AstraZeneca PLC (Nasdaq: AZN) is contemplating another worldwide trial of its COVID-19 vaccine to reaffirm the 90% efficacy rate using a lower dosage, as per a report published by Bloomberg news. The British–Swedish multinational biopharmaceutical company and its partner for research, Oxford University, is confronting trial data about their potential COVID-19 vaccine AZD 1222 after they accepted a manufacturing fault.
The subsequent trial is anticipated to sort out ambiguity and clarity problems over its ongoing study. The stock closed at $52.61, almost flat from the previous close.
Cambridge, UK-based AstraZeneca’s CEO Pascal Soriot has clarified that the company might likely roll out a new study to assess the efficiency of a lower dose of its COVID-19 vaccine that achieved a better response than a full dosage.
Soriot said: “Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study…. but this one could be faster because we know the efficacy is high, so we need a smaller number of patients.”
Earlier last week, the potential COVID-19 vaccine (AZD 1222) was assessed to be 70% effective (on average) in a late-stage clinical trial in Brazil and the UK. In particular, the batch of volunteers who received half-dose demonstrated the efficacy of 90% compared to 62% efficacy when volunteers were treated with two full doses.
After publishing the clinical trial data, AstraZeneca and Oxford University acknowledged that a group of volunteers was unintentionally given half-doses, rather than a full dose, given the manufacturing procedures’ differences. Interestingly, government ministers and professionals in the UK have voiced their support for the COVID-19 vaccine from AstraZeneca and Oxford University after US-based professionals raised concerns.
Housing Minister Robert Jenrick tried to clear doubts about the vaccine by issuing the following statement: “I don’t think there is any reason to be unduly concerned. We have now written to the body that will independently assess the veracity and the safety of the vaccine.”
When queried about the trial, the UK government’s senior scientific advisor Patrick Vallance opined that emphasis should be on the reality that the vaccine performs as intended.
Vallance said: “The headline result is the vaccine works and that’s very exciting.”
Chief Medical Advisor Chris Whitty echoed the opinion of Vallance and said: “The key thing from our point of view is to leave this in the hands of the regulator … They will make an assessment with lots of data that is not currently in the public domain on efficacy and on safety.”
The UK government has asked the country’s drug regulator to assess whether the vaccine can be used temporarily, implying that it could be launched before the end of 2020. Britain intends to use nearly 4 million doses in the forthcoming month, but worries in the US could result in the launch’s postponement.
The efficacy rate of 70% is a mean of the efficacy rates from two trials. The first trial included a smaller batch of unintentionally subject people to a lower dose of the COVID-19 vaccine, resulting in a 90% efficacy. The larger batch, which received a higher dose, demonstrated only 62% efficacy.
Moncef Slaoui, Chief of the White House’s Operation Warp Speed, and many health experts in the US have raised concerns over the age group of volunteers who participated in the trial. Pointing that 90% efficiency was seen only for the age group with the lowest risk, i.e., 2,741 volunteers under 55.
John LaMattina, an ex-President of Pfizer Global R&D, opined that it is difficult to believe that the US FDA would endorse a vaccine when only 2,300 volunteers have received optimal dose. However, AstraZeneca brushed aside the criticism by stating that supervision is done by the external Data Safety Monitoring Board (DSMB), and the data published last Monday was only intermediate results, and more data would be available soon.
Furthermore, AstraZeneca has emphasized that “highest standards” were adopted, and additional studies will be carried out. It can be remembered that the company had stated that its vaccine could be transported and handled under a normal refrigerated environment (36-46 degrees Fahrenheit) for a minimum of six months and used under prevailing health setup. The company has also promised to supply the vaccine on a no-profit basis “for the duration of the pandemic.”
Meanwhile, Russia-based developers of COVID-19 vaccine Sputnik V tweeted that AstraZeneca should look at the option of trying its vaccine in combination with AZD 1222 to improve efficiency rate. As per intermediate results, the Sputnik V vaccine has an efficacy rate of 92%. The 125-year old Gamaleya Institute has stated: “Combining vaccines may prove important for revaccinations.”
The news of an additional vaccine trial is expected to turn the stock range-bound with a slight bearish bias.
The historical price chart indicates that the stock has closed below its 50-day moving average. Additionally, the MACD histogram has a negative reading. Furthermore, the stock is facing resistance at 57. The next support is anticipated only near 45. Therefore, we are expecting the stock to decline further in the short-term.
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