A major US study of another COVID-19 vaccine candidate began on Monday, as states continue to distribute scarce supplies of the first vaccines to a nation that eagerly awaits relief from the catastrophic outbreak.
Public health experts say that more options, in addition to the two vaccines being distributed – one made by Pfizer and its German partner BioNTech, the other by Moderna – are essential to obtain sufficient injections for the country and the world.
The Novavax Inc. candidate is the fifth to reach the final testing phase in the United States. About 30,000 volunteers are needed to prove whether the injection – a different type from Pfizer and Moderna’s competitors – really works and is safe.
“If you want to have enough vaccine to vaccinate all the people in the U.S. that you would like to vaccinate – up to 85% or more of the population – you will need more than two companies,” Dr. Anthony Fauci, said the leading infectious disease specialist in the United States United to The Associated Press on Monday.
The coronavirus is responsible for about 1.8 million deaths worldwide, including more than 330,000 in the United States. This was the most lethal month of the outbreak in the United States so far, with about 65,000 deaths in December so far, according to the COVID Tracking Project. The country has repeatedly recorded more than 3,000 deaths a day in recent weeks.
And the United States may be facing a terrible winter: despite warnings to stay home and avoid other people at Christmas time, almost 1.3 million people passed through the country’s airports on Sunday, the highest total of a day since the crisis hit the US nine months ago.
The Trump administration’s Warp Speed operation hopes to have sent 20 million doses of the Pfizer and Moderna vaccines to states in early January, less than originally estimated to the frustration of the states and health officials trying to schedule the injections.
There is no real-time tracking of how quickly people are receiving the first of the two required doses. As of Monday, the Centers for Disease Control and Prevention had reports of more than 2.1 million vaccinations from 11.4 million doses sent – but the agency knows the count is out of date. It may take days for reports from vaccine providers to arrive and be added to the site.
“Just because a vaccine arrives, it doesn’t mean we can get a clinic on site and working,” said Jenny Barta, a public health official in Carlton County, Minnesota.
But on Tuesday, his agency plans to vaccinate 100 people at a drive-thru clinic for emergency medical workers that Barta hopes will become a model for major mass vaccination attempts. Nurses will carry vaccines for cars lined up in a county-owned snowplow garage. After drivers get the vaccinations, they will wait in the parking spaces to make sure they don’t have an allergic reaction before going home.
“Vaccinating one individual at a time is how we are going to work to get out of this pandemic,” she said.
One more concern hanging over the vaccine confusion: will the vaccines block a new variant of the coronavirus that has emerged in Britain and can spread more easily? Fauci said that data from Britain indicate that vaccines will still protect against the virus, but that researchers at the National Institutes of Health will be “looking at it very intently” to be sure.
A look at the pioneers in the global vaccine race:
GENETIC CODE VACCINES
The US based the emergency launch of the Pfizer-BioNTech vaccine and a similar one made by Moderna and NIH on studies that suggest that both are approximately 95% effective. Over the weekend, Europe started its first vaccinations with the injection of Pfizer and, on January 6, will decide whether to add that of Moderna.
These injections are made with an entirely new technology that injects a piece of genetic code into the spike protein that lines the coronavirus. This messenger RNA, or mRNA, induces the body to produce some harmless spike protein, enough to prepare the immune system to react if it later encounters the real virus.
Both vaccines must be kept frozen, Pfizer injected at ultra-low temperatures that make delivery difficult in poor or rural areas.
Other companies are working on their own mRNA candidates, including Germany’s CureVac, which started a major study in Europe.
PROTEIN VACCINES
The Novavax candidate is made differently, using what Fauci called a “more tested and proven” technology that only needs ordinary refrigeration. The Maryland company cultivates harmless copies of the coronavirus spike protein in the laboratory and mixes them in a chemical that boosts the immune system.
Novavax has already enrolled 15,000 people in an advanced study in Britain and 4,000 in South Africa. The largest and most recent study, funded by the United States government, will recruit volunteers from more than 115 locations in the United States and Mexico and will target high-risk older adults, along with volunteers from black and Hispanic communities who have been hit hard by the virus.
“We have to protect our community and our people,” said Rev. Peter Johnson, 75, a prominent civil rights activist in Dallas who was among the first volunteers.
Two-thirds of the participants will receive the vaccine and the remainder of the dummy injections, a variation on previous vaccine studies that gave half of their volunteers a placebo. This should help researchers recruit people who wonder whether it is better to participate in a study or wait for an existing injection to turn, said Dr. Gregory Glenn, head of research at Novavax.
For many people, this would be a long wait: doses of Pfizer and Moderna are scheduled first for healthcare professionals and nursing home residents, followed by people aged 75 and over and essential workers.
“If you wanted to limit your bets, for most people who are not in these high-risk groups, the shortest way to get the vaccine would be to sign up for a test,” said NIH director Dr. Francis Collins.
TROJAN HORSE VACCINES
The next big news about vaccines may come from Johnson & Johnson, which targets a single-dose COVID-19 vaccine.
Done in another way, it uses a harmless virus – a cold virus called adenovirus – to carry the spike gene into the body. In mid-December, J&J finished enrolling some 45,000 volunteers for a final stage study in the United States and in half a dozen other countries. Fauci expects initial results next month.
In Britain, regulators are also considering releasing a similar vaccine made by AstraZeneca and the University of Oxford.
Tests of the shots in Britain, South Africa and Brazil suggested that they are safe and partially protective – about 70%. But doubts remain about how well the vaccine works in people over 55 and how to interpret the results of a small number of people who received a different set of doses.
A US study on AstraZeneca injections is still recruiting volunteers; Fauci said the researchers hope he will provide a clearer answer.
Companies in China and Russia are also producing vaccines based on adenovirus and started administering them before the results of the final test were released. Argentina is expected to use the Russian vaccine soon.
“DEAD” VACCINES
Peak-focused vaccines are not the only option. Preparing vaccines by growing a disease-causing virus and then killing it is an even older approach that gives the body a preview of the germ instead of just that single peak protein.
China has three of these “inactivated” COVID-19 vaccines in final testing in several countries and has allowed emergency use in some people before the results. An Indian company is testing its own inactive candidate.
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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science. The AP is solely responsible for all content.