A massive US study of another COVID-19 vaccine candidate kicked off Monday as states continue to roll out scarce supplies of the first shots to a nation anxiously awaiting relief from the catastrophic outbreak.
Public health experts say more options in addition to the two vaccines now being provided – one made by Pfizer and its German partner BioNTech, the other by Moderna – are critical to getting enough photos for the country and the world.
The Novavax Inc. candidate is the fifth to reach the final testing phase in the United States. It takes about 30,000 volunteers to prove that the shot – a different kind from its Pfizer and Moderna competitors – actually works and is safe.
“If you want to have enough vaccine to vaccinate all the people in the US you would want to vaccinate – up to 85% or more of the population – you need more than two companies,” Dr. Anthony Fauci, America’s top infectious disease expert, told The Associated Press Monday.
According to the COVID Tracking Project, the coronavirus is responsible for approximately 1.8 million deaths worldwide, including more than 330,000 in the US This was the deadliest month of the outbreak in the US to date, with approximately 65,000 deaths in December so far. The country has repeatedly recorded more than 3,000 deaths per day in recent weeks.
And the US could go through a terrible winter: Despite warnings to stay home during Christmas time and avoid others, nearly 1.3 million people passed through the country’s airports on Sunday, the highest total in one day since the crisis nine hit in the US months ago. .
Trump administration’s Operation Warp Speed expects to have shipped 20 million doses of the Pfizer and Moderna vaccines to states by early January, less than originally estimated to the frustration of states and health officials who tried to schedule the shooting.
There is no real-time tracking of how quickly people receive 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had reports of more than 2.1 million vaccinations from 11.4 million doses sent – but the agency knows that number is out of date. Reports from vaccine suppliers can take days to trickle in and be added to the site.
“Just because a vaccine arrives doesn’t mean we can set up a clinic on site,” said Jenny Barta, a public health officer in Carlton County, Minnesota.
But on Tuesday, her agency wants to vaccinate 100 people at a drive-thru health care provider clinic that Barta hopes could become a model for larger attempts at mass vaccination. Nurses send the vaccine to cars parked in a snow plow garage. Once the drivers have taken their photos, they will wait in parking lots to make sure they don’t have an allergic reaction before heading home.
“By vaccinating one person at a time, we are working our way out of this pandemic,” she said.
Yet another concern hanging over the vaccination group: Will shots block a new variant of the coronavirus that emerged in Britain and could spread more easily? Fauci said data from Britain indicates that the vaccines will still protect against the virus, but that researchers at the National Institutes of Health will certainly be “looking very closely at them.”
A look at the front runners in the global vaccination race:
GENETIC CODE VACCINES
The US based the rollout of the Pfizer-BioNTech vaccine and a similar vaccine from Moderna and the NIH in an emergency on studies suggesting that they are both about 95% effective. Europe started its first vaccinations with the Pfizer injection last weekend and will decide on January 6 whether Moderna’s will be added.
These recordings were made with a brand new technology that injects a piece of genetic code for the spike protein that envelops the coronavirus. That messenger RNA, or mRNA, prompts the body to produce some harmless spike protein, enough to stimulate the immune system to respond when it later encounters the real virus.
Both vaccines must be kept frozen, the Pfizer firing at ultra-low temperatures that make delivery to poor or rural areas difficult.
Other companies are working on their own mRNA candidates, including Germany’s CureVac, which has started a major study in Europe.
PROTEIN VACCINES
The Novavax candidate was created differently, using what Fauci called a “more proven” technology that requires only ordinary cooling. The Maryland company grows harmless copies of the coronavirus spike protein in the lab and mixes it into an immune-boosting chemical.
Novavax has already enrolled 15,000 people in late-stage research in Great Britain and 4,000 in South Africa. The latest and largest study, funded by the US government, will recruit volunteers in more than 115 locations in the US and Mexico and target high-risk older adults, along with volunteers from black and Hispanic communities, who have been severely affected by the virus.
“We must protect our community and our people,” said Pastor Peter Johnson, 75, a prominent Dallas civil rights activist who was one of the first volunteers.
Two-thirds of the participants will be given a vaccine and the rest will be given dummy shots, a twist from previous vaccine studies that gave half of their volunteers a placebo. That should help researchers recruit people who wonder whether it’s better to participate in a study or wait their turn for an existing shot, said Dr. Gregory Glenn, Novavax’s chief of research.
For many people, that would be a long wait: The Pfizer and Moderna shots are planned first for health workers and nursing home residents, followed by those over 75 and older and essential workers.
“If you’d like to hedge your bets, for most people who aren’t in these high-risk groups, the shortest route to getting the vaccine would be to sign up for a trial,” said NIH director Dr. Francis Collins.
TROJAN HORSE VACCINES
The next big vaccine news may come from Johnson & Johnson, which is aiming for a single-dose COVID-19 vaccine.
It’s made in yet another way, using a harmless virus – a cold virus called adenovirus – to deliver the spike gene into the body. In mid-December, J&J completed the enrollment of about 45,000 volunteers for a final phase in the US and half a dozen other countries. Fauci expects the first results sometime next month.
In the UK, regulators are also considering releasing a similar vaccine from AstraZeneca and Oxford University.
Tests of the shots in Great Britain, South Africa and Brazil suggested they are safe and partially protective – about 70%. But questions remain about how well the vaccine works in people over 55 and how to interpret the results of a small number of people who receive a different series of doses.
A US study of the AstraZeneca recordings is still recruiting volunteers; Fauci said researchers hope it will provide a clearer answer.
Companies in China and Russia also produce adenovirus-based vaccines and began administering them before the results of the latest tests became known. Argentina is expected to use the Russian vaccine soon.
“KILLED” VACCINES
Spike-targeted vaccines aren’t the only option. Creating vaccines by growing a disease-causing virus and then killing it is an even older approach that gives the body a taste of the germ itself rather than just that one spike protein.
China has three such “inactivated” COVID-19 vaccines in final testing in several countries and has allowed emergency use in some people before results were achieved. An Indian company is testing its own inactivated candidate.
___
The Associated Press’s Health and Science Department is supported by the Howard Hughes Medical Institute’s Science Department. The AP is solely responsible for all content.