AstraZeneca Resumes Its COVID-19 Vaccine Trials In The U.K.
Drugmaker AstraZeneca announced Saturday that its COVID-19 vaccine studies have resumed in the United Kingdom, though not yet in the United States. The vaccine trials had been placed on hold around the world earlier in the weekafter a U.K. participant in one of the studies developed a neurological illness.
The candidate vaccine was developed by the University of Oxford along with AstraZeneca. The goal of the large studies is to see whether the vaccine is capable of preventing COVID-19 and whether it is safe.
Although initial studies didn't reveal serious side effects from the vaccine, rare complications of any vaccine, if there are any, may not turn up until it has been administered to thousands, or tens of thousands of people.
On Sunday, AstraZeneca says,all studies around the world of this particular candidate vaccine were paused after one volunteer in the U.K. developed symptoms consistent with transverse myelitis, an inflammation of the spinal cord that can cause paralysis.
According to a statement Saturday from the drug company, the studies were paused "to allow review of safety data by independent committees, and international regulators."
The statement goes on to say that the committee has concluded its investigations and advised the Medicines Healthcare Products Regulatory Authority, the U.K.equivalent of the Food and Drug Administration, that trials in the U.K. are safe to resume.
In an email to NPR Saturday, an AstraZeneca spokesperson said, "The company will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume."
AstraZeneca said it cannot disclose further medical information because it is the study sponsor, but added in its statement, "All trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards."
The AstraZeneca/Oxford partnership is one of the vaccine development efforts against the coronavirus that is furthest along. The company recently began a phase 3 trial in the United States that aims to enroll 30,000 volunteers.
In late July, results of a preliminary safety and effectiveness study found that more than two-thirds of the people who received the experimental vaccine reported fatigue and headache after inoculation. Muscle aches and fever were also common. But the researchers said then that there were no "serious adverse reactions" among the more than 500 people vaccinated and that most of the effects were "mild or moderate in severity."
In May, the Trump administration awarded the AstraZeneca effort up to $1.2 billion from the Biomedical Advanced Research and Development Authority as part of Operation Warp Speed, the administration's push to have a widely available coronavirus vaccine by January.
You can contact NPR science correspondent Joe Palca email@example.com.
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AstraZeneca inaanza majaribio ya chanjo ya COVID-19 nchini Uingereza, kampuni ya dawa ya AstraZeneca imesema Jumamosi kwamba majaribio ya chanjo ya COVID-19 yameanza tena nchini Uingereza, ingawa bado hayajaanza nchini Marekani. Majaribio ya chanjo ya COVID-19 yaliwekwa kando duniani kote mapema wiki hii baada ya mshiriki mmoja wa Uingereza katika moja ya masomo hayo kuugua ugonjwa wa neva. Chanjo hiyo ilitengenezwa na Chuo Kikuu cha Oxford pamoja na AstraZeneca. Lengo la utafiti huo ni kuona kama chanjo hiyo inaweza kuzuia COVID-19 na ikiwa ni salama. Ingawa uchunguzi wa awali haukufunua athari mbaya za chanjo hiyo, matatizo ya kawaida ya chanjo yoyote, ikiwa yapo, yanaweza kutoonekana hadi itakapowatolewa kwa maelfu au makumi ya maelfu ya watu. AstraZeneca imesema majaribio yote ya chanjo hiyo yamesimamishwa baada ya mshiriki mmoja wa UK kuonesha dalili za ugonjwa wa transverse myelitis, ugonjwa wa uti wa mgongo unaosababisha kupooza. "Kulingana na taarifa ya kampuni ya dawa hiyo, utafiti huo ulisimamishwa ""ili kuruhusu ukaguzi wa data za usalama na kamati huru na wasimamizi wa kimataifa.""" "Kulingana na taarifa hiyo, ""kamati hiyo imemaliza uchunguzi wake na kuelekeza Mamlaka ya Udhibiti wa Bidhaa za Afya ya Dawa, sawa na Idara ya Chakula na Dawa ya Uingereza, kwamba majaribio nchini Uingereza ni salama kuanza tena.""" "Katika barua pepe kwa NPR Jumamosi, msemaji wa AstraZeneca alisema, ""Kampuni itaendelea kufanya kazi na mamlaka za afya ulimwenguni kote, pamoja na FDA, na kuelekezwa wakati majaribio mengine ya kliniki yanaweza kuanza tena.""" AstraZeneca imesema haitaweza kutoa taarifa zaidi za matibabu kwa sababu ni mdhamini wa utafiti huo, lakini imeongeza katika taarifa yake, "Wachunguzi wote wa majaribio na washiriki watasasishwa na habari zinazohusiana, na hii itafunuliwa kwenye usajili wa kliniki ya kimataifa, kulingana na majaribio ya kliniki na viwango vya udhibiti." Ushirikiano wa AstraZeneca na Oxford ni moja ya juhudi za maendeleo ya chanjo dhidi ya coronavirus ambayo ni mbali zaidi. Kampuni hiyo imeanzisha majaribio ya awamu ya tatu nchini Marekani, ambayo yanalenga kuajiri wajitoleaji 30,000. Matokeo ya utafiti wa awali wa usalama na ufanisi yalionyesha kuwa zaidi ya thuluthi mbili ya watu waliopokea chanjo ya majaribio waliripoti uchovu na maumivu ya kichwa baada ya chanjo. Maumivu ya misuli na homa zilikuwa pia jambo la kawaida. "Lakini watafiti walisema wakati huo kwamba hakukuwa na ""madhara makubwa"" miongoni mwa watu zaidi ya 500 waliopigwa chanjo na kwamba athari nyingi zilikuwa ""ndogo au za kiwango cha kati.""" Serikali ya Trump ilitoa msaada wa dola bilioni 1.2 kwa AstraZeneca kutoka kwa Mamlaka ya Utafiti na Maendeleo ya Biomedical kama sehemu ya Operesheni ya Warp Speed, kampeni ya serikali ya kuwa na chanjo ya coronavirus inayopatikana kwa wingi ifikapo Januari. Unaweza kuwasiliana na mwandishi wa sayansi wa NPR Joe Palca kwa barua pepe @example.com. Copyright 2021 NPR Kwa maelezo zaidi, tembelea www.nl.org.