The United States may have four Covid-19 candidate vaccines in large-scale clinical trials by the middle of September, according to a report by the USA today. Health and Human Services Deputy Chief of Staff Paul Mango, who is also the agency’s liaison with Operation Warp Speed, said that the US government was very pleased with the progress. He added that the agency felt it was “absolutely on track”, if not a little ahead, in terms of their overall objective – which was tens of millions of (doses of) safe and effective vaccines approved for calendar year-end. Mango said that each Phase 3 clinical trial would enroll 30,000 volunteers and that the two underway currently were about halfway there.
Britain is preparing to revise its laws to allow the emergency use of any effective coronavirus vaccine before it is fully licensed — but only if the shots meet required safety and quality standards. In a statement Friday, Prime Minister Boris Johnson’s Conservative government said it was adopting “reinforced safeguards” to allow the country’s medicines regulatory agency to grant temporary authorization of a COVID-19 vaccine, provided it meets safety and quality standards.The proposed regulations would allow coronavirus vaccines to receive an emergency approval allowing people to be immunized while the full licensing process is being finished. Typically, vaccines are only used after the licensing review has been completed, a process which can take several months.
Here are a few updates on the coronavirus vaccine:
• WHO Sweetens Deal for Wealthier Nations | Wealthier countries that join the World Health Organization’s COVID-19 vaccine plan are being offered a new option to pick and choose which shots they get while reserving a right to receive their “full share” of doses, documents seen by Reuters show. The change appears aimed at convincing governments which have negotiated their own bilateral deals securing experimental vaccines to also sign up for the global COVAX facility by Monday’s deadline for submitting expressions of interest.
“They are trying to be more flexible for self-financing countries to make it more interesting… There are some advantages to incentivise you to pay upfront,” said a Western diplomat familiar with the terms. The United States, Japan, Britain and the European Union have struck their own deals to secure millions of COVID-19 vaccine doses for their citizens, ignoring the WHO’s warnings that “vaccine nationalism” will squeeze supplies.
• Sanofi More Confident About Its Coronavirus Vaccines | Sanofi’s confidence in its coronavirus vaccine candidates has increased this summer as the French drugmaker prepares to start clinical trials, its chief executive told Reuters. The company is working on two of the more than 150 potential vaccines being developed across the world to tackle the COVID-19 pandemic, which has claimed more than 831,000 lives and sparked economic chaos. One candidate, to be manufactured on the back of an existing platform that develops vaccines to treat flu, will use an adjuvant made by Britain’s GlaxoSmithKline (GSK) to boost its efficacy.
• Bangladesh’s Beximco Invests in Serum Institute of India | Bangladesh’s Beximco Pharmaceuticals is investing in the Serum Institute of India (SII) to ensure Dhaka gets priority access to COVID-19 vaccines being developed by the Indian drug manufacturer, the company said on Friday. The deal announced by the Bangladeshi generic drugmaker comes after Dhaka said this month it was ready to hold trials of candidate vaccines being developed by India as both countries seek to curb the spread of the virus.
• Putin Praises Russian Vaccine | The Russian president on Thursday praised a coronavirus vaccine that Russia approved for use earlier this month as effective and safe, a clear bid to address international skepticism about the shots that have only been studied for two months in a few dozen people. In an interview with the state Rossia 24 TV channel released Thursday, President Vladimir Putin insisted that the world’s first vaccine against coronavirus to receive a government go-ahead was approved “in strict accordance with Russian laws” that are in line with “international practice and regulations.”
• Novavax Firm May File for Vaccine Approval by December 2020 | Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday. The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.
Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
• Peru to Start Testing China’s Sinopharm Vaccine | Peru will start testing coronavirus vaccines from China’s Sinopharm and U.S. drugmaker Johnson & Johnson in September, researchers said, which should help the country gain faster access to inoculations once the vaccines are approved.
Sinopharm began this week to recruit up to 6,000 volunteers in Peru, which Reuters data indicates has the highest number of COVID-19 deaths in relation to its population size. A team of Chinese scientists is expected to arrive in the Andean nation next week to work with local researchers, said Germán Málaga, a doctor and lead vaccine investigator at Lima’s Cayetano Heredia University.”This is going to happen around Sept. 3, to begin vaccinations on Sept. 8,” he said. Sinopharm’s clinical trials in Peru are being done with Cayetano Heredia and the state-run Universidad Mayor de San Marcos.
• China Approves Use of Emergency Vaccine | Sinovac Biotech coronavirus vaccine candidate CoronaVac was approved in July for emergency use as part of a programme in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said. China National Biotec Group (CNBG), a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm), also said it had obtained emergency use approval for a coronavirus vaccine candidate in social media platform WeChat on Sunday. CNBG, which has two vaccine candidates in phase 3 clinical trials, did not say which of its vaccines had been cleared for emergency use.
• Donald Trump Vows to ‘Crush Pandemic’ With Vaccine by Year-end | In a war cry against the pandemic, US President Donald Trump on Thursday vowed to “crush” Covid-19 with a vaccine by the end of the year, as he accepted the Republican nomination for a second term as POTUS. The US President said that the country is roped in deft scientist to develop the vaccines for coronavirus under ‘Operation Warp Speed’.
“We are marshaling America’s scientific genius to produce a vaccine in record time. We will have a safe and effective vaccine this year and together we will crush the virus,” Trump said, adding that three coronavirus vaccines will be ready for production soon and could be made available this year.
• French Govt Expects Vaccine by End of 2020 or Early Next Year | New coronavirus vaccines could be available from the end of 2020 or the beginning of 2021, a presentation by French Health Minister Olivier Veran suggested on Thursday. French Prime Minister Jean Castex said on Thursday the government must move fast to head off a deadly new COVID-19 wave as the virus’s reproduction level has jumped, with infections surging in the Paris region and among young people.
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