Covid-19 roundup: The pandemic bear — You think a vaccine and herd immunity are just months away? Dream on, says biotech analyst; plus more
You’ve all heard the rosiest scenarios by now.
Vaccines are racing through clinical development at unheard-of speed, helped along by regulators working round the clock to beat Covid-19. And manufacturers have been laying the groundwork for mass production ahead of Phase I results.
The first wave of jabs and meds could break in a matter of months. With the NIH endorsing such remarks as “We’ll have a vaccine by September,” everyone from lawmakers to investors and the general public have been willing to buy into the notion that salvation lies right around the corner.
Then along comes a prominent analyst to pour a bucket of cold water on your hope of turning the tide by Christmas.
SVB Leerink’s Geoffrey Porges took stock of the promise of global pandemic relief and offered to burst that little bubble for free.
For Porges, the only thing that lies around the corner is … another corner. And then more corners. The path to a vaccine is long and hard, he notes. And the reality of that should be factored in as we size up the future.
In our experience it is very unlikely that we will have a general use vaccine in the 6-18 month accelerated timeframe that is being discussed. We believe that a 2-3 year timeline is the most optimistic for seeing a general use vaccine introduced, and as importantly, in the remote possibility that an approved, effective, safe general use vaccine was available a year from now, it would still take several years to confer sufficient “herd immunity” to prevent endemic spread of COVID19. We believe that achieving herd immunity sufficient to prevent epidemic spread is likely to occur in 2023 or 2024, given a highly accelerated timeline for vaccine development including demonstration of safety and efficacy in humans, and then design, development and implementation of a mass immunization program sufficient to get to a 70-80% immune threshold.
And that, he adds, is his “optimistic” projection. It could be much, much worse.
Sure, there are more than 70 vaccine programs going on now. But for Porges, if you add it all up, it’s like handing someone a dart and giving them 1 chance to hit a bulls eye at 24 feet — 3 times the regulation distance. He’s also not enthusiastic that the closest vaccines to reality — like the mRNA vaccines — can pass muster quickly, as they are completely unproven.
Add to that a new virus we don’t completely understand and you get a better idea of where Porges is coming from.
We do have the luxury of many different shots on goal with 70+ programs underway (to mix our sporting metaphors), but each one of these only has the same low probability and most of them can’t deliver on the optimistic timelines now dominating policy maker’s and investor’s outlooks.
The only real shot at getting a vaccine into fast use is by requiring people to take a shot of something that no one knows the full story on — with safety and efficacy iffy at best, notes the analyst. And that includes immunizing low-risk people for the sake of the older generation.
So give it 2-3 years for an effective vaccine, then 1-3 years for herd immunity. — John Carroll
Alexion plots quick PhIII to evaluate whether Ultomiris can boost survival rates
Almost a month after indicating it’s looking into testing its star C5 inhibitor Soliris for hospitalized patients with Covid-19, Alexion is going straight into Phase III with its follow-up drug, Ultomiris. The study will involve around 270 patients suffering from severe pneumonia, acute lung injury or acute respiratory distress syndrome and investigate whether Ultomiris can help them survive past 29 days.
The decision was based on “early anecdotal information available from compassionate use cases in multiple countries” as well as preclinical data suggesting that inhibition of terminal complement can lower cytokine and chemokine levels, thereby reducing lung inflammation.
In the Phase III trial — which will include a control arm receiving best supportive treatment — investigators will also assess the need for mechanical ventilation, oxygenation, duration of ICU stay and hospitalization, in addition to safety as secondary endpoints. Meanwhile Alexion is still running an expanded access program in the US and France for Soliris. — Amber Tong
Society needs to pitch in to shore up drug, vaccine manufacturing
Apart from developing an efficacious and safe vaccine, a company’s ability to manufacture the vaccine swiftly is paramount. Experts, including NIAID director Anthony Fauci, have stressed that the best strategy is for makers to shore up manufacturing even before they have concrete evidence of efficacy so that vaccines can be deployed quickly and widely if proven to be safe and potent.
Now, chiefs of pharmaceutical companies are asking governments to work together and provide substantial funding to assist with shoring up production. “Industry alone can’t provide all the investment needed now for billions of doses,” Sanofi EVP David Loew said in an interview with the Financial Times.
Apart from vaccines, there is a global desperation for raw materials for existing treatments being repurposed and testing. Of particular concern are developing poorer nations, whose access to medical supplies is limited by scanter resources. Executives also worry that the Covid-19 situation will echo what happened in the aftermath of previous outbreaks, such as Ebola and the 2009 flu pandemic — as the dust began to settle, companies struggled to maintain funding to develop potential drugs and vaccines for future outbreaks after governments cut them off.
“The investment required is too large for any company,” said Takeda chief Christophe Weber to the FT. “Society will have to finance this huge investment. My fear is the same as after the flu pandemic, when everybody loses interest.” — Natalie Grover
Trump advisor Navarro asserts China is withholding data to win vaccine race
On Sunday, White House advisor Peter Navarro took to Fox News to accuse China of taking a suite of actions to worsen the ongoing coronavirus crisis.
“First of all, the virus was spawned in China. Second of all, they hid the virus behind the shield of the World Health Organization. The third thing they did was basically hoard personal protective equipment and now they’re profiteering from it,” Navarro said on Fox News program Sunday Morning Futures.
The outspoken critic of China, who has been tasked by President Trump to work on supply issues relating to the pandemic, on Monday suggested on Fox News that the country is withholding data about early coronavirus infections in order to be the first to develop a vaccine.
“One of the reasons that they may not have let us in and given us the data on this virus early, is they’re racing to get a vaccine and they think this is just a competitive business race, it’s a business proposition so that they can sell the vaccines to the world,” he said.
The race to develop a vaccine has heated up, with China’s CanSino as one of a handful of developers with a vaccine in human testing. — Natalie Grover
Brazil hydroxychloroquine trial suspended due to ethical concerns
A new study from Brazil, which suggested the combination of hydroxychloroquine and azithromycin had a significantly positive impact on early-stage suspected Covid-19 cases, was posted as a preliminary manuscript draft on Dropbox last week.
On Monday, the trial was suspended by the National Commission for Ethics in Research (Conep) after the agency discovered that testing was initiated before the company, a São Paulo-based hospital chain, received the greenlight to carry out the research. The researchers in charge were summoned for a hearing this Monday afternoon with the agency to provide clarification on suspected irregularities, according to a report.
There were a number of inconsistencies identified. For one, researchers had told Conep that patients with a confirmed diagnosis of Covid-19 would be included in the trial, but the manuscript released suggested that participants displaying flu-like symptoms without confirmed Covid-19 infections were included in the trial. Initially, the researchers also indicated the trial would enroll 200 participants, but the manuscript the number was closer to 700, the report said. — Natalie Grover
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