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"COVID-19 Lockdown Exit Analysis" 14th Apr 2021

Overnight News RoundUp

No evidence that patents slow access to vaccines

Gutting patent rights is a dangerous prospect. Drug intervention is highly risky. Fewer than 12% of new molecular entities that make it to clinical trial stage get to the marketplace. It depends on $100bn in annual private sector investment on top of billions in taxpayer money. So before governments take the risk of waiving patents they should evaluate whether intellectual property rights are standing in the way of vaccine manufacturing and distribution.They need to answer two questions first:

  • Is there evidence that a broad range of COVID-19 vaccine developers have been asked for, and unreasonably refused, licenses to their IP?
  • Are there more facilities that could manufacture a vaccine quickly if they just has the intellectual property to do so?

IP legal expert Andrei Iancu argues - The IP system is working; there's robust collaboration and cooperation within the industry, insufficient license granting by patent holders is not an impediment to speedy vaccine rollout and that 'it just takes time to scale up,' pointing to the complexity of the manufacturing process.

COVAX reaches over 100 economies, 42 days after its first international delivery

Pfizer to pursue bringing COVID-19 vaccine to India after the country relaxed its import regulations

Pfizer said on Tuesday it would work towards bringing its COVID-19 vaccine to India after the government eased import rules and after withdrawing its emergency use application in February.

'We noted the recent announcement with regard to the regulatory pathway for global vaccines,' a Pfizer spokesperson told Reuters. 'We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government's immunisation programme.'

VAX Live: Concert announced to help get 27m medical workers vaccinated

  • Anti-poverty organisation, Global Citizen, is announcing a musical event called VAX Live: The Concert to Reunite the World - with the goal of enlisting corporations and philanthropists to raise $22bn for global vaccinations. The concert, which airs on May 8, will showcase The Foo Fighters, Eddie Vedder, J Balvin with H.E.R. The acts will be recorded at the SoFi Stadium in Los Angeles.The concert will be hosted by Selena Gomez and headlined by Jennifer Lopez.
  • Hugh Evans, CEO of Global Citizen, explained the magnitude of the problem his organisation hopes to address:
  • 'There are 27 million healthcare workers globally who don't have access to vaccines. It is not ethical for me to have access to the vaccine before these heroic first responders and community health workers. So we need government to start urgently donating those doses.'
  • 'We can't get back to ending extreme poverty while 150 million more people have been pushed back into extreme poverty this year due to the pandemic,' Evans said. 'Everything else is academic until we can get the pandemic under control.'
  • Global Citizen also launched its Vax Because initiative - to encourage people to get vaccinated when they can. The programme will include advertising developed by The Ad Council, YouTube and others to spark conversations among those who are hesitant about being vaccinated.

Newborns of COVID-vaccinated mums may be protected from infection

No evidence that patents slow access to vaccines
No evidence that patents slow access to vaccines
Andrei Iancu is a partner at Irell & Manella, a law firm based in Los Angeles, and a senior adviser to the Renewing American Innovation Project at the Center for Strategic and International Studies. He writes: "Some of those advocating for patent waivers have their hearts in the right place: They want to end the pandemic. But the evidence that setting aside patent protection will do anything to boost access or expand supply just isn’t there. Removing intellectual property protections on medicines will only ensure that we have fewer of them in the future. This is not a risk worth taking, especially when the evidence suggests we don’t need to."
COVAX reaches over 100 economies, 42 days after first international delivery
COVAX reaches over 100 economies, 42 days after first international delivery
More than one hundred economies have received life-saving COVID-19 vaccines from COVAX. The milestone comes 42 days after the first COVAX doses were shipped and delivered internationally, to Ghana on February 24th. COVAX has now delivered more than 38 million doses across six continents, supplied by three manufacturers, AstraZeneca, Pfizer-BioNTech and the Serum Institute of India (SII). Of the over 100 economies reached, 61 are among the 92 lower-income economies receiving vaccines funded through the Gavi COVAX Advance Market Commitment. Despite reduced supply availability in March and April – the result of vaccine manufacturers scaling and optimising their production processes in the early phase of the rollout, as well as increased demand for COVID-19 vaccines in India – COVAX expects to deliver doses to all participating economies that have requested vaccines in the first half of the year.
Pfizer to pursue bringing COVID-19 vaccine to India after the country relaxed its import regulations
Pfizer to pursue bringing COVID-19 vaccine to India after import relaxation
Pfizer Inc said on Tuesday it would work towards bringing the COVID-19 vaccine it developed with Germany's BioNTech to India after the government eased import rules, after withdrawing its application in February. "We have noted the recent announcement with regard to the regulatory pathway for global vaccines," a Pfizer spokesperson told Reuters in an email. "We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation program."
VAX Live: Concert to help get 27m medical workers vaccinated
VAX Live: Concert to help get 27m medical workers vaccinated
Backed by an international concert hosted by Selena Gomez and headlined by Jennifer Lopez, Global Citizen is unveiling an ambitious campaign to help medical workers in the world’s poorest countries quickly receive COVID-19 vaccines. The anti-poverty organisation is announcing the musical event – VAX Live: The Concert to Reunite the World – with a goal of enlisting corporations and philanthropists to raise $22bn for global vaccinations. The concert, which airs on May 8 on US TV channels ABC, CBS and FOX as well as on iHeartMedia radio stations and YouTube, will also showcase the Foo Fighters, Eddie Vedder, J Balvin and H.E.R. The acts will be recorded at SoFi Stadium in the western US city, Los Angeles, California. Ahead of the event, Hugh Evans, CEO of Global Citizen, highlighted the magnitude of the problem his organisation aims to address. “There are 27 million healthcare workers globally who don’t have access to the vaccine,” Evans told The Associated Press. “I’m 38 years old, and it’s not ethical for me to have access to the vaccine before these heroic first responders and community health workers. So we need governments to start urgently donating those doses.”
Newborns of COVID-vaccinated moms may be protected from infection
Newborns of COVID-vaccinated moms may be protected from infection
Two new Israeli studies find that COVID-19 antibodies pass robustly from mothers to their infants in breast milk for 6 weeks after vaccination and that no infants breastfed by their coronavirus-positive mothers had evidence of infection. The first study, led by researchers from Shamir Medical Center in Zerifin, Israel, and published as a research letter yesterday in JAMA, involved 504 breast milk samples from a convenience sample of 84 healthcare workers who chose to be vaccinated against COVID-19 because of their occupational risk for COVID-19 infection. All participants received two doses of the Pfizer/BioNTech coronavirus vaccine 21 days apart and were recruited through ads and social media from throughout Israel from Dec 23, 2020, to Jan 15, 2021. The women provided breast milk samples before they received the vaccine and then once a week for 6 weeks starting 2 weeks after the first dose, and completed weekly questionnaires.
Amid COVID surge, India fast-tracks approval for foreign vaccines
Amid COVID surge, India fast-tracks approval for foreign vaccines
India will fast-track emergency approvals for COVID-19 vaccines that have been authorised by Western countries and Japan, paving the way for possible imports of Pfizer-BioNTech, Johnson & Johnson, Novavax and Moderna shots. The move, which will drop the need for companies to do small, local safety trials for their vaccines before seeking emergency approval, came following the world’s biggest surge in cases in the country this month.
India reels amid virus surge, affecting world vaccine supply
India reels amid virus surge, affecting world vaccine supply
The Indian city of Pune is running out of ventilators as gasping coronavirus patients crowd its hospitals. Social media is full of people searching for beds, while relatives throng pharmacies looking for antiviral medicines that hospitals ran out of long ago. The surge, which can be seen across India, is particularly alarming because the country is a major vaccine producer and a critical supplier to the U.N.-backed COVAX initiative. That program aims to bring shots to some of the world’s poorest countries. Already the rise in cases has forced India to focus on satisfying its domestic demand — and delay deliveries to COVAX and elsewhere, including the United Kingdom and Canada.
US recommends ‘pause’ for J&J vaccine over clot reports
US recommends ‘pause’ for J&J vaccine over clot reports
The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots in six women between the ages of 18 and 48. One person died. The acting FDA commissioner expected the pause to last only a matter of days. But the decision triggered swift action in Europe and elsewhere as the drugmaker and regulators moved to halt the use of the J&J vaccine, at least for now. Hundreds of thousands of doses were due to arrive in European countries, where vaccinations have been plagued by supply shortages, logistical problems and concerns over blood clots in a small number of people who received the AstraZeneca vaccine, which is not yet cleared for use in the U.S.
US halts J&J COVID vaccine after reports of blood clots
The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) this morning said the United States should pause the administration of the Johnson & Johnson COVID-19 vaccine immediately, while the agencies examine how and if the vaccine was linked to six cases of a rare type of blood clots in women 18 to 49, including one death. "Right now I'd like to stress these events seem to be extremely rare," said Janet Woodcock, MD, acting FDA commissioner. Approximately 7 million doses of the Johnson & Johnson, or J&J, vaccine have been administered in the United States. Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said people who recently got the J&J vaccine should not panic, but should look for the following symptoms: persistent headache, abdominal pain, leg pain, and shortness of breath. The case-patients experienced their clots 6 to 13 days following injection, with a median of 9 days.
Feds call halt to Johnson & Johnson COVID-19 vaccine rollout after 'extremely rare' blood clot cases
After drug regulators on both sides of the Atlantic revealed safety probes into Johnson & Johnson’s COVID-19 vaccine, U.S. officials are calling for an immediate pause to the rollout. Since the vaccine’s late February emergency use authorization in the U.S., nearly 7 million people have received the shot. Six recipients of the vaccine—all women between 18 and 48—were diagnosed with rare blood clots afterward, the FDA says. One died and one is in critical condition. The FDA on Tuesday said it’s “recommending a pause in the use of this vaccine out of an abundance of caution.”
U.S. urges pause on use of Johnson & Johnson Covid-19 vaccine after rare blood clotting cases
Federal authorities on Tuesday recommended that states stop using Johnson & Johnson’s Covid-19 vaccine while an investigation is conducted into six serious cases of clotting problems — one of which was fatal — that were reported among women who received the vaccine. The blood clots are similar to those reported by several European countries after use of AstraZeneca’s Covid-19 vaccine. And they are similar to an event that occurred during Johnson & Johnson’s U.S.-based clinical trial, an event that led to a temporary pause in that trial last fall. That case involved a man in his 20s, STAT reported at the time.
J&J Delays European Rollout of Covid-19 Vaccine After Rare Clots
The pause in the rollout of Johnson & Johnson’s Covid-19 vaccine marks another setback for the world’s inoculation campaign, just as it was picking up speed in Europe and other regions where immunizations have lagged. The drugmaker suspended shots in Europe after U.S. officials paused vaccinations to review the cases of six women who suffered a type of brain blood clot similar to one reported as a rare side effect of the AstraZeneca Plc vaccine. Australia had already said it wouldn’t buy the J&J vaccine.
UK trial on switching COVID-19 vaccines adds Moderna and Novavax shots
UK trial on switching COVID-19 vaccines adds Moderna and Novavax shots
A UK study into using different COVID-19 vaccines in two-dose inoculations is being expanded to include shots made by Moderna and Novavax, researchers said on Wednesday. The trial, known as the Com-Cov study, was first launched in February to look at whether giving a first dose of one type of COVID-19 shot, and a second dose of another, elicits an immune response that is as good as using two doses of the same vaccine. The idea, said Matthew Snape, the Oxford University professor leading the trial, “is to explore whether the multiple COVID-19 vaccines that are available can be used more flexibly”.
Scientists test the risks and rewards of mixing Covid shots
Oxford scientists are expanding efforts to test whether two different Covid-19 vaccines can be combined, after some European countries worried by rare side effects with the Oxford/AstraZeneca jab started offering other vaccines as second shots. For the second stage of its continuing trial, the Oxford Vaccine Group is recruiting more than a thousand participants who have already received an AstraZeneca or BioNTech/Pfizer shot. The group of over-50s will either receive a second dose of the same vaccine or get a dose of the Moderna or Novavax shots. Matthew Snape, associate professor in paediatrics and vaccinology at Oxford, said the study could mean that people do not become “hostage to fortune” when there are supply shortfalls or changes to recommendations on who should take which vaccine.
Why would a Covid vaccine cause rare blood clots? Researchers have found clues
Why would a Covid vaccine cause rare blood clots? Researchers have found clues
A week after receiving the AstraZeneca Covid-19 vaccine, a 37-year-old woman in Norway went to the emergency department with fever and persistent headaches. A CAT scan of her head showed a blood clot in blood vessels involved in draining the brain, but her levels of platelets, involved in clotting, were low. She was treated with platelet infusions and a blood thinner, but had a bleed in her brain the next day. She underwent surgery to relieve the pressure on her brain but died two days later. This is the side effect, known as cerebral venous sinus thrombosis, that has caused a week of worries around the Covid-19 vaccine developed by AstraZeneca. On Tuesday, the U.S. government said that it had seen the same effect six times among the 6.8 million people given a dose of a similar vaccine, from Johnson & Johnson, and that it recommended a pause on use of that vaccine “out of an abundance of caution,” while researchers investigated.
WHO urges halt to sale of live wild animals in food markets
WHO urges halt to sale of live wild animals in food markets
The World Health Organization (WHO) is calling for a halt to the sale of live wild mammals in food markets to prevent the emergence of new diseases. The WHO said on Tuesday that while traditional markets play a central role in providing food and livelihoods for large populations, banning the sale of live wild mammals could protect the health of market workers and shoppers alike. It said some of the earliest known cases of COVID-19 were linked to a wholesale traditional food market in Wuhan in China, with many of the initial patients stall owners, market employees or regular visitors to the market. The coronavirus’s origins more than a year ago have been the source of intense speculation, much of it centred around the likelihood that it was carried by bats and passed to humans through an intermediary species sold as food or medicine in traditional Chinese wet markets. The interim guidance was drawn up alongside the World Organisation for Animal Health (OIE) and the United Nations Environment Programme (UNEP).
Vaccine made for South African Covid variant promising, says Moderna
Vaccine made for South African Covid variant promising, says Moderna
An experimental vaccine targeted at the South African strain of Covid-19 has produced antibodies in laboratory mice, its maker said last night, offering an early sign that it could protect humans against the variant. Moderna is developing a vaccine to target the B.1.351 variant, which was discovered in South Africa, as well as a multivalent vaccine that combines its original vaccination with the South Africa-specific jab. The company is the first to produce a vaccine designed for the variant detected in South Africa and said its pre-clinical trials in mice for both jabs “improved neutralising titers”, meaning that antibodies detected in the blood increased. The multivalent vaccine would provide the broadest level of immunity, according to Moderna.
Coronavirus Variants Don’t Have to Be Scary. Still, Mask Up.
Opinion | Coronavirus Variants Don’t Need to Be Scary
Five variants have now been proved guilty, as shown by the Centers for Disease Control and Prevention’s designation “variants of concern.” They are B.1.1.7 (first identified in Britain), B.1.351 (first found in South Africa), P.1 (identified in Brazil) and two more recent variants found in California and New York. Each has fewer than two dozen notable mutations, many of which are in the virus’s spike protein, which binds to our cells and is the vaccines’ principal target. Some mutations enhance the virus’s ability to bind to the cells lining our upper airway, while others interfere with our bodies’ capacity to mount a full immune response.
Stalled Pfizer deal clouds Israel's hopes of swift herd immunity
Stalled Pfizer deal clouds Israel's hopes of swift herd immunity
A bid to secure more Pfizer/BioNTech doses for Israel’s world-beating vaccination drive has become mired in political squabbles, just as its leaders saw the coveted prize of “herd immunity” as within reach. Although more than half the population has been inoculated, Israel may not be able to keep up the momentum of the roll out. Paralysed by repeated elections and political infighting, Prime Minister Benjamin Netanyahu’s caretaker government has been unable to push through a deal for additional doses.
Vaccine passport discussions should prioritize fairness over economics, ethicist says
Vaccine passport discussions should prioritize fairness over economics, ethicist says
The issue of vaccine passports is one rife with the potential for discrimination, and should be approached with a focus on fairness above the economic benefits, says one bioethicist. “(Passports) have the potential to make the inequities that we're seeing from COVID even worse because we know that people who are the hardest hit by COVID are actually the least likely to be vaccinated in some cases at this point in time,” University of Toronto researcher Alison Thompson told CTV’s Your Morning on Monday. “We want to make really sure that vaccine access has been equitable and that it's been not just accessible, but that we have actually reached those communities that need it the most.”
Covid-19: Vaccines alone will not stop Covid spreading - here's why
Covid-19: Vaccines alone will not stop Covid spreading - here's why
Many of us are hoping vaccines against coronavirus will be our route out of lockdown, enabling us to reclaim our old lives. But scientists say jabs alone will not currently be enough and other measures are still needed. Scroll down to find out why.,,,,
COVID-19 vaccines have prevented more than 10,000 deaths in England, PHE says
AstraZeneca: Irish health body recommends vaccine restriction
The Oxford-AstraZeneca vaccine should be limited to over-60s, the Republic of Ireland's National Immunisation Advisory Committee (NIAC) has said. The body oversees the Covid-19 vaccine rollout programme in the Republic. It said that the vaccine's benefits may vary by age and that, as other vaccines are available, it has revised its vaccine recommendations, reports RTÉ. All AstraZeneca vaccination clinics planned for Tuesday should now be cancelled, it has also been advised.
AstraZeneca - more limitations on vaccine usage
COVID-19 vaccines have prevented more than 10,000 deaths in England, PHE says
The COVID-19 vaccination programme has prevented 10,400 deaths among those aged over 60 years in England as of March 2021, Public Health England (PHE) has said. In a statement published on 8 April 2021, PHE said that the figure was calculated by comparing the observed number of deaths between 8 December 2020 and the end of March 2021 with the number of deaths expected if there had been no vaccination programme. It estimated that 9,100 deaths were prevented in people aged 80 years and over; 1,200 in those aged 70–79 years; and 100 in those aged 60–69 years. PHE added that there was “increasing evidence that vaccines help to reduce transmission”, meaning that the true number of prevented deaths is likely to be higher.
'Confusing' Israeli COVID-19 reinfection study says people might still be vulnerable after vaccination
An Israeli study says a COVID-19 variant can still infect vaccinated people — here's what Fauci says the research means
A small Israeli study indicates that some of the new coronavirus variants may put people who have been vaccinated at higher risk of breakthrough infections, though U.S. health officials questioned some of the wording used in the preliminary research. These types of cases are called “breakthrough infections,” which occur when someone who has completed their COVID-19 vaccination later gets sick from the virus. The preprint, which was published Friday and has not been peer reviewed, gained attention over the weekend after it said that the B.1.351 variant was more likely to infect people in Israel who had been vaccinated with Pfizer Inc.’s PFE, +0.51% COVID-19 vaccine, compared with other strains of the virus.
Corticosteroid shortens recovery time in COVID-19 patients treated in the community, early trial results show
Corticosteroid shortens recovery time in COVID-19 patients treated in the community, early trial results show
Budesonide has been found to shorten recovery time in COVID-19 patients aged over 50 years who are being treated in the community, according to interim findings from the Platform Randomised Trial of Interventions Against COVID-19 in Older People (PRINCIPLE). According to the findings, early treatment with the inhaled corticosteroid shortened recovery time by a median of three days in patients with COVID-19 who were at higher risk of more severe illness, and were being treated at home and in other community settings. Inhaled budesonide was added to the PRINCIPLE trial on 28 November 2020, but recruitment stopped on 31 March 2021 after the trial steering committee decided that enough patients had been enrolled to be able to establish if the drug had a meaningful benefit on time to recovery.
COVID-19: 'Biggest surge testing operation to date' under way as dozens of South African variant cases found in south London
COVID-19: 'Biggest surge testing operation to date' under way as dozens of South African variant cases found in south London
The largest surge testing operation so far is taking place in areas of south London after more than 70 confirmed or probable cases of the South African variant of COVID-19 were detected. The government says dozens of people are isolating or have completed their isolation after contracting the variant, B.1.351, and the cluster of infections is believed to be "significant".
COVID-19: More than 1.3 million people in England haven't yet taken up coronavirus vaccine offer, analysis suggests
COVID-19: More than 1.3 million people in England haven't yet taken up coronavirus vaccine offer, analysis suggests
More than a million people have not yet taken up the offer of a COVID vaccine in England, analysis shows. It comes after the government said it had reached its goal of offering a coronavirus vaccine to everyone most vulnerable to the disease ahead of the 15 April target. NHS England says 19 out of 20 of those most at risk have had a COVID jab.
Ramadan 2021: Muslims can get Covid-19 jab without breaking fast, Manchester’s public health chief confirms
Ramadan 2021: Muslims can get Covid-19 jab without breaking fast, Manchester’s public health chief confirms
Muslims are being advised that they can take the Covid-19 vaccine during Ramadan without breaking fast. Taking a coronavirus test, either PCR (polymerase chain reaction) or lateral flow test (LFT), is also safe during this time, Manchester’s public health chief has added. The month of Ramadan is marked by acts of devotion, including completely abstaining from eating or drinking between dawn and sunset. Islamic scholars, working in partnership with the Muslim Council of Britain, have shared messages of reassurance to worshipers confirming that getting the Covid-19 vaccine during Ramadan is permitted.
Gilead nixes Veklury COVID-19 trial as vaccines roll out, more convenient drugs emerge for outpatients
Gilead nixes Veklury COVID-19 trial as vaccines roll out, more convenient drugs emerge for outpatients
Gilead Sciences has been exploring its antiviral remdesivir for COVID-19 in the outpatient setting, hoping to replicate the success seen in hospitalized patients. But as new treatments emerge, the company now thinks the drug, in its current form, simply doesn’t have a role to play outside hospitals. Gilead has decided to stop a phase 3 trial of remdesivir as an intravenous infusion in high-risk nonhospitalized patients with COVID-19, the company said Monday. The decision wasn’t about efficacy or safety but the “evolution of the COVID-19 landscape,” it said. In other words, Gilead no longer believes there’s a market for IV remdesivir, or Veklury, that requires administration in a healthcare facility for nonhospitalized patients. As vaccine rollouts ramp up, the overall need for COVID-19 treatments will further decline. The shrinking patient pool has likely also made it hard for Gilead to enroll patients in the new study. Veklury, in its current FDA-approved use for hospitalized patients, brought in sales of $1.94 billion in the fourth quarter of 2020 alone. But for 2021, Gilead’s projecting a total haul between $2 billion and $3 billion, depending on how the pandemic evolves.
France suspends all Brazil flights due to virus variants
France suspends all Brazil flights due to virus variants
France suspended all flights from Brazil on Tuesday amid mounting fears over the particularly contagious coronavirus variant that has been sweeping the South American country. Prime Minister Jean Castex announced the suspension to parliament. “We note that the situation is getting worse and so we have decided to suspend all flights between Brazil and France until further notice,” Castex said, drawing scattered applause from lawmakers. Although France has seen comparatively few known cases of the P.1 variant striking Brazil, the ravages it is causing in Latin America’s largest nation are increasingly raising alarm bells in France

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