Ọgwụ Novavax' COVID-19 nyere nkwado nwa oge na New Zealand

Novavax, Inc. (Nasdaq: NVAX), ụlọ ọrụ biotechnology raara onwe ya nye na-emepụta na ịzụ ahịa ọgwụ mgbochi ọgbọ na-abịa maka ọrịa na-efe efe, taa mara ọkwa na New Zealand's Medsafe enyela nkwado nwa oge nke NVX-CoV2373, ọgwụ mgbochi Novavax' COVID-19 (adjuvanted). ), maka ịgba ọgwụ mgbochi ọrịa iji gbochie ọrịa coronavirus 2019 (COVID-19) nke SARS-CoV-2 kpatara n'ime ndị mmadụ dị afọ 18 gbagoro. A ga-ebunye ọgwụ mgbochi a na New Zealand n'okpuru akara aha Nuvaxovid™.

"Nkwenye nwa oge nke Nuvaxovid site na Medsafe ga-enyere Novavax aka ibuga ọgwụ mgbochi COVID-19 nke mbụ sitere na protein na New Zealand," Stanley C. Erck, Onye isi ala na onye isi nchịkwa, Novavax kwuru. "Anyị na-ekele Medsafe maka nyocha ya nke ọma yana, ka ọrịa na-efe efe na-aga n'ihu, anyị na-agba mbọ ịkwado New Zealand na ụwa n'ọgụ megide COVID-19."

Nkwenye nke Medsafe nwa oge dabere na nlebanya ogo, nchekwa na data arụmọrụ ewepụtara maka nyocha. Nke a na-agụnye ule ụlọ ọgwụ abụọ dị mkpa na-adọ 3: PREVENT-19 debanyere aha ihe dị ka ndị sonyere 30,000 na US na Mexico, nke e bipụtara nsonaazụ ya na New England Journal of Medicine (NEJM); na ikpe nwere ihe fọrọ nke nta ka ọ bụrụ ndị sonyere 15,000 na UK, nke e bipụtara nsonaazụ ya na NEJM. N'ime ule abụọ a, NVX-CoV2373 gosipụtara nrụpụta ọrụ yana nchekwa na-emesi obi ike na profaịlụ nnabata. Ihe omume ọjọọ dị njọ na nke siri ike dị ntakịrị na ọnụọgụ n'etiti ọgwụ mgbochi na otu placebo. Mmeghachi omume ọjọọ ndị a na-ahụkarị n'oge ọmụmụ ụlọ ọgwụ (ụdị ugboro ugboro nke ≥1/10) bụ isi ọwụwa, ọgbụgbọ ma ọ bụ vomiting, myalgia, arthralgia, ebe ịgba ọgwụ nro / mgbu, ike ọgwụgwụ na adịghị ike. Novavax ga-aga n'ihu na-anakọta na nyochaa data ụwa n'ezie, gụnyere nlekota nke nchekwa na nyocha nke ụdị dị iche iche, dịka a na-ekesa ọgwụ mgbochi.

Novavax na Gọọmenti New Zealand kwuburu ọkwa nkwekọrịta ịzụrụ ụzọ (APA) maka nde 10.7 nke ọgwụ mgbochi Novavax'Covid-19. Nkwenye nwa oge a na-akwado mmekorita nrụpụta Novavax na Serum Institute of India (SII), onye na-emepụta ọgwụ mgbochi kachasị n'ụwa site na olu, nke ga-ebunye New Zealand doses mbụ. A ga-emesịa gbakwunye data sitere na saịtị nrụpụta ndị ọzọ na yinye ọkọnọ zuru ụwa ọnụ nke Novavax.

Novavax nwetara ikike ịre ahịa ọnọdụ maka NVX-CoV2373 na European Union, ndepụta iji ihe mberede (EUL) sitere na Healthtù Ahụ Ike (wa (WHO) ma nye ya ndebanye aha nwa oge site na nchịkwa ngwa ahịa ọgwụgwọ na Australia, n'etiti ndị ọzọ. A na-enyochakwa ọgwụ mgbochi ugbu a site n'aka ọtụtụ ụlọ ọrụ na-ahụ maka nchịkwa gburugburu ụwa, gụnyere US Food and Drug Administration (FDA).

Maka ozi ndị ọzọ na Nuvaxovid, gụnyere akwụkwọ data New Zealand akwadoro yana ozi ọgwụ ndị ahịa akwadoro na ozi nchekwa dị mkpa, ma ọ bụ ịrịọ ozi ndị ọzọ, biko gaa na webụsaịtị ndị a:

• Webụsaịtị ikike Novavax zuru ụwa ọnụ
• Ọnọdụ ngwa ọgwụ COVID-19
• Ozi maka ndị na-ede akwụkwọ / ndị ahịa na-achọ  

Aha aha Nuvaxovid™ ka FDA enyebeghị ikike maka ojiji na US. Onye nkwado Novavax na Australia na New Zealand bụ Biocelect Pty. Ltd. 

Nkwado nke Nuvaxovid nwa oge^™ na New Zealand

Medsafe enyela nkwado nwa oge nke Nuvaxovid™ COVID-19 Vaccine (adjuvanted) maka ọgwụ mgbochi arụ ọrụ iji gbochie COVID-19 nke SARS-CoV-2 kpatara n'ime ndị mmadụ gbara afọ 18 gbagowe. 

Ozi Nchedo Dị Mkpa

• A machibidoro Nuvaxovid n'ime ndị mmadụ nwere hypersensitivity na ihe na-arụ ọrụ, ma ọ bụ ihe ọ bụla nke excipient.
• A kọwo ihe omume anaphylaxis site na nchịkwa ọgwụ COVID-19. Ọgwụgwọ na nlekọta ahụike kwesịrị ekwesị kwesịrị ịdị ma ọ bụrụ na mmeghachi omume anaphylactic na-esochi nchịkwa ọgwụ mgbochi. E kwesịghị inye ndị nwere anaphylaxis dose nke abụọ nke ọgwụ mgbochi na ọgwụ mbụ nke Nuvaxovid.
• Mmeghachi omume metụtara nchegbu, gụnyere mmeghachi omume vasovagal (syncope), hyperventilation, ma ọ bụ mmeghachi omume metụtara nchekasị nwere ike ime na njikọta na ịgba ọgwụ mgbochi ọrịa dị ka nzaghachi psychogenic na injection agịga. Ọ dị mkpa na a na-akpachapụ anya iji zere mmerụ ahụ site na ịda mbà.
• Ekwesịrị yigharịrị ịgba ọgwụ mgbochi ọrịa n'ime ndị mmadụ nwere nnukwu ọrịa febrile siri ike ma ọ bụ nnukwu ọrịa.
• Ekwesịrị iji nlezianya na-enye Nuvaxovid n'ime ndị mmadụ na-anata ọgwụgwọ anticoagulant ma ọ bụ ndị nwere thrombocytopenia ma ọ bụ ọrịa coagulation ọ bụla (dị ka haemophilia) n'ihi na ọbara ọgbụgba ma ọ bụ ọnya nwere ike ime na-esochi nchịkwa intramuscular na ndị a.
• Ịdị irè nke Nuvaxovid nwere ike dị ala n'ime ndị mmadụ na-egbochi ọgwụ mgbochi.
• Ekwesịrị ịtụle nchịkwa Nuvaxovid n'ime afọ ime naanị mgbe uru ndị nwere ike ịkarị karịa ihe egwu ọ bụla nwere ike ime maka nne na nwa ebu n'afọ.
• Mmetụta dị na Nuvaxovid nwere ike imetụta ikike ịnya ụgbọ ala ma ọ bụ iji igwe nwa oge.
• Ndị mmadụ n'otu n'otu nwere ike agaghị echebe nke ọma ruo ụbọchị 7 ka ha gachara ọgwụ nke abụọ. Dịka ọ dị na ọgwụ mgbochi niile, ịgba ọgwụ mgbochi na Nuvaxovid nwere ike ọ gaghị echebe ndị niile na-anata ọgwụ mgbochi.
• Mmeghachi omume ọjọọ ndị a na-ahụkarị n'oge ọmụmụ ụlọ ọgwụ (ụdị ugboro ugboro nke ≥1/10) bụ isi ọwụwa, ọgbụgbọ ma ọ bụ vomiting, myalgia, arthralgia, ebe ịgba ọgwụ nro / mgbu, ike ọgwụgwụ na adịghị ike.