Vaccine updates: Japan’s cabinet approves plan for free COVID-19 shots

TOKYO: Japan’s cabinet approved a plan on Tuesday to use public funds to provide novel coronavirus vaccines to the public for free. The plan also calls for the government to bear the cost of any health damage caused by a vaccine, according to a document posted on the health ministry’s website.

Prime Minister Yoshihide Suga has pledged to provide enough vaccines for the coronavirus for the public by mid-2021. Japan has struck deals for hundreds of millions of doses from companies including AstraZeneca Plc and Pfizer Inc. (AFP)

S. Korea begins preliminary review of AstraZeneca’s COVID-19 vaccine 

SEOUL: South Korea’s food and drug ministry said on Tuesday it had begun a preliminary review of a COVID-19 vaccine being developed by AstraZeneca PLC for potential fast-track approval. The Ministry of Food and Drug Safety said in a statement that it had formed a screening team to review the vaccine candidate, with an application for formal approval expected in 90 days under its rapid approval programme for COVID-19 treatments and vaccines. The team is reviewing the vaccine’s non-clinical test data, the ministry said.

The ministry added that it had given a green light to some 26 clinical trials for COVID-19 treatments and vaccines as of Monday, by entities such as pharmaceutical companies Celltrion Inc and Genexine Inc, with seven completed and 19 ongoing.

AstraZeneca, Oxford Uni buoyed by vaccine response

LONDON (AFP): British pharma giant AstraZeneca said trials of its coronavirus vaccine pioneered with Oxford University had shown “encouraging” responses among elderly, as well as younger participants. The potential vaccine, one of 10 around the world in the most advanced phase III of trials, showed “strong immune responses” in all adult groups during the previous stage, according to an update from Oxford.

An AstraZeneca spokesman said the initial results “further build the body of evidence for the safety and immunogenicity” of its experimental vaccine. “It is encouraging to see immunogenicity responses were similar between older and younger adults, the spokesman added. The positive news emerged in data on the safety and immune responses of participants in the phase II stage of the trial Oxford has submitted for peer review in a medical journal. They include results for UK volunteers aged 56-69 and over 70, with formal publication of the data expected “in the coming weeks”.

“Our ongoing trials will provide further data, but this marks a key milestone and reassures us that the vaccine is safe for use and induces strong immune responses in both parts of the immune system in all adult groups,” the university said. Oxford and AstraZeneca have been trialing their potential vaccine for months in various countries around the world. It was suspended worldwide on September 6 after a participant’s illness, but resumed shortly thereafter in Britain. (AFP)

Pfizer not yet ready to release COVID-19 vaccine data

Drugmaker Pfizer Inc said on Tuesday it was not yet ready to release data from the late-stage trial of the COVID-19 vaccine candidate it is developing with Germany’s BioNTech SE. Pfizer said in a presentation that the independent monitor which will determine whether or not the trial has been successful has not conducted any interim efficacy analyses yet.

Chief Executive Albert Bourla has previously said the company could release data on whether or not the vaccine works as early as this month. Pfizer hopes to be the first U.S. drugmaker to unveil successful data from a late-stage COVID-19 vaccine trial, ahead of rival Moderna Inc. Pfizer and BioNTech launched their 44,000 volunteer phase 3 study of their vaccine candidate in late July. The data monitoring board is scheduled to make its first assessment of the vaccine’s performance after 32 participants in the trial become infected with the novel coronavirus.

Healthcare investor Brad Loncar said it was difficult to draw a positive or negative conclusion from the fact that the trial has not yet had its first interim analysis. “I think this means that the overall infection rate is a lot lower than Pfizer initially estimated,” Loncar said. “So the trial is just running a little slower than they thought.” 

The company also said that if the trial is successful, it still expects to file for emergency authorization of the vaccine candidate from U.S. regulators shortly after it has enough safety data in late November. Sales of cancer drug Ibrance grew 6% to $1.36 billion, beating analyst estimates of $1.39 billion, despite increased competition from Eli Lilly’s Verzenio. (Reuters)

42,000 volunteers for Pfizer vaccine trial

Pfizer Inc. said it has enrolled more than 42,000 patients in its Covid-19 vaccine trial, and more importantly, almost 36,000 have received their second dose as of October 26, the company said in its earnings statement Tuesday. But there was no update on what everyone was waiting for: news on when Pfizer could get its first efficacy results from the trial. The company has previously said they could come as soon as this month, depending on how fast cases accrue in the trial.

In a presentation affiliated with the Pfizer earnings, Pfizer dropped a clue as to where its Covid-19 vaccine trial stood in terms of getting efficacy results. It said that the data-monitoring board of scientists overseeing the trial has not conducted any interim efficacy analysis to date. What that means is that there have been fewer than 32 cases of Covid-19 in the trial so far. The first of four efficacy analyses is scheduled to be conducted when the trial achieves 32 cases. (Bloomberg)

Novavax delays US trial start of vaccine to November

Novavax Inc on Tuesday delayed the timeline for beginning a late-stage U.S. trial of its experimental coronavirus vaccine by roughly one month. The company said it would begin the trial by the end of November. It previously expected to start this month.

Novavax said it also expects interim data from an ongoing late-stage UK trial of its coronavirus vaccine in the first quarter of next year. The company said it had expanded its enrollment target in the UK trial to 15,000 volunteers from 10,000. It expects this could help assess safety and effectiveness of the vaccine in a shorter time period. Novavax expects data from UK trial of coronavirus vaccine in first-quarter 2021

Also on Tuesday, Novavax Inc said it expects interim data from a late-stage UK trial of its coronavirus vaccine in the first quarter of next year. The company also said it would begin a US late-stage trial of its experimental coronavirus vaccine by the end of November, from its previous expectation of October. (Reuters)

WHO chief warns against ‘vaccine nationalism’

BERLIN: The head of the World Health Organization (WHO) on Sunday called for global solidarity in the rollout of any future coronavirus vaccine, as the number of cases soared across the world. In a video address at the opening of the three-day World Health Summit in Berlin, Tedros Adhanom Ghebreyesus said the only way to recover from the pandemic was together and by making sure poorer countries had fair access to a vaccine.

“It is natural that countries want to protect their own citizens first but if and when we have an effective vaccine, we must also use it effectively. And the best way to do that is to vaccinate some people in all countries rather than all people in some countries,” he said. “Let me be clear: vaccine nationalism will prolong the pandemic, not shorten it.” Scientists around the world are racing to develop a vaccine against COVID-19, which has killed over 1.1 million people. (AFP)