Update (1200ET): Despite AstraZeneca releasing its revised trial data earlier, Denmark has decided to extend its pause on the AstraZeneca jab.
On March 11, Denmark joined Norway, Austria, Italy and Iceland to suspend the use of the vaccine after reports of blood blots.
Originally the rollout of the coronavirus jab was paused for 14 days as a precautionary measure but Danish officials said on March 25 that this has been extended by three weeks as they conducted their own investigations.
Most European countries resumed the shots after the EU's medicines watchdog deemed it safe and effective.
In more bad news for the EU, Reuters reports that Novovax is delaying a deal to supply jabs to the Continent once its vaccine regulator decides to approve the jabs.
Following the release of the updates trial data earlier today, the FT reported that AstraZeneca is working on creating a vaccine nasal spray. According to the FT, Oxford, AstraZeneca's partner in developing the vaccine, has started advertising for participants for a trial of the nasal spray vaccine. The phase 1 trial will involve about 30 healthy adults aged up to 40 and will study the safety of the formulation, according to a recruitment sheet seen by the paper. It could begin as early as next week. Participants will receive at least one intranasal dose of the vaccine; and half will randomly receive a booster dose. The study will take about four months to finish.
Finally, in other vaccination news, Pfizer's revealed just minutes ago that it would soon start trialing the COVID vaccine on children younger than 12. This comes after a trial on children aged 12 to 15 went well. The trial’s first participants, a pair of 9-year-old twin girls, were immunized at Duke University in North Carolina on Wednesday. Results from the trial are expected in the second half of the year, and the company hopes to vaccinate younger children early next year, according to the New York Times.
But by far the biggest news comes out of India, which on Thursday imposed a de facto ban on vaccine exports. That's a huge problem for dozens of developing nations, as well as the WHO's Covax program. The Serum Institute of India, the largest manufacturer of vaccines in the world and Covax's biggest supplier, has reportedly been told to halt exports and that the measures could last as long as two to three months, according to two people familiar with the situation. Gavi, the UN-backed international vaccine alliance, immediately warned that the controls would have a direct impact on the Covax scheme
The European Commission is holding talks Thursday about whether to impose similar restrictions, although Brussels seemed yesterday to be on the cusp of a deal with the UK to ensure "reciprocity" in vaccine supplies, per the FT.
The Serum Institute is contracted to manufacture 550MM AstraZeneca jabs and 550MM Novavax jabs solely for Covax in 2021 and 2022. That accounts for 80% of the facility’s currently signed contracts according to data from earlier this month.
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Update (1000ET): More holdouts have decided to allow AstraZeneca jabs to be used on patients once again Thursday morning, with Sweden ending its safety probe. Vaccinations will move forward, including for people aged 65+.
- SWEDEN TO RESUME ASTRAZENECA COVID-19 VACCINATIONS - HEALTH AGENCY
- RECOMMEND ASTRAZENECA COVID-19 VACCINE FOR PEOPLE AGED 65 AND ABOVE
- RECOMMENDS EXTENDING PAUSE ON VACCINATIONS FOR YOUNGER PEOPLE
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Earlier this week, AstraZeneca managed to destroy the last remaining shreds of its credibility by prematurely releasing an analysis of its COVID vaccine Phase 3 trial data, drawing an uncomfortably public rebuke from an American oversight board tasked with regulating the trials. In response, the company acknowledged that the data it had just released was based on an interim analysis, and promised to re-release its final results later in the week.
The company made good on its promise early Thursday morning, when it re-published the trial data with one notable tweak: the jab, which was initially touted as 79% effective, is now 76% effective. Although the company's claim that the jab is "100% effective" against serious disease was unaltered (scientists counted eight severe cases during the trial, all among trial participants who received the placebo). The data included 190 confirmed cases of COVID among the trial participants - 49 new cases that weren't included in the data released Monday. On top of this, the company said there are 14 "possible or probable cases to be adjudicated so the total number of cases and the point estimate may fluctuate slightly."
The 76% number results from including newer infections among the 30K+ trial participants (trials were conducted in the US, as well as Chile and Peru). AZ also said the vaccine was 85% effective in preventing sickness among adults aged 65+, which is 5 percentage points higher than the 80% number it reported Monday.
While the revision is the latest reminder that the efficacy numbers touted by vaccine-makers are effectively meaningless, Reuters reported that the restatement of the AZ trial results will "go a long way to putting the vaccine back on track for gaining U.S. emergency use authorization."
"The vaccine efficacy against severe disease, including death, puts the AZ vaccine in the same ballpark as the other vaccines," said William Schaffner, an infectious disease expert from the Vanderbilt University School of Medicine, adding that he expects the shot to gain US approval.
AstraZeneca said the latest data has been presented to the independent trial oversight committee, the Data Safety Monitoring Board, and it plans to submit the analysis for peer-reviewed publication in the coming weeks.
"The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults," Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said in a quote included with the press release.
One top AZ executive said during an appearance on CNBC earlier this week that the company intends to apply for approval in the US during the first half of April. Europe, meanwhile, the nation of Denmark extended its suspension of the AstraZeneca jabs as local public health officials take a closer look at rare blood clots that appeared in a small handful of patients. The clots led to notable illnesses and a death among a trio of Norwegian health-care workers, and cases have also been reported in Austria, Italy, the Netherlands and elsewhere. Canada's health department on Wednesday became the latest western government to reiterate that it believes the vaccine is "safe" - though it also updated its label to warn about the risk of potentially deadly blood clots in patients with low blood-platelet counts.