Modified vaccines ‘review’ expedited
EU seeks jab ‘overdrive’
LONDON, March 4, (AP): Regulators in the UK and four other countries have announced new rules to fast-track the development of modified COVID-19 vaccines to ensure drugmakers can move swiftly to target emerging variants of the disease.
Previously authorized vaccines that are modified to combat new variants “will not need a brand new approval or ‘lengthy’ clinical studies,” Britain’s Medicines and Healthcare Products Regulatory Agency said Thursday.
“The clear goal is that future vaccine modifications that respond to the new variants of coronavirus can be made available in the shortest possible time to UK recipients without compromising at any stage on safety, quality or effectiveness,” Dr. June Raine, the head of the agency, said in a briefing for reporters.
The new guidance is based on the model already used to modify the seasonal flu vaccine to keep up with annual changes in the virus and was issued jointly by regulators in the UK, Australia, Canada, Singapore and Switzerland. The US Food and Drug Administration and European Medicines Agency have issued similar guidance.
Under the new rules, developers will be required to provide “robust evidence” that modified COVID-19 vaccines produce a strong immune response to the variant, as well as data showing they are safe and meet quality standards.
This means developers will be required to carry out smallscale trials on a few hundred people, rather than the trials in tens of thousands of individuals that were required for initial approval, said Dr. Christian Schneider, the MHRA’s chief scientific officer.
“I’d like to emphasize that to date we don’t have evidence that the vaccines in use in the UK are significantly lacking in effectiveness,” Raine said.
The announcement comes amid concerns that the virus that causes COVID-19 may mutate to create new variants that are resistant to existing vaccines. The UK has banned direct flights from 33 countries in an effort to prevent variants first discovered in Brazil and South Africa from becoming established in Britain.
Variants
Vaccine makers have already been developing booster shots to target the new variants.
Moderna said Feb. 24 that it had shipped a variant-specific vaccine candidate to the US National Institutes of Health for review. The coronavirus pandemic has infected over 115 million people around the world and killed at least 2.5 million, according to Johns Hopkins University.
Meanwhile, slow off the blocks in the race to immunize its citizens against COVID-19, Germany faces an unfamiliar problem: a glut of vaccines and not enough arms to inject them into.
Like other countries in the European Union, its national vaccine campaign lags far behind that of Israel, Britain and the United States. Now there are growing calls in this country of 83 million to ditch the rulebook, or at least rewrite it a bit.
Germans watched with morbid fascination in January as Britain trained an army of volunteers to deliver coronavirus shots, then marveled that the UK - hit far worse by the pandemic than Germany - managed to vaccinate more than half a million people on some days.
The US drive-thru inoculation centers and the COVID-19 shots given out in American grocery store pharmacies drew bafflement in Germany - that is, until the country’s own plans for orderly vaccine appointments at specialized centers were overwhelmed by the demand.
Britain and the United States “had a much more pragmatic approach” to vaccination, said Hans-Martin von Gaudecker, a professor of economics at the University of Bonn. “What normally makes German bureaucracy stolid and reliable becomes an obstacle in a crisis and costs lives.”
The European Medicines Agency approved the AstraZeneca vaccine for all age groups, but several EU nations, including Germany, imposed tighter age limits.
With its stockpile of AstraZeneca vaccine doses set to top 2 million, Germany is looking to make more people eligible for the shots that have so far been restricted to a fraction of the population: people in the top priority group who are under 65.
France changed tactics earlier this week, allowing some people over 65 to get the AstraZeneca vaccine after initially restricting its use to younger people. Health Minister Olivier Veran said the shot would soon also be available to people over 50 with health problems that make them more vulnerable.
France, which at more than 87,000 dead has among the highest coronavirus tolls in Europe, had used only 25% of the 1.6 million AstraZeneca vaccines it has received as of Tuesday.
Restrictions
European nations’ age restrictions on AstraZeneca compounded problems caused by initial delivery delays and some public reticence toward the vaccine.
Yet data this week from England’s mass vaccination program showed that both AstraZeneca and the Pfizer-BioNTech vaccine were around 60% effective in preventing symptomatic COVID-19 in people over 70 after just a single dose. The analysis released by Public Health England, which hasn’t been peer reviewed yet, also showed that both vaccines were about 80% effective in preventing hospitalizations among people over 80.
Belgium and Italy, too, are loosening their age restrictions for the AstraZeneca vaccine as they scramble to confront a looming third spike in COVID-19 cases driven by more contagious virus variants.
In Italy, Premier Mario Draghi’s new government ousted the COVID-19 emergency czar this week and put an army general with expertise in logistics and experience in Afghanistan and Kosovo in charge of the country’s vaccination program.
Denmark, meanwhile, stands out as an EU vaccination success story. The Scandinavian nation leads the bloc’s vaccination tables along with tiny Malta and expects to vaccinate all adults by July - far ahead of the EU goal of 70% of adults vaccinated by September.
Rather than hold back doses for the required second shot, Danish health authorities followed the British model of using all available vaccines as they came in - an approach more EU countries are now considering.
And all of Denmark’s 6 million people have digital health records linked to a single ID number, allowing authorities to pinpoint exactly who is eligible for vaccination and reach out to them directly. British authorities also text people directly to set up shots.
“There are historical reasons why we don’t have a centralized register like in Denmark,” said von Gaudecker, citing Germany’s grim history of state oppression under Nazism and Communism.
“Of course a state can do terrible things with data,” he said. “But it can also potentially do great things with data.”
Better targeting available doses for those who need them is one way European countries hope to stay ahead of the virus in the coming months, as more contagious variants spread.
France and Spain plan to give just one shot of the two-dose vaccines to some people who have recovered from COVID-19, arguing that recent infections act as partial protection against the virus.
Italy, France and the Czech Republic are prioritizing vaccinations in outbreak hotspots. Hungary’s leader got a Chinese COVID-19 shot over the weekend and his country and Slovakia are buying Russia’s Sputnik V to supplement other vaccines delivered by the EU. Poland’s president has suggested that his country may follow Hungary’s lead in getting Chinese vaccines.