency medical workers who Barta hopes could become a model for larger mass vaccination attempts. Nurses will carry the vaccine on cars lined up at a county-owned snow plow garage. Once the drivers have received their vaccines, they will wait in the parking spaces to make sure they do not have an allergic reaction before returning home.

“Vaccinating one person at a time is the way we are going to come out of this pandemic,” she said.

Yet another worry hanging over the vaccine rush: Will the shots block a new variant of the coronavirus that has emerged in Britain and could spread more easily? Fauci said data from Britain indicates vaccines will still protect against the virus, but researchers at the National Institutes of Health “will be examining it very intensively” to be sure.

A look at the pioneers of the global vaccine race:

GENETIC CODE VACCINES

The United States based its emergency deployment of the Pfizer-BioNTech vaccine and a similar vaccine made by Moderna and the NIH on studies suggesting they are both around 95% effective. Europe over the weekend began its first vaccinations with the Pfizer vaccine, and on January 6 will decide whether to add Moderna.

These shots are made with a brand new technology that injects a piece of genetic code for the advanced protein that covers the coronavirus. This messenger RNA, or mRNA, induces the body to produce a harmless spike protein, enough to trigger the immune system to respond if it later encounters the real virus.

Both vaccines should be stored frozen, with the Pfizer shot at ultra-low temperatures that make it difficult to deliver to poor or rural areas.

Other companies are working on developing their own mRNA candidates, including CureVac in Germany, which has launched a large study in Europe.

PROTEIN VACCINES

The Novavax candidate is manufactured differently, using what Fauci called “more proven” technology that only requires ordinary refrigeration. The Maryland-based company grows harmless copies of the coronavirus spike protein in the lab and mixes with an immune-boosting chemical.

Novavax has already enrolled 15,000 people in an advanced stage study in Great Britain and 4,000 in South Africa. The most recent and largest study, funded by the US government, will recruit volunteers at more than 115 sites in the United States and Mexico and will target high-risk seniors as well as volunteers from Black and Hispanic communities, who have been hit hard by the virus.

“We need to protect our community and our people,” said Reverend Peter Johnson, 75, a prominent Dallas civil rights activist who was among the first volunteers.

Two-thirds of participants will receive the vaccine and the rest dummy injections, a twist of previous vaccine studies that gave half of their volunteers a placebo. This should help researchers recruit people who are wondering whether it is better to participate in a study or take their turn for an existing photo, said Dr Gregory Glenn, chief research officer at Novavax.

For many people, that would be a long wait: Injections from Pfizer and Moderna go first to healthcare workers and nursing home residents, followed by people 75 and over and essential workers.

“If you wanted to hedge your bets, for most people who are not in these very high risk groups, the shortest route to getting the vaccine would be to sign up for a trial,” said the NIH director. , Dr Francis Collins.

TROJAN HORSE VACCINES

The next big vaccine news could come from Johnson & johnson, which targets a single dose COVID-19 vaccine.

Made in another way, it uses a harmless virus – a cold virus called adenovirus – to carry the spike gene around the body. By mid-December, J&J finished enrolling approximately 45,000 volunteers in a final phase study in the United States and half a dozen other countries. Fauci expects quick results next month.

In Britain, regulators are also considering phasing out a similar vaccine made by AstraZeneca and the University of Oxford.

Tests of the shots in Britain, South Africa and Brazil have suggested that they are safe and partially protective – around 70%. But questions remain about the vaccine’s effectiveness in people over 55 and how to interpret the results of a small number of people who received a different set of doses.

An American study of AstraZeneca shots is still recruiting volunteers; Fauci said researchers hope this will provide a clearer answer.

Companies in China and Russia are also producing adenovirus vaccines and have started administering them before final test results arrive. Argentina is expected to use the Russian vaccine soon.

VACCINES “KILLED”

Vaccines targeted at the tips are not the only option. Making vaccines by growing a pathogenic virus and then killing it is an even older approach that gives the body a glimpse of the germ itself rather than that single spike protein.

China has three of these “inactivated” COVID-19 vaccines in final testing in several countries and has allowed emergency use in some people ahead of the results. An Indian company is testing its own inactive candidate.

More health and Big Pharma coverage of Fortune:

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