Northwest Arkansas Democrat-Gazette
CDC adjusts rules on mixing vaccines, says tweak not ideal
The Centers for Disease Control and Prevention has quietly changed its recommendations for coronavirus immunizations to allow patients to switch authorized vaccines between the first and second doses in “exceptional situations,” and to extend the interval between doses to six weeks, even though such changes have not been studied in large clinical trials.
The new guidelines were posted on the agency’s website Thursday with little public notice. With the possibility of vaccine shortages on the horizon and little expectation that the supply can be increased before April, the changes may offer a way to vaccinate more people — a high priority for President Joe Biden, who outlined his national covid-19 strategy Thursday.
A CDC spokeswoman, Kristen Nordlund, said the agency’s “intention is not to suggest people do anything different but provide clinicians with flexibility for exceptional circumstances.”
Dr. Anthony Fauci, the president’s special adviser for covid-19, has repeatedly advised against delaying the second dose or making any other changes in vaccination protocol without the data to support them.
Earlier this month, Britain quietly updated its playbook to allow for a mix-and-match regimen if the second dose of the vaccine a patient originally received isn’t available or if the manufacturer of the first shot isn’t known. Some scientists questioned the move at the time, saying Britain was gambling with its new guidance.
In the United States, two vaccines have emergency federal authorization — one by New York-based Pfizer and BioNTech, its German partner; the other by Massachusetts-based Moderna.
They rely on the same mRNA technology, and both call for two doses. Until now, the CDC has strictly adhered to the recommendations from its Advisory Committee on Immunization Practices, which specifically stated that the vaccines were not to be mixed.
The updated CDC guidance still says the authorized vaccines are “not interchangeable with each other or with other COVID-19 vac- cine products.” The agency put the word “not” in bold on its website, and noted that the safety and efficacy of mixing doses has not been studied.
But “in exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available,” the guidelines add, any available mRNA vaccine can be used for the second dose.
With respect to dosing, the guidance says the second dose should be administered as closely as possible to the recommended interval — three weeks for the Pfizer-BioNTech vaccine and four weeks for the Moderna version. But if that is “not feasible,” the agency wrote, the interval may be extended to six weeks.
The pace of vaccination is critical not just to curbing disease and death but also to heading off the effect of more infectious forms of the virus. The CDC has warned that one variant, which is thought to be 50% more contagious, might become the dominant source of infection in the United States by March.
Although public health experts are optimistic that the existing vaccines will be effective against that variant, known as B.1.1.7, it may drive up the rate of new cases if enough people remain unvaccinated.
At a White House briefing Thursday — his first since November — Fauci said experts are particularly concerned about new variants of the virus in South Africa and Brazil, which have not yet reached the United States. He said vaccines still appear to be effective against those variants, but they may sidestep the immune system to some degree, making it all the more urgent for people to be vaccinated.
“Replicating viruses don’t mutate unless they replicate,” Fauci said, “and if you can suppress that by a very good vaccine campaign, then you can actually avoid this deleterious effect that you might get from the mutations.”
Federal health officials and corporate executives agree that it will be impossible to increase the immediate supply of vaccines before April because of lack of manufacturing capacity. And the current vaccination effort, which had little central direction under President Donald Trump’s administration, has so far sown confusion and frustration. Some localities are complaining that they are running out of doses, while others have unused vials sitting on shelves.
According to a senior administration official, Pfizer-BioNTech and Moderna are on track to deliver up to 18 million doses a week. Together, they have pledged to deliver 200 million doses by the end of March.
A third vaccine maker, Johnson & Johnson, is due to report the results of its clinical trial shortly. If approved, that vaccine would also help shore up production. If all of that supply were used, the nation could average well over 2 million shots a day.
In April and beyond, the outlook brightens. Pfizer and Moderna have each committed to supply another 100 million doses by the end of July. The companies may be able to provide even more.
A week ago, Pfizer and BioNTech increased their global production target for the year to 2 billion doses from 1.3 billion doses.
AROUND THE WORLD
Nearly a year to the day after the Chinese city of Wuhan went into lockdown to contain a virus that had already escaped, Biden began putting into effect a new war plan for fighting the outbreak in the U.S.
Germany topped 50,000 deaths, and Britain closed in on 100,000.
Wuhan has largely returned to normal.
The anniversary of the lockdown today comes as more contagious variants spread and efforts to vaccinate people have been frustrated by disarray and limited supplies in some places. The scourge has killed more than 2.1 million people worldwide.
In the U.S., which has the world’s highest death toll at more than 413,000, Fauci said a lack of candor about the threat under Trump probably cost lives. He told CNN that the Trump administration delayed getting sound scientific advice to the country.
“When you start talking about things that make no sense medically and no sense scientifically, that clearly is not helpful,” Fauci said.
Biden signed a series of executive orders Thursday to mount a more centralized attack on the virus and has vowed to vaccinate 100 million people in his first 100 days, a number some public health experts say is not ambitious enough.
Dr. Eric Topol, head of the Scripps Research Translational Institute, said the U.S. should aim to vaccinate 2.5 million people a day.
“This was already an emergency,” Topol said, but with more contagious mutations of the virus circulating, “it became an emergency to the fourth power.”
In Britain, where a more transmissible variant of the virus is raging, the death toll topped 96,000, the highest in Europe. And the government’s chief scientific adviser warned that the mutated version might be deadlier than the original.
Germany this week extended its lockdown until Feb. 14 amid concern about the mutant viruses.
Some nations are imposing or considering new travel restrictions. France said it will require a negative test from travelers arriving from other European Union countries starting Sunday. Canada said it may force visitors to quarantine in a hotel at their own expense upon arrival.
Canadian Prime Minister Justin Trudeau warned the country: “No one should be taking a vacation abroad right now. If you’ve still got one planned, cancel it. And don’t book a trip for spring break.”
In another apparent setback, AstraZeneca said it will ship fewer doses of its vaccine than anticipated to the 27-country EU because of supply chain problems.
Amid the crisis, Japan insists that it will hold the postponed Olympics in July. Many experts believe that to pull that off, the nation will have to vaccinate all of its 127 million citizens, an effort that may not even begin until late February.
The rollout of shots in the U.S. has been marked by delays, confusion and, in recent days, complaints of vaccine shortages and inadequate deliveries from the federal government as states ramp up their vaccination drives to include senior citizens as well as teachers, police and other groups.
At the same time, the CDC reported Friday that of nearly 40 million doses distributed to the states so far, just 19 million have been dispensed.
Why there are reports of shortages when so many doses are apparently going unused is not entirely clear. But some vaccination sites are believed to be holding back large quantities to make sure that people who got their first shots receive the required second ones on schedule a few weeks later.
At the rate vaccines are being delivered, Alabama officials said it would take two years to vaccinate all adults in the state of 5 million people.
“Every state had the idea that they were going to get much more vaccine than they ultimately got,” said Scott Harris, head of the state Department of Public Health. “There just wasn’t enough vaccine to go around.”
Louisiana said it plans to set up mass vaccination events but can’t do so until it receives larger quantities of vaccine. The state said it has been receiving about 60,000 doses weekly for the past few weeks and was told by federal officials to expect similar allocations for the next month or so.
“We all are asking for the exact same thing,” Gov. John Bel Edwards said of the nation’s governors. “We want more vaccine as soon as we can possibly get it, and we want more lead time to know how many doses we’re going to get so that we can do a better job of planning at the state level.”
In Boston, nearly 2,000 doses were spoiled at a Veterans Affairs hospital after a contractor accidentally unplugged a freezer.
Biden pledged to set up Federal Emergency Management Agency mass vaccination sites, but some states said they need more vaccine, not more people or locations to administer them.
“We stand ready, willing and able to handle it,” Florida Gov. Ron DeSantis said. Rather than setting up new sites, “I would take all that energy, and I would put that toward more supply of the vaccine.”
COVAX EFFORT
Pfizer on Friday committed to supply up to 40 million doses of its vaccine this year to a World Health Organization-backed effort to get affordable shots to poor and middle-income countries.
The deal is a boost to the global program known as COVAX, as wealthy nations have snapped up most of the millions of coming shots.
The commitment, announced at a virtual news conference held by the Geneva-based WHO, is seen as important because Pfizer and BioNTech last month won the first vaccine emergency authorizations from WHO and the U.S. Food and Drug Administration.
Earlier this week, WHO Director-General Tedros Adhanom Ghebreyesus criticized drugmakers for seeking profits from the pandemic and mostly supplying wealthy countries.
Pfizer’s 40 million doses — for a vaccine requiring two doses — are a tiny sliver of what’s needed for COVAX, which aims to vaccinate billions of people in 92 low- and middle-income countries.
During Friday’s news conference, Tedros said Pfizer’s commitment and about 150 million doses of the vaccine developed by AstraZeneca and Oxford University could enable COVAX to begin delivering doses in February. He said the global program is on track to deliver by year’s end 2 billion doses of vaccines previously pledged by AstraZeneca and other vaccine producers.
Pfizer had not previously committed to providing its vaccine to poor countries without making a profit during the pandemic, as a couple of rivals have.
However, Pfizer and BioNTech said they would provide their vaccine to COVAX at an undisclosed “not-forprofit price.” The companies still must execute a supply agreement covering distribution, but the doses are to be delivered throughout the year, starting in February.
“Today, we are proud to have this opportunity to provide doses that will support COVAX efforts toward vaccinating health care workers at high risk of exposure in developing countries and other vulnerable … populations,” Pfizer Chief Executive Officer Albert Bourla said.
Dr. Seth Berkley, CEO of the alliance that is leading procurement and delivery of vaccines for COVAX, called the deal “a major step forward for equitable access to vaccines.”