Coronavirus Government Global Briefing: November 24

By Chris Woods

Tuesday November 24, 2020

Welcome to Coronavirus Government Global Briefing, Mandarin Premium’s coverage of local and global COVID-19 policy news.

Vaccine candidate races for US, UK rollouts

The chief scientific adviser for the US government’s “Operation Warp Speed” COVID-19 vaccine development program, Dr. Moncef Slaoui, has told NBC’s Meet the Press that first inoculations could take place as soon as 24 hours after the Food and Drug Administration meets to consider an emergency use application for Pfizer and German partner BioNTech’s candidate on December 10.

As CBC explains, approval for the drug would kick off the largest inoculation campaign in US history, with Slaoui noting that states will receive quantities of the mRNA-based vaccine ‘BNT162b2’ relative to their population and then, independent of the federal government, decide who gets priority access. The US Centers for Disease Control and Prevention and an advisory panel will, however, design recommendations for initial access, likely healthcare workers, front-line personnel and at-risk groups such as the elderly and immunocompromised.

Curiously, Britain could give regulatory approval to the candidate as soon as this week, the Telegraph (via Reuters) reports. Citing government sources, the paper reports regulators are about to start a formal appraisal of the drug and that the National Health Service had been told to be ready to administer it by December 1.

The reports come after Pfizer and BioNTech announced last week that, after conducting final efficacy analysis in their ongoing Phase 3 study, ‘BNT162b2’ met all of the study’s primary efficacy endpoints:

  • Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group.
  • Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was more than 94%.
  • Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved: data demonstrate the vaccine was well tolerated across all populations, with more than 43,000 participants enrolled; no serious safety concerns were observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue, at 3.8%, and headache, at 2.0%.

Science explained at the time that while Pfizer and BioNTech’s claim in early November to have hit 90% efficacy had little accompanying data, the companies have released more concrete information “now that the study has reached enough COVID-19 cases to end”. Two days later, they submitted their EUA.

Moderna Inc is also expected to seek an EUA for its mRNA-based candidate later in December after announcing 94.5% efficacy in the first interim analysis of its Phase 3 study.

And just last night, AstraZeneca announced that its protein-based candidate with the University of Oxford achieved 70% protection, but researchers found it could be as high as 90% when a person is only given an initial half-dose before the second full dose:

“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” Chief Investigator of the Oxford Vaccine Trial Professor Andrew Pollard said. “Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”

While it may be less effective than either the Pfizer-BioNTech or Moderna mRNA-based drugs, the Sydney Morning Herald notes the results will be seen as a triumph because Oxford’s protein-based candidate is both cheaper to produce and only requires refrigeration, rather than extremely cold temperatures, for storage.

These traits are especially important for manufacturing and distribution in low- and middle-income countries; as NDTV explains, current deals for these countries show the Oxford candidate currently accounts for more than 40% of expected supplies.

For information on all candidates, see the Regulatory Affairs Professionals Society’s COVID-19 vaccine tracker.

Local and international growing pains

As Crikey covered earlier this month, Australia is already manufacturing protein-based candidates — namely from AstraZeneca (an agreement with which will see doses for 15 million people manufactured locally, plus doses for another 1.9 million people delivered) and the University of Queensland/CSL (doses for 25.5 million immunisations manufactured here) — but does not have onshore facilities to manufacture mRNA-based vaccines, which would have to be imported.

Australia has another two deals for deliveries from Novavax’s nanoparticle vaccine (doses for 20 million immunisations) and Pfizer/BioNTech’s mRNA-based drug (doses for 5 million immunisations).

The Australian government earlier this month released a COVID-19 vaccine policy, which covers immunisation policy, regulation and governance in Australia; the approach to COVID-19 vaccination; currently-purchased COVID-19 vaccines; the roll-out of the vaccination program; data and reporting; and communication strategy.

As health economist Luke Slawomirski also explained at Crikey, Australia’s COVID-19 roll-out will face challenges including but not limited to:

  • Immunisation sites falling under various jurisdictions and ranging from GP clinics, dedicated vaccination clinics, workplaces, in-reach teams to visit people’s homes and aged care facilities, Aboriginal and Torres Strait Islander Community Health clinics, pharmacies, and schools.
  • Storage, handing and logistics especially for products like Pfizer’s that must be kept in ultra-cold temperatures, are only be available in hospitals and regional centres; this means that people living in remote areas (a good proportion of the priority groups) will need to travel some distances to be immunised (most likely twice, given two doses of the vaccine will be needed).
  • Overcoming scepticism for vaccinations in general, and especially those seen to be rushed through: “This fear is unfounded — Australia’s Therapeutic Goods Administration is among the world’s best regulatory bodies – but it exists, perpetuated and amplified on social media. A lot therefore hinges on government communication, which needs to be extremely clear and persuasive.”
  • Australia’s digital health infrastructure, especially My Health Record, needing to facilitate identification, contact and encouragement for people requiring immediate immunisation (including for immunisations requiring two shots, which in turn face timing requirements), who will then need to be vigilantly monitored and followed up to assess effectiveness and spot any adverse effects as soon as they occur.
  • “The current system for reporting adverse events following immunisation is paper-based. This must be addressed immediately to enable electronic linkage with relevant data sets such as myHR.”

On the home front: first federal-state fight over plugging COVID-19’s socio-economic gaps

As The Mandarin reported yesterday, the Victorian government has announced a two-year Secure Work Pilot Scheme to provide up to five days of sick and carer’s pay for vulnerable workers in highly casualised industries.

The announcement comes after outbreaks in the state hotel quarantine scheme and private aged care system exposed vulnerabilities of low-income workers in high-risk environments, and the scheme will see casual and insecure workers — including aged care staff, cleaners, hospitality staff, security guards, and supermarket workers — be paid the national minimum wage when sick or required to care for someone else.

“When people have nothing to fall back on, they make a choice between the safety of their workmates and feeding their family,” Dan Andrews said in a statement. “The ultimate decision they make isn’t wrong – what’s wrong is they’re forced to make it at all,” he said in a statement.”

“This isn’t going to solve the problem of insecure work overnight but someone has to put their hand up and say we’re going to take this out of the too hard basket and do something about it – and that’s exactly what we’re doing.”

Today’s budget will provide $5 million for consultation on the design of the two-year pilot, but any future ongoing scheme will be subject to an industry levy.

Since the announcement, Attorney-General Christian Porter slammed the ultimate proposal as “a massive tax on Victorian businesses who would be forced to pay for both a 25% additional loading in wages to compensate for casuals not receiving sick leave and then having to pay for an industry levy to fund sick leave as well.”

Instead, Porter called for an unspecified-mechanism to”strengthen the ability of workers to choose to move from casual to permanent full or part-time employment if that is what they want to do”, a proposal he says the industrial relations working group process has discussed.

“It must surely be a better approach to let people have greater choice between casual and permanent employment than forcing businesses to pay a tax so that someone can be both a casual employee and get more wages as compensation for not getting sick leave — but then also tax the business to pay for getting sick leave as well.”

Qantas to require proof of immunisation for international flights

According to A Current Affair, Qantas CEO Alan Joyce has announced the airline will change its terms and conditions to require passengers demonstrate proof of vaccination against COVID-19 to board international flights.

Joyce, who does not delve into legislation governing whether private companies can require “immunisation passports”, also flagged the possibility of similar rules for domestic travel.

State wrap

  • South Australia yesterday recorded one new case, whom the ABC reports is a family member of a hotel quarantine worker.
  • According to confidential government operational updates leaked to The Australian, the NSW hotel quarantine scheme has seen 169 security guards sacked, at least four overseas arrivals absconding from facilities, and warnings from contractors that they are unable to reliably extend beyond 820 daily deployments.

For health department updates: Federal, NSW, Victoria, QueenslandACTSouth Australia, Tasmania, Northern Territory and Western Australia.

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