Northwest Arkansas Democrat-Gazette
5th vaccine hits final test stages
30,000 volunteers needed for trials of Novavax shots
A huge U. S. study of another covid-19 vaccine candidate got underway Monday as states continue to roll out scarce supplies of the first shots to a nation anxiously awaiting relief from the pandemic.
Public health experts say more options in addition to the two vaccines now being dispensed — one made by Pfizer and its German partner BioNTech, the other by Moderna — are critical to amassing enough shots for
the country and the world.
The candidate made by Novavax Inc. is the fifth to reach final-stage testing in the United States. Some 30,000 volunteers are needed to prove whether the shot — a different kind than its Pfizer and Moderna competitors — really works and is safe.
“If you want to have enough vaccine to vaccinate all the people in the U.S. who you’d like to vaccinate — up to 85% or more of the population — you’re going to need more than two companies,” Dr. Anthony Fauci, the top U.S. infectious disease expert, told The Associated Press on Monday.
The coronavirus is blamed for about 1.8 million deaths worldwide, including more than 330,000 in the U.S. This has been the deadliest month of the outbreak in the U.S. yet, with about 65,000 deaths in December so far, according to the COVID Tracking Project. The nation has repeatedly recorded more than 3,000 dead per day over the past few weeks.
And the U.S. could be facing a terrible winter: Despite warnings to stay home and avoid others during the holiday season, nearly 1.3 million people went through the nation’s airports on Sunday, the highest one-day total since the crisis took hold in the U.S. nine months ago.
The Trump administration’s Operation Warp Speed expects to have shipped 20 million doses of the Pfizer and Moderna vaccines to states by the beginning of January, fewer than originally estimated to the frustration of states and health officials trying to schedule the shots.
There is no real- time tracking of how quickly people are getting 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reports of more than 2.1 million vaccinations out of 11.4 million doses shipped — but the agency knows that count is outdated. It can take days for reports from vaccine providers to trickle in and get added to the site.
“Just because a vaccine arrives doesn’t mean we can put an on-the-spot clinic up and running,” said Jenny Barta, a public health official in Carlton County, Minn.
But today, her agency aims to vaccinate 100 people in a drive-thru clinic for emergency medical workers that Barta hopes could become a model for larger attempts at mass vaccination. Nurses will wheel vaccine to cars lined up in a county-owned snowplow garage. Once the drivers get their shots, they will wait in parking spaces to be sure they don’t have an allergic reaction before heading home.
“Vaccinating one individual at a time is how we’re going to work our way out of this pandemic,” she said.
NOVAVAX CANDIDATE
The Maryland-based biotech firm Novavax, which has never brought a vaccine to market before, received up to $1.6 billion from the federal government’s Operation Warp Speed this summer to expedite development. The company reported robust results in earlier phases of its trial, showing that the vaccine prompted strong immune responses in monkeys and people.
The company began a Phase 3 trial of 15,000 people in Britain in September and expects to report preliminary results from that study in the first quarter of next year. It had intended to start its U.S. trial in October but delayed it because of manufacturing problems.
The Novavax vaccine works differently than the ones by Pfizer and other companies that have already been shown to be effective. It contains artificially-produced viral proteins, along with an immune-boosting compound derived from the soapbark tree.
The Novavax vaccine must be kept refrigerated but does not require freezing, making its storage easier than the Moderna and Pfizer-BioNTech vaccines, which have to be transported at ultracold temperatures.
Three other protein-based coronavirus vaccines are also in Phase 3 trials in Australia, Canada and India.
Novavax will run its trial at 115 sites in the United States and Mexico, enrolling as many as 30,000 people. Two-thirds will receive the experimental vaccine, and the rest a placebo. Novavax said it would recruit a diverse group, including Black and Hispanic volunteers. They plan for one-quarter of their participants to be older than 65.
“With the covid-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” Stanley Erck, president and chief executive of Novavax, said in a statement.
ANTI-EVICTION LEGISLATION
Separately, The New York state Legislature convened Monday to pass one of the most comprehensive anti-eviction laws in the nation, as the state contends with high levels of unemployment and a pandemic that has taken 37,000 lives statewide.
For months, tenants and advocacy groups have been dreading the end-of-year expiration of eviction bans that have kept people in their homes despite their inability to pay rent. Under the new measure, landlords would be barred from evicting most tenants for at least another 60 days.
A tenant in danger of being kicked out of a home could submit a document stating financial hardship related to the coronavirus to postpone an eviction.
The legislation would also make it harder for banks to foreclose on smaller landlords who are themselves struggling to pay bills. But advocacy groups for landlords said the bill could leave many in a lurch.
The Legislature convened an unusual special session between Christmas and New Year’s to pass the measure, acting quickly because the governor’s executive order barring many evictions is expiring on Dec. 31.
New York Gov. Andrew Cuomo said he will sign the measure, which would go into effect immediately.
The state’s emergency action comes after President Donald Trump on Sunday signed a $900 billion relief package, which included $1.3 billion in rental relief for New Yorkers — and two days after unemployment benefits expired for millions of Americans. The state and federal legislation speak to the precarious financial situation facing millions of Americans, nine months into the pandemic.
In New York state, eviction proceedings have continued, but landlords have largely been barred from physically removing tenants from their homes. A smattering of evictions resumed in October, particularly for those tenants who were unable to convince judges that their financial hardships were related to the coronavirus. Tenants whose cases revolved around disputes other than nonpayment of rent could also be evicted.
As of late November, there have been 38 requests for eviction warrants in New York City, according to a recent analysis by the New York University Furman Center.