Thailand develops robotic system to squeeze out more vaccine doses

BANGKOK— As Thailand struggles with its worst coronavirus outbreak yet, researchers in the country have developed a machine to draw out COVID-19 vaccine doses more efficiently and optimize lower-than-expected supplies.

Using a robotic arm, the "AutoVacc" system can draw 12 doses of the AstraZeneca vaccine in 4 minutes from a vial, according to researchers at Chulalongkorn University, who made the machine that has been used at the university's vaccination center since Monday.

That is up 20 percent from the standard 10 doses drawn manually, they said. The machine only works on AstraZeneca multi-dose vials currently and labels show each vial can provide 10 to 11 doses.

"The machine guarantees with accuracy that we can gain an extra 20 percent from each vaccine vial- from 10 to 12 doses," said Juthamas Ratanavaraporn, the lead researcher of the team at the university's Biomedical Engineering Research Center.

"The extra 20 percent that we get means that if we have AstraZeneca for 1 million people, this machine can increase the number of doses to 1.2 million people," said Juthamas.

While some health workers using low dead space syringes (LDSS) that aim to reduce wastage can draw up to 12 doses per vial, it requires manpower and a high level of skill, she said.

"This could drain a lot of the health workers' energy. They would have to do this every day for many months," Juthamas said.

Thailand had kept COVID-19 largely under control for much of the pandemic, but more virulent variants like Delta have sent cases and deaths soaring since April, ramping up pressure on authorities to increase the pace of vaccinations.

So far, around 9 percent of Thailand's population of more than 66 million have been fully vaccinated, with the rollout hindered by lower-than-anticipated vaccine supplies.

The research team say they should be able to produce 20 more AutoVacc units within 3 or 4 months, but that government funds and support would be needed to expand across the country.

The prototype machine costs 2.5 million baht ($76,243), including other materials like syringes, said Juthamas, adding that while they were open to export opportunities, that was something for the future.

They also plan to make similar machines to use with the Pfizer-BioNTech and Moderna vaccines, she added.

Juthamas said the machine was aimed at removing burdens on health workers. Thailand has reported around 1.1 million COVID-19 infections and 10,085 deaths in total, pushing parts of the health system to the brink.

"When the health workers are too tired, there are also chances of human error, so we should let the machines work on this," she said.

-reuters-

S.Korea says AstraZeneca, Pfizer COVID-19 vaccines 87% effective after first shot

SEOUL - One dose of COVID-19 vaccines from AstraZeneca Plc and Pfizer was 86.6 percent effective in preventing infections among people aged 60 and older, real world data released by South Korea showed on Wednesday.

Data by the Korea Disease Control and Prevention Agency (KDCA) showed the Pfizer vaccine, jointly developed by BioNTech, was 89.7 percent effective in preventing infection at least two weeks after a first dose was given, while the AstraZeneca shot was 86.0 percent effective.

Its analysis is based on more than 3.5 million people in South Korea aged 60 and older for two months from Feb. 26 and included 521,133 people who received a first dose of either Pfizer or AstraZeneca shot.

There were 1,237 COVID-19 cases in the data and only 29 were from the vaccinated group, the KDCA said.

"It is shown that both vaccines provide a high protection against the disease after the first dose. (People) should get full vaccinations according to recommended schedule, as the protection rate will go up further after a second dose," it said.

The findings come as South Korea seeks to drum up participation in its immunization drive after reports about potential safety issues discouraged some people from getting vaccinated.

"Around 95 percent of people who died from the coronavirus in our country were senior citizens aged 60 or older, and the vaccines will sharply lower risks for those people," health ministry official Yoon Tae-ho told a briefing on Wednesday.

Yoon said the possibility of side effects including blood clotting are "extremely low" and they are mostly curable.

South Korea has so far vaccinated 6.7 percent of its 52 million strong population, but has set an ambitious target of giving shots to 70 percent of its people by September and reaching herd immunity by November.

Starting on Wednesday, South Koreans who are fully vaccinated and show a negative COVID-19 test and no symptoms will be exempted from the two-week mandatory quarantine upon their return from overseas travel, to encourage more vaccinations.

The KDCA reported 676 new COVID-19 cases as of midnight on Tuesday, bringing the country's total infections to 124,945, with 1,847 deaths.

-reuters-

European Union regulator: AstraZeneca vaccine 'safe, effective'

Europe's medical regulator said Thursday the AstraZeneca vaccine is "safe and effective" and not associated with a higher blood clot risk, after more than a dozen countries paused rollouts over health fears. 

The closely watched announcement comes after the WHO and Britain's health watchdog both said the vaccine was safe, adding that it was far riskier to not get the shot as several countries face a worrying rise in coronavirus cases. 

"The committee has come to a clear scientific conclusion: this is a safe and effective vaccine," European Medicines Agency (EMA) chief Emer Cooke said Thursday after a probe by the body's safety committee. 

"The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots," she added.

However, the agency "cannot rule out definitively" a link to a rare clotting disorder. 

The UK health regulator on Thursday also said there were no links between blood clots and the AstraZeneca jab, or the Pfizer vaccine. 

"There is no evidence that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine," said June Raine, chief executive of the independent Medicines and Healthcare products Regulatory Agency (MHRA). 

And the World Health Organization (WHO) said again Thursday it was better to take the AstraZeneca vaccine than not, after saying it was looking into available data on the shot.

- 'Situation critical' -

The furore around the jab has marred the global vaccine drive aimed at ending a pandemic that has killed more than 2.6 million people, and comes as several countries report jumps in new cases.

France recorded its highest daily caseload in nearly four months Wednesday, with the authorities set to announce on Thursday new measures.

"Let's be clear, we're in a third wave mostly down to the rise of this famous British variant," French President Emmanuel Macron said, referring to the more-contagious variant first detected in the UK. 

"The situation is critical. It's going to be very hard until mid-April."

Bulgaria and Ukraine readied for tougher restrictions to stem rising cases, while the WHO issued a grim update on rising infections in Central Europe and the Balkans.

- 'Italy's Wuhan' -

So far, more than 399 million coronavirus vaccine doses have been administered globally, mostly in wealthier nations that have secured contracts with drug makers. 

AstraZeneca's shot, among the cheapest available and easier to store and transport than some of its rivals, has been billed as the vaccine of choice for poorer nations.

It is currently a vital part of Covax, which was set up to procure Covid-19 vaccines and ensure their equitable distribution around the world.

Countries ranging from France to Venezuela and Indonesia paused the rollout of the jab after several reports emerged of blood clots among people who had received the vaccine. 

The head of WHO Africa said Thursday she hoped the controversy surrounding the British-Swedish jab would not deter people from getting the vaccine on the continent, where more than 16 million vaccine doses, mostly AstraZeneca, have been distributed under the Covax scheme. 

"A lot of countries have doubts" about AstraZeneca, Matshidiso Moeti told reporters. 

"But we hope that will not create doubts around anti-Covid vaccines in general." 

And in Britain, which has not halted the jab, officials insisted that an expected vaccine shortfall at the end of the month would not scupper plans to lift virus restrictions as the government has promised. 

Italy, the first European country to become engulfed by the pandemic, held a national day of mourning Thursday, with a ceremony in Bergamo, the northern city that became known as "Italy's Wuhan".

Italy chose March 18 for the memorial to coincide with the day in 2020 when the army had to step in to carry away scores of coffins from Bergamo's overwhelmed crematorium.

Images of coffin-laden camouflaged trucks crossing the city at night quickly became one of the symbols of the pandemic and still haunt the country today.

- 'Aggressive interventions' -

Meanwhile, vaccination efforts were under way in Chile, where 49 scientists and members of the armed forces working at a research station in the icy wastes of Antarctica got the jab, the first inoculations on the southernmost continent.

Antarctica was one of the last places on Earth to be affected by the virus, but on December 21, an outbreak was reported at a Chilean army base, with 36 people infected.

For some, vaccines have brought a sigh of relief -- especially for those working on the frontlines. 

Being vaccinated has allowed Colombian doctor Norberto Medina to return to his job at an intensive care unit in the capital Bogota feeling "more relaxed". 

Medina, 41, has lived all facets of the pandemic, seeing patients die on his ward, nursing others back to health -- and eventually staring death in the face when he contracted the virus himself.

"The pandemic has changed me forever," he told AFP after he returned to work, 54 days after he was diagnosed.

"It has made me more humane."

Agence France-Presse

EU drugs regulator plans to fast track variant-modified COVID vaccines

MILAN, Italy - Europe's medicines regulator is planning to speed up assessments of any COVID-19 vaccines that are modified to protect against variants of the virus, the head of the agency's COVID-19 task-force told Reuters on Friday.

Marco Cavaleri, chair of the vaccine evaluation team at the European Medicines Agency (EMA), said there should be no need for lengthy large-scale trials like those needed to evaluate the first COVID-19 vaccines, since tweaks for new variants can be tested on smaller groups.

"We are working on updated guidelines, assuming that we cannot ask for large Phase III trials. This will allow us to go faster," said Cavaleri.

"We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000," he told Reuters. He said the EMA would focus primarily on immune response data.

Drugmakers including Pfizer, Moderna and AstraZeneca have been testing their COVID-19 vaccines against several fast-spreading, more infectious variants of the novel coronavirus.

Variants which emerged in Brazil (known as P.1.), Britain (known as 20I/501Y.V1 or B.1.1.7) and South Africa (known as 20I/501Y.V2 or B.1.351) have already spread around the world, piling more pressure on governments struggling to tame the pandemic which has killed almost 2.5 million people.

These are the three major variants that are worrying scientists, with their spread raising the risk that newly-developed COVID-19 vaccines will need to be updated or tweaked to be effective against some variants, and that people may require one or more booster shots.

STREAMLINING

Last week, the U.S. Food and Drug Administration also said it is considering a rapid review process for the quick turnaround of new COVID-19 booster shots if variants emerge against which the vaccines do not provide protection.

Vaccine makers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID shots have been authorised for emergency use in Europe, have said they are preparing for the possibility that variants will emerge that could require tweaks to their vaccines.

Normally, an EMA approval requires extensive studies with large numbers, starting with safety and ending with efficacy.

"We will also try to streamline regulatory procedures doing something similar to what happens with flu vaccines. In short, without the drugmakers having to submit all the preliminary data again", Cavaleri said.

He added that the EMA is also aware that in the near future it may no longer be possible to do clinical trials with placebo for categories such as the elderly, due to rollout of current COVID-19 vaccines.

"In that case we could think about a head-to-head comparison with an already approved vaccine", he said.

Cavaleri also told Reuters Johnson & Johnson will file its vaccine formal application in the next few days.

"Probably as early as next week", he said, noting that the EMA has been conducting a rolling review of the vaccine for some time. "Mid-March is reasonable for the EMA decision," he said.

The EMA, he added, has been in contact to date with about 50 pharmaceutical companies working on COVID vaccines.

Regarding the Russia's Sputnik V vaccine, he said the agency is in constant contact with the company producing it.

"There is a constructive cooperation. If there are no problems with the answers we receive on the subject of the production phase, the rolling review could start within a matter of weeks," he said

The EMA is also in contact with the Chinese companies developing vaccines, particularly Sinovac Biotech, but the process for the Chinese vaccine is a few steps behind the Russian one, he said. 

(Reporting by Emilio Parodi, editing by Kate Kelland and Kirsten Donovan)

-reuters-

AstraZeneca to buy Alexion for $39 billion to expand in immunology

FRANKFURT - Britain's AstraZeneca has agreed to buy US drugmaker Alexion Pharmaceuticals for $39 billion in its largest ever deal, diversifying away from its fast-growing cancer business in a bet on rare-disease and immunology drugs.

The deal comes in a week that AstraZeneca said it was conducting further research to confirm whether its COVID-19 vaccine could be 90% effective, potentially slowing its rollout, and as a rival shot from Pfizer was launched in Britain and approved for use in the United States.

The British company said on Saturday that Alexion shareholders would receive $60 in cash and about $115 worth of equity per share - either in AstraZeneca's UK-traded ordinary shares or in dollar-denominated American Depositary Shares.

Based on a reference average ADR price of $54.14, that implies a total price of $175 per share. Alexion shares closed at around $121 apiece on Friday.

"It is a tremendous opportunity for us to accelerate our development in immunology, getting into a new segment of disease, a new segment of physicians, and patients we haven’t been able to cover so far," AstraZeneca Chief Executive Pascal Soriot told a media call.

Alexion's best-selling drug is Soliris, used against a range of rare immune-disorders including paroxysmal nocturnal hemoglobinuria (PNH), which causes anaemia and blood clots, and whose revenue rose 3.6% in the first nine months to $3 billion.

AstraZeneca hopes that an improved version of Soliris called Ultomiris has an even larger market potential. It expects more growth from introducing the target's rare-disease treatments to China and other emerging markets.

The British firm said the boards of both companies had approved the deal, which is expected to close in the third quarter of 2021.

AstraZeneca was once seen as leading the race to develop a COVID-19 vaccine, but has fallen behind Pfizer and its partner BioNTech, as well as Moderna, whose shots have shown greater efficacy in late-stage clinical trials.

With a planned capital increase of about $25 billion after the deal closure, Soriot is looking to harness a strong advance by AstraZeneca stock, driven by the stellar growth of new cancer drugs.

The shares have climbed about 70% through the past three years. A precursor cash call, on a much smaller scale, was a $3.5 billion issue last year to fund the purchase of rights to cancer drug Enhertu from Daiichi Sankyo.

RARE DISEASES

Despite generating billions in cash from treatments such as Soliris, one of the most expensive drugs in the world costing hundreds of thousands of dollars per patient, Alexion shares have struggled in recent years as investors have worried about competition heating up.

That had led it to be seen as a possible bid target.

Hedge fund and activist investor Elliott Management has urged Alexion to seek a buyer and in May spoke out publicly.

The fund, which had held private meetings with the company, said CEO Ludwig Hantson’s go-it-alone approach had failed to gain traction and opposed its plan to buy rivals to diversify its research pipeline.

Elliott first invested in Alexion in 2017 when the share price was only slightly lower than Friday's close of $120.98. Elliott did not immediately respond to a request for comment.

AstraZeneca said it expected the deal to immediately boost core earnings and to deliver pretax synergy gains of around $500 million per year. It also expects around $650 million in one-time cash costs during the three years following completion.

Speaking on an analyst call, 61-year-old Soriot said the deal should put to rest speculation he was on his way out, as he was determined to stay on board to see the strategic benefits of the transaction delivered.

Soriot also told reporters the deal was the result of exclusive talks and no competitive bidder was involved.

AstraZeneca finance chief Marc Dunoyer said a capital increase for the equity component of the transaction would take place on closure of the deal.

On AstraZeneca's COVID-19 vaccine, Soriot said it wasn't yet clear if the company would need results from a U.S. clinical trial before filing for approval with U.S. regulators.

Assuming positive results from that trial, the company should be able to submit the vaccine to US regulators within the next six weeks, he added. 

-reuters-

Vaccine still possible this year, despite trial pause: AstraZeneca

LONDON - Drugs giant AstraZeneca on Thursday said a COVID-19 vaccine could still be available by as early as the end of the year, despite a randomized clinical trial being paused.

"We could still have a vaccine by the end of this year, early next year," the UK-based company's chief executive Pascal Soriot said in comments at a media event.

AstraZeneca announced Wednesday it had "voluntarily paused" its trial of a drug developed alongside Oxford University after a UK volunteer developed an unexplained illness.

An independent committee was drafted in to review safety but the company said it was a "routine action" designed to maintain the integrity of the trials.

"We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity," Soriot said in a statement.

AstraZeneca's vaccine candidate is one of nine around the world currently in late-stage Phase 3 human trials.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31, and smaller groups are being tested in Brazil and elsewhere in South America.

The vaccine, called AZD1222, uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

The director of UK scientific research charity the Wellcome Trust, Jeremy Farrar, said there were often pauses in vaccine trials.

He told BBC radio in an interview that it demonstrated the importance of conducting vaccine trials properly, with independent oversight and the involvement of the regulator.

"In the end, the public must have absolute trust that these vaccines are safe and of course effective, and in the end will hopefully bring the pandemic to a close," he added.

Britain's chief scientific adviser, Patrick Vallance, on Wednesday said similar events should be expected but progress on vaccines and therapeutics was positive overall.

"Some will read out this year in terms of efficacy and safety," he told a Downing Street news conference.

"And I think there's a reasonable chance that... we can think about the possibility of vaccination next year sometime at larger levels."

UK Health Secretary Matt Hancock said the pause was "not necessarily" a set-back, and said a similar pause occurred recently but was "resolved without a problem".

Agence France-Presse

COVID-19 vaccine frontrunner pauses trial after unexplained illness

WASHINGTON -- Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.

The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a COVID-19 vaccine. 

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.

"We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," the spokesperson added.

It was not immediately clear where the patient was, or the nature and severity of their illness.

Holds during clinical trials are not uncommon, but this is thought to be the first time it has happened for a COVID-19 vaccine trial.

AstraZeneca is one of 9 companies currently in late-stage Phase 3 trials for their vaccine candidates.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31. 

The vaccine, called AZD1222, uses a weakened version of a common cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

Agence France-Presse 

US floats idea of early approval for eventual vaccine

WASHINGTON - The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness. 

A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times. 

"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination.”

But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.

"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision."

Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.

The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.

By the nature of the trials it is difficult to predict when reliable results will emerge.

Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo. 

Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.

As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials -- drawing criticism from public health officials in other countries, including the US.

Hahn also said that an emergency authorization would not necessarily cover everyone -- it might be granted for specific, high-risk groups.

"Our emergency use authorization is not the same as a full approval," he said.

Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.

In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.

More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.

"It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA's subservience to Trump," Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.

"We will not know about safety for many months."

Agence France-Presse

AstraZeneca starts UK coronavirus drug trial

LONDON - Pharma giant AstraZeneca said Tuesday it had begun a clinical trial of a drug designed to both prevent infection and treat people with COVID-19, with the first volunteers receiving doses.

The drug, known as AZD7442, is a combination of two antibodies and is being tested on 48 healthy people aged between 18 and 55, the company said.

"This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19," said Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca.

The company said the trial would help evaluate the safety of the drug and be used both to prevent the disease and to stop it from progressing in patients already infected. 

Results from the trial are expected by the end of this year.

This latest trial involving AstraZeneca, which has its global headquarters in Cambridge, eastern England, comes in addition to its partnership with the University of Oxford on the development of a separate coronavirus vaccine, which is said to have produced encouraging results.

News of the latest trial prompted shares in AstraZeneca to rise in early trading on Tuesday.

Agence France-Presse

AstraZeneca targets year-end for COVID-19 vaccine

PARIS - A coronavirus vaccine being developed by the University of Oxford and AstraZeneca should be available globally "at cost price" by year-end, the firm's director-general said Tuesday.

"Our objective is to bring the vaccine to everybody, (and) equally to do so on a not-for-profit basis so we shall be providing the vaccine at cost price," Pascal Soriot told RTL radio.

"At cost price that will be about 2.5 euros ($2.8) per unit.

"We hope to be able to produce a vaccine by the end of the year... perhaps a little earlier if all goes well" on the back of phase three results expected in the autumn, Soriot added in an interview.

Early results of a closely watched Phase 1/2 trial published this week in The Lancet suggest the vaccine candidate is safe and induces an immune response.

US group Johnson & Johnson has also vowed to deliver a vaccine at "non-profit" pricing.

In contrast rivals Pfizer, Merck and Moderna confirmed Tuesday to US lawmakers they would not sell vaccine at cost.

Soriot said the vaccine had performed well in stage 1 and 2 trials suggesting it offered good tolerability without serious side effects.

Stage 3 trials will now be carried out on a wider sample before product can finally be rolled out.

"We are working hand in hand with the regulators, we exchange our data on a daily basis to enable very swift evaluation. We are carrying out clinical trials which allows us to gain time," said Soriot.

He added the group had begun to produce product in "a number of regions" so they would be ready to start delivering "if the clinical trials are positive."

A separate trial in Wuhan, China, where the disease first emerged late last year and involving more than 500 people, showed most had developed widespread antibody immune response. 

The race is on in labs across the world to win the race to produce a vaccine to deal with the world health crisis the world has seen in a century.

More than 200 candidate vaccines are being developed with 23 having progressed to clinical trials with human volunteers.

Agence France-Presse

Scientists hunt pandemic hotspots in race to test vaccines

* Low transmission rates may scupper fast vaccine trials

* Vaccine volunteers need to be put at risk of infection

* Drug developers search for pandemic hotspots at home and abroad

LONDON/CHICAGO - The first wave of the COVID-19 pandemic may be waning. For vaccine developers, that could be a problem.

Scientists in Europe and the United States say the relative success of draconian lockdown and social distancing policies in some areas and countries means virus transmission rates may be at such low levels that there is not enough disease circulating to truly test potential vaccines.


They may need to look further afield, to pandemic hotspots in Africa and Latin America, to get convincing results.

"Ironically, if we're really successful using public health measures to stamp out the hot spots of viral infection, it will be harder to test the vaccine," said Francis Collins, director of the National Institutes of Health in the United States.

A vaccine is seen as essential to ending a pandemic that has killed nearly 370,000 people and infected more than 6 million so far, with world leaders looking at inoculation as the only real way to restart their stalled economies.

But running large-scale clinical trials of potential vaccines against a completely new disease at speed is complex, scientists say. Showing efficacy in those trials during a fluctuating pandemic adds extra difficulty - and doing so when outbreaks are waning makes it harder still.

"For this to work, people need to have a risk of infection in the community. If the virus has been temporarily cleared out, then the exercise is futile," said Ayfer Ali, an expert in drug repurposing at Britain's Warwick Business School.

"The solution is to move to areas where the infection is being spread widely in the community – that would be countries like Brazil and Mexico at the moment."

Vaccine trials work by randomly dividing people into a treatment group and a control group, with the treatment group getting the experimental trial vaccine and the control group getting a placebo.

All participants go back into the community where the disease is circulating, and subsequent rates of infection are compared. The hope is that infections within the control group will be higher, showing the trial vaccine is protecting the other group.

With COVID-19 epidemics in Britain, mainland Europe and the United States coming down from their peak and transmission rates of the coronavirus dropping, a key task for scientists is to chase fluctuating outbreaks and seek volunteers in sections of populations or in countries where the disease is still rife.

A similar problem emerged when scientists were seeking to test potential new vaccines against Ebola during the vast 2014 outbreak in West Africa. Then, drugmakers were forced to drastically scale back plans for large trials because their vaccines were only test-ready late in the epidemic when case numbers were dwindling. 

LOOKING ABROAD

Among the first COVID-19 vaccines to move into phase two, or mid-stage, trials is one from the U.S. biotech company Moderna and another being developed by scientists at Oxford University supported by AstraZeneca. The United States in July is planning to launch vast efficacy trials of 20,000 to 30,000 volunteers per vaccine.

Collins said U.S. health officials will tap government and industry clinical trial networks in the United States first and use mapping to detect where the virus is most active. They will also consider looking abroad if domestic disease rates fall too far, he said.

The U.S. government has experience in Africa of testing vaccines against HIV, malaria and tuberculosis.

"Africa is now beginning to experience lots of cases of COVID-19. We might very well want to run part of the trial there, where we know we can collect the data effectively," said Collins.

Adrian Hill, director of the Jenner Institute at Britain's Oxford University which has teamed up with AstraZeneca, started mid-stage trials last month which he said would aim to recruit around 10,000 people in Britain.

AstraZeneca obtains $1 billion from US to help fund coronavirus vaccine
He told Reuters that with COVID-19 disease transmission rates dropping in the UK there is a possibility that the trial would have to be halted if they didn't have enough infections to yield a result.

"That would be disappointing, and at the moment it's unlikely, but it's certainly a possibility," Hill said.

CHALLENGE TRIALS

Underscoring the level of concern in the industry, AstraZeneca's chief executive Pascal Soriot said his researchers were even contemplating running so-called "challenge" trials - where participants would be given the experimental vaccine and then deliberately infected with COVID-19 to see if it worked. Such trials are rare, high risk and hard to get ethical approval for.

As a more practical and swifter option, Soriot and others are looking to Brazil and other countries in South America, as well as parts of Africa where COVID-19 outbreaks are still growing and peaking, as ripe drug and vaccine testing grounds.

Difficulty recruiting candidates for mid-stage vaccine trials in countries where the COVID-19 pandemic is on the wane may be foreshadowed by the experience of doctors seeking infected cases for the World Health Organization's multi-country Solidarity trial of potential treatments for the disease - including the generic drug hydroxychloroquine and Gilead's remdesivir.

In the Swiss portion of that trial, for instance, it took three weeks to get all of the ethical and regulatory approvals from authorities, and another week to get all the drugs, said Oriol Manuel, an infectious disease expert and national coordinator of the Solidarity study in Switzerland.

"We were able to enroll some patients in (one trial centre in) Lausanne," Manuel said. "But when all centres were ready, the cases were fortunately disappearing."

-reuters-

Pharma chiefs see coronavirus vaccine by year-end, but challenges 'daunting'

GENEVA — Pharmaceutical company executives said Thursday that one or several COVID-19 vaccines could begin rolling out before 2021, but warned the challenges would be "daunting" as it was estimated that 15 billion doses would be needed to halt the pandemic.

Well over 100 labs around the world are scrambling to come up with a vaccine against the novel coronavirus, including 10 that have made it to the clinical trial stage.

"The hope of many people is that we will have a vaccine, hopefully several, by the end of this year," Pascal Soriot, head of AstraZeneca, told a virtual briefing.

His company is partnering with the University of Oxford to develop and distribute a vaccine being trialed in Britain.

Albert Bourla, head of Pfizer, meanwhile said that his company, which is conducting clinical trials with German firm Biontech on several possible vaccines in Europe and the United States, also believed one would be ready before the end of the year.

"If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can... have a vaccine around the end of October," he said.

It can take years for a new vaccine to be licensed for general use, but in the face of the COVID-19 pandemic, experimental vaccines shown to be safe and effective against the novel coronavirus could likely win approval for emergency use.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which organised Thursday's briefing, highlighted the "daunting" challenges facing the industry in the push for a vaccine.

'RUNNING AGAINST TIME'

One challenge, which may seem counterintuitive, is that transmission rates are rapidly declining in Europe where some of the trials are taking place.

Soon they will be too low to properly conduct clinical vaccine trials in a natural setting, Soriot said, adding that so-called "human challenge" studies in which people are intentionally exposed to the virus to test efficacy, were not considered ethically acceptable with COVID-19.

"We are running against time," he said.

The novel coronavirus has killed more than 355,000 people and infected at least 5.7 million worldwide in a matter of months.

IFPMA director Thomas Cueni pointed to estimates that the world will need some 15 billion doses to stop the virus, posing massive logistical challenges.

He stressed that the industry was committed to ensuring equitable access to a future vaccine, but acknowledged that "we will not have sufficient quantities as from day one, even with the best efforts."

Once a working vaccine is developed, one of the biggest obstacles to putting out the amount needed could surprisingly be that there are not enough glass vials to store the doses in.

"There are not enough vials in the world," Soriot said, adding that AstraZeneca, like a number of other firms, was looking into the possibility of putting multiple doses in each vial.

IP 'FUNDAMENTAL'

Paul Stoffels, vice chairman and chief scientific officer at Johnson and Johnson, meanwhile said that if 15 billion doses were needed, a number of different vaccines would be necessary to satisfy the initial demand.

"Not all vaccine candidates could go all over the world depending on features, so somewhere between five and 10 will definitely be needed to serve the whole world," he said.

One challenge could be that some of the vaccines being worked on require storage at very low temperatures, which could be difficult in places lacking the proper infrastructure.

While stressing the need for solidarity and for ensuring fair and equitable distribution of a COVID-19 vaccine, the pharmaceutical chiefs flatly rejected any suggestion that intellectual property rights should be waived on vaccine research.

"IP is absolutely fundamental to our industry," GSK chief Emma Walmsley said.

Soriot meanwhile pointed out that pharmaceutical companies are currently investing billions of dollars with little chance of recuperating the costs.

"If you don't protect IP, then essentially there is no incentive for anybody to innovate," he said.

Agence France-Presse

US orders 300 million doses of potential COVID-19 vaccine

The US government has ordered 300 million doses of a potential COVID-19 vaccine being developed by AstraZeneca and Oxford University and hopes first doses can be made available by October, the Department of Health and Human Services said Thursday.

"This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021," HHS Secretary Alex Azar said in a statement. 

The US has the world's worst coronavirus affliction, with over 1.52 million cases, including 91,664 deaths, according to data from its Centers for Disease Control and Prevention as of May 20. 

-reuters-

Oxford university, pharma group partner over coronavirus vaccine

LONDON - British pharmaceuticals group AstraZeneca has partnered with the University of Oxford to develop and distribute a coronavirus vaccine being trialed in the UK, the pair announced Thursday.

Human trials of the vaccine developed by the university's Jenner Institute began last week, with hundreds of people volunteering to be part of the study that has received £20 million ($24.7 million, 22.6 million euros) in government funding.

"The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford," said a joint statement. 

"Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine."

Data from the first phase trial could be available next month, the statement said. 

"Advancement to late-stage trials should take place by the middle of this year," it added.

The news comes after US scientists hailed the results of a major drug trial. People treated with Remdesivir recovered about 30 percent faster than those on a placebo.

Agence France-Presse