the Indian governmentThe position that it will consider the option of two full injections comes from the red flags raised by vaccine experts on the interim “positive” data, in light of AstraZeneca’s admission that there was an “inadvertent dosing error. “during global clinical trials. AstraZeneca He said the half-dose option was a case of serendipity, but that it stuck, as it was found to give better results than the full two-dose vaccine.
The limit for the effectiveness of the vaccine for the United States Food and Drug Administration (FDA), the federal regulator, is 50%.
To avoid controversy, Indian officials said the approved protocols for testing in India are for the option of two full injections and a 62% efficacy vaccine, once it passes regulatory scrutiny, it is good enough for your approval and use. In the immediate context, this could be suitable for emergency use if scientifically found to be satisfactory. An Indian Serum Institute The official said the Indian trials are proceeding smoothly. Questions about the data had an immediate resonance, as the outlet is considered a good option for India given the likely availability, price and early use.
“Let’s wait for the regulators to examine the data. Any call needs to be scientifically scrutinized, ”said Dr. VK Paul, head of the national expert group for vaccine administration. However, he said it was unscientific for vaccine manufacturers to put confidential data in the public domain. “This data is intended for the data security and monitoring board’s consideration and is highly confidential. These data are not intended for public debate, as they can create perceptions that may or may not be true, ”he added.
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An SII official, reacting to the reports, said: “We must be patient and not panic. Indian trials are running smoothly with strict adherence to all necessary processes and protocols. So far, there are no worries. However, we are reviewing the data that is available and will make further statements, if necessary. ” Commenting on the preliminary data from AstraZeneca, he added that “varying age groups with different dosage forms will result in slight variations and efficacy.” On Monday, AstraZeneca announced that the average efficacy of the two regimens is 70%.
While the race to come up with a vaccine could see drug companies make claims about their vaccines, Indian officials said the approved protocol for AstraZeneca for India makes no mention of administering half doses. Medicines regulator may consider emergency use authorization for the Pune-based Serum Institute of India (SII), a major manufacturing partner, if AstraZeneca gains UK regulator approval for two full doses and submits validated data scientifically to Indian agencies.
A Bloomberg The report said the firm was planning a new trial that, rather than adding an arm to an ongoing trial in the United States, would evaluate a lower dose that worked better than a full amount in the Astra studies. There have been reports that this dose works better among younger recipients.
Experts advised a cautious approach. “It would be prudent for the Serum Institute to focus on the clinical trials in India and make sure the study is conducted properly and transparently given the red flags. We need to better understand the efficacy and safety of the candidate vaccine given the two safety incidents and the apparent selection of data for the recent press release, ”said Dr. Anant Bhan, researcher and past president of the International Association for Bioethics.
“We have approved a clinical trial protocol with only two full doses. Also, we will give the approval after considering the global efficacy data along with the data generated from the immunogenicity studies being conducted by Serum Institute in India and for the latter, they are using only two full doses. Therefore, it is not a question of considering the data of a half dose and a full dose, unless the company makes a new application with a new protocol for it, ”a senior official told TOI.
“AstraZeneca’s misstep has put a the Serum Institutewheel of. Faced with overwhelming odds, it would have to prove that the vaccine it plans to mass-produce for AstraZeneca is actually as effective and safe as it was perceived to be. Since various competitors are breathing down his neck, he faces an unenviable task of gaining the trust of the public, ” said SP Kalantri, Professor of Medicine, MGIMS, Sevagram. “Evaluation of dosage and intervals is a key part of vaccine development, it should not be by accident,” said Dr. Gagandeep Kang of CMC Vellore.
Many global researchers and public health experts questioned the integrity of the results generated, although some still backed it up saying that none of the companies has submitted data to any regulator.
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