Covid-19 roundup: AstraZeneca ships first COVAX doses as Canada recommends against 65+ use; Inovio, still stuck in PhIII, to respond to FDA in May
AstraZeneca’s Covid-19 vaccine has had a bumpy ride, but the prominent drugmaker is ready to start supplying their shots to COVAX.
The first doses of the AstraZeneca/Oxford vaccine were shipped to Ghana and Cote D’Ivoire, AstraZeneca announced Tuesday, with more set to begin arriving this week in the Philippines, Indonesia, Fiji, Mongolia and Moldova. For many of these countries, these doses represent their first Covid-10 vaccines, AstraZeneca said.
Public documents from mid-January released by Gavi, one of the organizations behind the COVAX effort, showed AstraZeneca and the Serum Institute have teamed up to provide 550 million shots. AstraZeneca itself is also giving another 170 million doses on its own.
Tuesday’s announcements comes a few days after Canada authorized the vaccine for use in adults older than 18. But not all has been peachy up north, with the country’s immunization advisory panel Monday recommending against using the shot to inoculate individuals older than 65, Reuters reported, citing a lack of efficacy information in that age group.
In its decision to greenlight the shot Friday, the Canadian drug regulator Health Canada said there are too few data to estimate how effective the shot could be among the 65-and-up age group. But it also noted “emerging real world evidence” in places using the shot, such as Scotland, suggests a potential benefit and no safety concerns.
AstraZeneca has encountered significant headwinds in its efforts to develop a Covid-19 vaccine. They were the first company to report a severe adverse event in one of their Phase III trials back in September, when a healthy British volunteer in the vaccine arm developed what was thought to be a rare neurological disorder.
The setback caused a global trial hold, and while it resumed quickly overseas, the trial took longer to get going again in the US. Britain and the EU have since authorized the shot for use, but it’s still awaiting the green light stateside.
But those authorizations haven’t lifted the drugmaker’s struggles, either. Tensions between AstraZeneca and EU have spilled over into public view, with both parties trading blows after the company said it wouldn’t be able to deliver the amount of vaccines promised in its contracts.
Some EU members, such as Italy, have questioned whether they’re allowed to sue AstraZeneca for reneging on its deal. But when the EU accidentally published the company’s contract with redactions that were easily removed by internet sleuths and German journalists, the text appeared to back up CEO Pascal Soriot’s claim that the shots promised fell under a “best effort” clause, forcing the EU into apologizing.
On top of that, people in countries where the AstraZeneca shot has been authorized are reportedly shunning the vaccine in favor of mRNA-based shots with higher topline efficacy levels.
Inovio won’t respond to FDA until May as PhIII still under hold
Inovio’s vaccine is still on partial clinical hold by the FDA, and it doesn’t appear that the hold is going away anytime soon.
In a 10-K filing submitted to the SEC on Monday, Inovio said they are planning to respond to regulators in May, roughly eight months after the agency pressed the pause button on their INO-4800 program. That communication would be followed by another 30-day period to see what the FDA has to say about any potential questions.
And they readily admit that their efforts may end up being fruitless.
“We do not know whether our planned Phase 3 clinical trial will begin on time or be completed on schedule, if at all,” Inovio wrote in the 10-K.
The FDA placed the hold on the Phase III portion of a Phase II/III trial in September due to questions about the device that will be used to deliver Inovio’s shot directly to the skin. According to an Inovio statement from December, the company plans on answering those remaining questions in the Phase II part of the study.
In January, Inovio partnered with Advaccine Biopharmaceuticals Suzhou to develop and commercialize the vaccine candidate in China, Hong Kong, Taiwan and Macau. In addition to $3 million upfront, Advaccine promised up to $108 million in milestone payments.
But the vaccine setbacks have not hurt Inovio’s cash flow. In a fourth-quarter and full-year earning report released Monday, the company said it raised $454 million in 2020.
Novavax asks FDA to consider global data
With three vaccines now authorized for use in the US, Novavax has reportedly approached the FDA to accelerate its path to become the fourth.
The biotech’s CEO Stanley Erck has asked regulators to consider trial data from the UK and South Africa as part of its EUA, according to a Yahoo! Finance report Monday, saying that waiting for US results would delay a decision by a “couple of months.” Erck made the comments in an earnings call Monday afternoon, and said he hopes Novavax will have shipped 110 million vaccine doses by July.
He separately told Yahoo! Finance that the FDA has done this before and hopes it can do so in this instance as well.
Erck compared the US authorization process to that in the UK, where regulators accept data on a rolling basis. British officials are set to analyze their global Phase III trial data by the end of the month, which showed in January the shot was 89.3% effective in the UK, but only 49.4% effective in the trial’s South Africa arm.
If all goes well in Britain, the country could authorize the vaccine in May, Erck said.
Novavax’s US trial only recently completed its 30,000-patient enrollment after multiple delays, however. In the meantime, the company is looking to ramp up production of its shots, and last month upped its commitment to COVAX to provide 1.1 billion shots to the global vaccine equity effort. Having partnered already with several global manufacturers, Novavax is aiming to reach full production capacity — 2 billion shots per year — by mid-2021.
The Covid-19 pandemic has offered Novavax the best financial news it’s had in years thanks to a $1.6 billion Warp Speed contract, having teetered on insolvency prior to 2020. Novavax $NVAX shares traded below $4 apiece at the end of 2019, but since then have risen nearly 6,700%.
Fauci pushes back on ‘first shots first’ push
After some debate that the US should undertake a “first shots first” strategy, in getting first vaccine doses out to as many people as possible, NIAID chief Anthony Fauci pumped the brakes Monday evening.
Fauci said the US government will continue its two-shot dosing plan for the Pfizer/BioNTech and Moderna vaccines, per the Washington Post. He noted that while the strategy has ostensibly worked in Britain, it wouldn’t make sense to do so in the US.
Not only would getting out more first doses leave people less protected from the virus, Fauci said, it would enable variants to spread and continue to feed vaccine hesitancy across the country. He cited research that showed one shot of the mRNA-based vaccines may not provide enough protection from the coronavirus variant that first emerged in South Africa.
“We’re telling people [two shots] is what you should do … and then we say, ‘Oops, we changed our mind’?” Fauci told WaPo. “I think that would be a messaging challenge, to say the least.”
The “first shots first” push gained traction over the weekend following the FDA’s authorization of J&J’s single-shot vaccine. Some public health experts have been urging the US to follow this strategy in order to offer at least some protection to a greater number of people, and on Monday two Democratic senators called on the Biden administration to begin such efforts.
J&J’s vaccine authorization has also driven concerns over the rise of a potential two-tiered distribution system, according to WaPo, where the easier-to-store J&J shot is given to places typically harder to reach. While those decisions make logistical sense, it could end up leaving marginalized communities getting what they think is an inferior product due to lower topline efficacy results, the report said.
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