Global report: India Covid-19 cases pass 500,000 as Texas revives lockdown
"LONGTERM - Why a vaccine may not be enough to end the pandemic "How Long Will a Vaccine Really Take? "THE TESTS - expert comments on different types of test for COVID-19 "‘We’re Flying Blind’: Why Testing for Coronavirus Antibodies Will Matter"" " "
Related: #60Minutes investigation reveals Trump knowingly allowed flawed #COVID19 antibody tests to circulate, leading to inaccurate data about virus spread, creating data to support re-openings, and potentially causing thousands more preventable deaths" https://investorshub.advfn.com/boards/read_msg.aspx?message_id=156568152
US reports highest daily new infections as EU says it may exclude US from list of ‘safe countries’; Brazil records nearly 47,000 new cases
Sun 28 Jun 2020 04.09 AEST First published on Sat 27 Jun 2020 15.38 AEST
An Indian health worker tests for Covid-19 as inections in the country rise past 500,000. Photograph: Hindustan Times/Getty Images
India .. https://www.theguardian.com/world/india .. passed half a million coronavirus infections as experts advised the government to prioritise reducing mortality over containing the spread of Covid-19, while in the US surging infections prompted two of the biggest states to bring back coronavirus controls.
Texas became the first state to revive lockdown measures, as new daily infections surged to nearly 6,000 and a senior official warned that hospitals risked being overwhelmed in the near future. “We opened too quickly,” Lina Hidalgo, judge for Harris county which includes Houston, said at a press conference .. https://abc13.com/stay-home-work-safe-order-lina-hidalgo-coronavirus-texas-reopen/6270984/ .. on Friday.
Florida, which has also seen record infection rates, banned alcohol sales in bars and at least one county in the state said it would close beaches over the Fourth of July weekend.
Globally coronavirus cases are rising towards 10 million, with nearly half a million deaths. Brazil .. https://www.theguardian.com/world/brazil .. and the US have the largest outbreaks, between them accounting for more than a third of the global toll.
The fourth biggest outbreak is in India, where health authorities reported 17,000 new coronavirus cases on Saturday, taking the country’s total infections past 500,000, according to Johns Hopkins university figures.
In Delhi, hotels, wedding halls, an ashram and railway coaches are being repurposed for coronavirus care, as hospitals filled beyond capacity have been forced to turn patients away.
So far India has recorded more than 15,000 deaths from Covid-19, a lower ratethan in many Western countries. Health experts are urging the government to prioritise keeping mortality down as the infection spreads.
“Our focus should be on preventing deaths and not really getting bogged down because of the numbers. Numbers are going to increase,” said Dr Manoj Murhekar, a member of India’s main coronavirus task force and director of the National Institute of Epidemiology.
As these countries battle their first wave, several countries that have largely suppressed the virus are trying to contain fresh regional outbreaks – from Beijing to Germany – and stop them escalating into second major wave of infections.
Chancellor Angela Merkel warned on Saturday that the pandemic was far from over, and said everyone had “joint responsibility” for keeping the virus in check. The country has put a Western region of about 500,000 people back under lockdown after hundreds of workers at a meat processing plant tested positive.
“Germany has gotten through the crisis well so far, but that doesn’t mean we are protected, that the risk has been averted,” she said. “That is not the case, as is demonstrated by these regional outbreaks.”
China .. https://www.theguardian.com/world/china .. also reported an increase in new Covid-19 cases, the day after health authorities said they expected an outbreak in Beijing to be under control soon. There were 17 new cases in the capital, where several neighbourhoods have been locked down and a negative Covid test is required for travel to other parts of the country.
As infections rise, Swiss pharmaceutical firm Roche says it is unable to meet demand for molecular tests to identify active Covid-19 infections.
‘The demand exceeds our production,’ chairman Christoph Franz told the Swiss daily Tages-Anzeiger. The decision on where tests were shipped to depended, among other things, on infection rates and the availability of diagnostic equipment.
On Friday Brazil recorded 46,860 new infections, its third consecutive day when that total was over 40,000.
The new figures came amid warnings that the spread through smaller towns in Brazil’s interior risked a return of infections in major cities, dubbed a “boomerang effect,” as a lack of specialised medical treatment forced patients into larger urban centres.
The Brazilian government has reached a deal with Oxford University and pharmaceutical company AstraZeneca to produce a promising coronavirus vaccine, one of several currently undergoing tests worldwide.
It will start manufacturing more than 30m doses from December, allowing it to rapidly start inoculations next year if the vaccine is proved effective; in total the $127m deal covers 100m vaccines, for a country of 210 million people. Advertisement
The US also reported its highest daily number of infections, with more than 40,000 cases. In the first coronavirus taskforce briefing since April – which was not held at the White House and had no presidential appearance – showed current infection rates outstripped the peak of April and May.
European Unioncountries failed to settle on Friday on a final “safe list” of countries whose residents could travel to the bloc from July, with the United States, Brazil and Russia looked set to be excluded .. https://www.theguardian.com/world/2020/jun/26/european-union-us-visitors-coronavirus . Ambassadors from the 27 EU members convened from Friday afternoon to establish criteria for granting quarantine-free access from next Wednesday.
A redrawn text of 10-20 countries was put to ambassadors, but many said they needed to consult first with their governments, diplomats said. The list did not include the United States, Brazil or Russia, one diplomat said. Discussions were continuing overnight, with the EU countries expected to give informal replies by Saturday evening, people familiar with the matter said.
There is broad agreement that the bloc should only open up to those with a similar or better epidemiological situation, but there are questions about how to assess a country’s handling of the epidemic and the reliability of data.
In other coronavirus developments:
Global infections stood at 9,859,738, with deaths approaching 500,000.
A federal judge in New York has blocked the state from enforcing coronavirus restrictions limiting indoor religious gatherings to 25% capacity when other types of gatherings are limited to 50%.
Another US federal judge ordered the release of children held with their parents in US immigration jails and denounced the Trump administration’s prolonged detention of families during the coronavirus pandemic.
The Victorian state government in Australia is seeking legal advice to see if it can force travellers returning from overseas to have a coronavirus test, after a large number of cases in recent days around the city of Melbourne.
The Argentine government said on Friday night it would reintroduce strict quarantine measures in the Buenos Aires metropolitan area. The measures would last 17 days and begin on 1 July.
Religious leaders question ethics of Oxford University developing coronavirus vaccine using cell lines from aborted foetus
"LONGTERM - Why a vaccine may not be enough to end the pandemic"
Religion interfering with accepted science yet again.
They should mind their flocks, and leave the rest to others.
By federal politics reporter Stephanie Borys
Posted 6hours ago, updated 5hours ago
VIDEO
One of Australia's most senior religious leaders says he would likely boycott the COVID-19 vaccine being developed by Oxford University, on ethical grounds.
Key points:
* Sydney's Anglican Archbishop has written to Scott Morrison over concerns about a potential COVID-19 vaccine
* The Government has expressed intent to purchase the vaccine developed by Oxford University and AstraZeneca
* However, the vaccine has links to an aborted foetus, which is common practice in medical research
The Federal Government has signed an international deal that would provide all Australians free access to the UK vaccine, being worked on by Oxford scientists and pharmaceutical firm AstraZeneca, if it is approved for use.
But Anglican Archbishop of Sydney Glenn Davies said there were ethical questions about the potential vaccine, because scientists have used cell lines from an electively aborted foetus.
[...]
Transparency and options
For decades, scientists have used human cells that come from elective abortions to make vaccines such as rubella and chicken pox.
The information is publicly available and the Archbishop was questioned why he had not raised concerns about other inoculations.
"To be perfectly honest I didn't know that until this week," he said.
"Once I know something that is morally compromised, then it is my job to speak out about it.
Coronavirus: Oxford University vaccine trial paused after participant falls ill
"LONGTERM - Why a vaccine may not be enough to end the pandemic"
1 hour ago
Reuters
Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had an adverse reaction in the UK.
AstraZeneca described it as a "routine" pause in the case of "an unexplained illness".
The outcome of vaccine trials is being closely watched around the world.
The AstraZeneca-Oxford University vaccine is seen as a strong contender among dozens being developed globally.
Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US as well as in the UK, Brazil and South Africa. Phase 3 trials in vaccines often involve thousands of participants and can last several years.
What have the developers said?
All international trial sites have now been put on pause while an independent investigation reviews the safety data before regulators decide whether the trial can restart, the BBC's Medical Editor Fergus Walsh reports.
"In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully", an Oxford University spokesperson said.
This is the second time the Oxford coronavirus vaccine trial has been put on hold, our correspondent notes. Such events are routine in major trials, and happen any time a volunteer is admitted to hospital when the cause of their illness is not immediately apparent.
It is thought the trials could resume in a matter of days.
US President Donald Trump has said he wants a vaccine available in the US before 3 November's election, but his comments have raised fears that politics may be prioritised over safety in the rush for a vaccine.
On Tuesday, a group of nine Covid-19 vaccine developers sought to reassure the public by announcing a "historic pledge" to uphold scientific and ethical standards in the search for a vaccine.
AstraZeneca is among the nine firms who signed up to the pledge to only apply for regulatory approval after vaccines have gone through three phases of clinical study.
Industry giants Johnson & Johnson, BioNTech, GlaxoSmithKline, Pfizer, Merk, Moderna, Sanofi and Novavax are the other signatories.
They pledged to "always make the safety and well-being of vaccinated individuals our top priority".
The World Health Organization (WHO) says nearly 180 vaccine candidates are being tested around the world but none has yet completed clinical trials.
The organisation has said it does not expect a vaccine to meet its efficacy and safety guidelines in order to be approved this year because of the time it takes to test them safely.
Similar sentiments have been shared by Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers. The industry body represents the companies that signed the pledge.
Despite this, China and Russia have begun inoculating some key workers with domestically developed vaccines. All of them are still listed by the WHO as being in clinical trials.
Meanwhile, the US national regulator, the Food and Drug Administration (FDA), has suggested that coronavirus vaccines may be approved before completing a third phase of clinical trials.
Last week it also emerged that the US Centers for Disease Control and Prevention had urged states to consider waiving certain requirements in order to be ready to distribute a potential vaccine by 1 November - two days before the 3 November presidential election.
Although President Trump has hinted that a vaccine might be available before the election, his Democratic rival Joe Biden has expressed scepticism that Mr Trump will listen to scientists and implement a transparent process.
What will Trump do to win? Here are nine possible October surprises — and one November surprise. "Once a CON MAN...always..." [...] There’s only one thing he almost certainly won’t do: Admit that he made a lot of mistakes because he was unprepared for the job, plead for forgiveness and promise to do better in a second term. That would be almost as much of a shock as if he were to unveil an actual plan to fight the novel coronavirus. It’s much easier to imagine Trump approving a coronavirus vaccine before the conclusion of Phase 3 trials, thereby exposing innocent people to potentially fatal side effects for his own political gain. https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157966297
Andrew tested positive for coronavirus in March and then in September. What does reinfection mean for immunity and a vaccine?
"LONGTERM - Why a vaccine may not be enough to end the pandemic "How Long Will a Vaccine Really Take?"
ABC Health & Wellbeing By health reporter Olivia Willis Posted Tuesday 13 October 2020 at 7:48am
The first documented case of COVID-19 reinfection happened in August in Hong Kong. (Getty Images: krisanapong detraphiphat)
When Andrew tested positive for coronavirus a couple of weeks ago, he was surprised.
Not because he thought he had taken all the right precautions to prevent catching it or the fact his symptoms were mild — but because it wasn't the first time he had received a positive COVID-19 test result.
The 34-year-old Australian expat, who lives in San Francisco, says he contracted coronavirus back in March after returning to the US from a friend's wedding in Colombia.
On a connecting flight home from Miami, Andrew sat next to an older woman who had just stepped off a cruise ship — and was displaying symptoms of COVID-19.
"She was quite ill and I was taking every precaution … but I got back to San Francisco and about a week later, I got sick really quickly," Andrew said.
For two weeks, the disease left him bedbound, and at times gasping for air.
"I went through all the COVID symptoms that are listed: body aches, really high fever, I hallucinated and had trouble breathing."
Andrew, who has no pre-existing health conditions and describes himself as "reasonably healthy", lost five kilograms in two weeks.
"I didn't get hospitalised ... but there was a time I really wasn't breathing well. It wasn't a super-pleasant experience," he said.
"There wasn't really much intervention from doctors, I just kind of got better."
Over the following months, Andrew recovered and returned to good health.
"At first my lungs were a little overworked, walking up stairs and what have you, but then I was back to normal," he said.
Unable to return to work as a musician because of lockdown rules, Andrew picked up some part-time work in a warehouse.
In August, he travelled to the Midwest for a family celebration, and decided to get another COVID-19 test on his return.
"I got a test when I got back ... and that was negative".
But in late September, six months after he had first tested positive to coronavirus, Andrew began to feel like he was coming down with a cold.
"I started getting a sore throat, body aches … I thought maybe I'm just a bit rundown," he said.
To be on the safe side, he organised to get another coronavirus test. To his shock, it came back positive.
Andrew said the second time round the illness has been "less intense in every way".
"This time, I'm just really tired," he said. "There were a couple of days where I felt like I had a cold, then it would go and come back … but I'd say that I'm back to normal now."
COVID-19 reinfection — or one prolonged illness?
Andrew suspects his most recent COVID-19 symptoms and positive test result represent a rare case of reinfection.
But it's impossible to know if someone has been infected with SARS-CoV-2 twice without examining the genetic code of the virus both times to see if the samples are distinct, said Akiko Iwasaki, a professor of immunobiology at Yale University.
"There are a lot of suspected cases, unfortunately for which we don't have a viral genome so we cannot confirm, [that] may reflect reinfection, especially if there is a negative period that stands for months," said Professor Iwasaki, who has been following cases of reinfection closely.
In Andrew's case, this genetic testing hasn't been done, and US authorities are yet to confirm whether it is a case of reinfection.
It's possible for a person to be infected with COVID-19 and test positive for the virus weeks, or even months, after they first become sick because of leftover viral fragments of RNA.
When Andrew became ill in September, it had been six months since he was first infected, and he had a negative test result in the interim. (Getty Images: Jasmin Merdan)
But there are a handful of confirmed cases that demonstrate reinfection with COVID-19 is possible.
"They tend to be more rare, but there are a couple of dozen already reported throughout the world," Professor Iwasaki said.
Soon after, researchers in the US reported a 25-year-old man from Nevada had tested positive for COVID-19 for a second time, and that the infections were caused by slightly different strains.
"We're just seeing the very first reports of these confirmed cases coming out, but I suspect we'll see more as the pandemic progresses," Professor Iwasaki said.
Measuring how often reinfection occurs is difficult, not only because asymptomatic cases of reinfection are likely to be missed, but because it's not clear how many people are re-exposed to SARS-CoV-2 without getting infected.
Still, with only a handful of people confirmed to have had COVID-19 twice, and more than 37 million COVID-19 infections recorded worldwide, reinfection appears to be the exception, not the rule.
Re-infection cases to be expected, experts say
Professor Iwasaki said it was hard to say at this point what evidence of COVID-19 reinfection suggests about the body's ability to generate immunity to the virus.
"I think we have to keep an open mind, but there is a possibility that the immune defence against this virus doesn't last that long," she said.
Immunologist Menno van Zelm of Monash University said it was too early to say what the implications may be, but that he wasn't overly concerned.
He said the handful of reinfection cases were more likely a reflection of the varying degrees of immunity generated in a large population, rather than evidence that COVID-19 natural infection does not confer strong immunity.
"In the larger scheme of things, this will always happen," Dr van Zelm said.
"We expect people to get immunity to the virus, but it's a large scale. Some people will have a better immune memory than others.
"The most important thing we find out now is to see how large the group is that is vulnerable to reinfection, and how severe those reinfections are."
[Inside: India set to take #1 spot from the U.S.A.] How fast is coronavirus growing around the world? Data sources: Johns Hopkins Coronavirus Resource Center, Our World in Data, The COVID Tracking Project, ABC
Both scientists agreed that seeing cases of COVID-19 reinfection was not particularly surprising given what we know about other coronaviruses.
"For some viruses, like measles, once you're infected and you recover, you will never be sick from it again because the immunity is basically for your lifetime," Professor Iwasaki said.
"But for other viruses … the coronaviruses — typically your immune response doesn't last very long and you can get reinfected with the same virus."
Most of the reported cases of COVID-19 reinfection appear to be milder the second time around, suggesting that the immune response is working as it should — limiting the severity of the second infection, if it can't prevent reinfection altogether.
But that isn't always the case, and some people have developed worse disease the second time round, Professor Iwasaki said.
"That may be because of a higher dose of [virus], or that their immune response just wasn't good enough for the second infection," she said.
Scientists are still trying to understand what kind of immunity is generated from a COVID-19 natural infection, how long that immunity typically lasts, and how many (and what type of) antibodies are needed to mount an effective response.
While some research suggests antibodies deteriorate quickly, or are not produced in large numbers (especially in those with mild or no symptoms), Dr van Zelm said his research showed encouraging signs of a strong, lasting immunity.
"We're following patients up to half a year after their initial infection, and we see that most of the patients still have detectable antibodies," he said.
"We also now see that the T and B cells that are specifically generated to the virus and can recognise it, they seem to be much more stable."
Vaccines can elicit stronger response
One of the biggest concerns about COVID-19 reinfection is what implications it might have for achieving herd immunity. That's when enough people are exposed to viral proteins (either naturally or from a vaccine) and gain immunity to stop the virus from spreading further.
"In some people, the level of virus that replicated the second time is quite high, meaning they could become the vector to transmit the virus the second time around," Professor Iwasaki said.
"So that would not serve the purpose of herd immunity, because the whole purpose of herd immunity is that the immune person will no longer transmit the virus."
But a vaccination can be designed to elicit a stronger and longer-lasting immune response than a natural infection.
"I think relying on natural infection to establish herd immunity is not a viable option, not only because of reinfection, but because of the risk of severe disease and death in the population," Professor Iwasaki said.
"That's why we need a strong vaccine that surpasses the immune response that's generated by natural infection, to protect people from infection and reinfection."
Could certain COVID-19 vaccines leave people more vulnerable to the AIDS virus?
"LONGTERM - Why a vaccine may not be enough to end the pandemic"
CanSino Biologics’s experimental COVID-19 vaccine is one of at least four using an adenovirus that some worry could increase HIV susceptibility. CHINA DAILY CDIC/REUTERS
By Jon CohenOct. 19, 2020 , 6:30 PM
Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
Certain COVID-19 vaccine candidates could increase susceptibility to HIV, warns a group of researchers who in 2007 learned that an experimental HIV vaccine had raised in some people the risk for infection with the AIDS virus. These concerns have percolated in the background of the race for a vaccine to stem the coronavirus pandemic, but now the researchers have gone public with a “cautionary tale,” in part because trials of those candidates may soon begin in locales that have pronounced HIV epidemics, such as South Africa.
Some approved and experimental vaccines have as a backbone a variety of adenoviruses, which can cause the common cold but are often harmless. The ill-fated HIV vaccine trial used an engineered strain known as adenovirus 5 (Ad5) to shuttle into the body the gene for the surface protein of the AIDS virus.In four candidate COVID-19 vaccines now in clinical trials in several countries, including the United States, Ad5 similarly serves as the “vector” to carry in the surface protein gene of SARS-CoV-2, the viral cause of the pandemic; two of these have advanced to large-scale, phase III efficacy studies in Russia and Pakistan.
In today’s issue of The Lancet, four veteran researchers raise a warning flag .. https://doi.org/10.1016/S0140-6736(20)32156-5 .. about those COVID-19 vaccine candidates by recounting their experience running a placebo-controlled AIDS vaccine trial dubbed STEP. An interim analysis of STEP found that uncircumcised men who had been naturally infected with Ad5 before receiving the vaccine became especially vulnerable to the AIDS virus. The vaccine, made by Merck, had been the leading hope for what was then a 20-year search for a shot that could thwart HIV. But after the STEP results appeared, the field went into a tailspin. “It took a decade to recover,” says one of the co-authors of the Lancet correspondence, Lawrence Corey of the Fred Hutchinson Cancer Research Center.
Corey, who now co-leads the COVID-19 prevention network in the United States that is testing vaccines at the behest of the National Institutes of Health, says he and his co-authors went public because Ad5-based COVID-19 vaccines may soon be tested in populations with high HIV prevalence and thus a greater risk of accidental infection during a clinical trial. “If I were in a sub-Saharan African country and making a decision as to what I would want for my country for a general population use of a SARS-CoV-2 vaccine, I don’t see why I would pick an Ad5 vector [vaccine] when there are many other alternative choices,” Corey says.
The backfire in STEP—which evaluated the efficacy of the Merck vaccine in people at high risk of HIV infection in the Americas and Australia—also appeared in a second study, dubbed Phambili, of the same vaccine. It was taking place simultaneously in South Africa and was stopped early because of the STEP data.
Precisely how Merck’s Ad5 vaccine increased the risk of HIV transmission in STEP and Phambili remains murky. The Lancet editorial spells out several possibilities, including dampening of HIV immunity, enhancing replication of the AIDS virus, or setting up more target cells for it.
In addition to the Ad5 COVID-19 vaccine candidates, several other leading vaccines, including ones made by Johnson & Johnson and AstraZeneca/the University of Oxford, use different adenoviruses as vectors. There’s no evidence that any of those adenoviruses increases the risks of an HIV infection.
- I don’t see why I would pick an Ad5 vector [vaccine] when there are many other alternative choices. Lawrence Corey, Fred Hutchinson Cancer Research Center -
Of the Ad5-based COVID-19 vaccine candidates, from China-based CanSino Biologics, has developed the furthest. In a Lancet report in May, researchers from the company recognized the “controversial” possibility of their vector increasing the risk of HIV infection and said they would watch for it in the candidate’s trials. CanSino’s COVID-19 vaccine is being tested in efficacy trials in Russia and Pakistan that together hope to enroll more than 40,000 people, and the company is discussing starting studies in Saudi Arabia, Brazil, Chile, and Mexico.
China has already approved a CanSino vaccine against Ebola that uses the Ad5 vector. Yu Xuefeng, CanSino’s CEO, tells Science the risk of increased HIV susceptibility may be limited to Ad5 vaccines that produce an AIDS virus protein. “There’s no clear answer yet,” Yu says. “We certainly haven’t seen anything with the Ebola vaccine.” The company’s Ebola vaccine was tested in a population in Sierra Leone that, he notes, had a relatively high HIV prevalence, making it more likely to have detected the problem if it existed.
Russia’s Gamaleya Research Institute has a COVID-19 vaccine candidate that uses a combination of Ad5 and Ad26 vectors; it’s now in an efficacy trial in that country.
Last week, ImmunityBio received approval from the U.S. Food and Drug Administration to begin human trials of its COVID-19 vaccine, which uses Ad5 as a vector. The first trial will take place in Newport Beach, California, but Patrick Soon-Shiong, the company’s CEO, says he also hopes to test it in South Africa, where he grew up and went to medical school.
He calls the STEP study results “very, very fuzzy” and stresses that ImmunityBio’s Ad5 has four deleted genes that reduce the immune responses it triggers. “It’s 90% muted,” he says.
ImmunityBio is discussing the risks with scientists and regulators in South Africa of a trial there to test its modified Ad5 COVID-19 vaccine. The informed consent process for that proposed study would tell participants about potential risks given the previous STEP and Phambili results.
Soon-Shiong emphasizes that his company’s experimental COVID-19 vaccine, unlike every other candidate that uses an adenovirus vector, presents two different SARS-CoV-2 genes and might therefore offer more protection from infection or disease. Why only test this in wealthy enclaves of Southern California, he asks? “Why not South Africa? Why not for the underserved people of the world?”
Pediatrician Glenda Gray, who heads the South African Medical Research Council and was the protocol chair of Phambili, has taken part in several discussions with the ImmunoBio team. “When [Soon-Shiong] contacted South Africa, we were obviously quite concerned,” Gray says. “All of us who were in Phambili and quite traumatized by what happened asked whether there was an appetite to do something in South Africa.”
But after several months of deliberations, the South Africans concluded that regulators should consider a small trial of the vaccine there in people at low risk of HIV infection, Gray says. “We decided not to throw the baby out with the bath water just yet,” she adds. “If it does go ahead in South Africa, there has to be huge consultation with communities, and we have to make doubly sure that the participants understand what happened in the past.”
Gray says South Africa appreciates ImmunoBio’s offer to allow the country to manufacture the product. “We’re in the middle of a COVID-19 epidemic in South Africa, and we don’t know if we’ll ever get access to the current suite of vaccines” produced elsewhere, she says.
The decision to move forward, she insists, has to be left to South African scientists, regulators, and ethics committees. “It’s incredibly patronizing for people to determine what science is good or bad for other countries,” she says. “Everyone knows about Phambili and STEP, and the scientists understand that there’s an important need to be cautious.”
Gray, who has co-authored papers about HIV vaccines with Corey and the other three authors of the Lancet correspondence, says there are no easy answers. “What if this vaccine is the most effective vaccine?” she asks. “If this works out to be an important vaccine, we’ll have some experience with it.”
Jon Cohen Jon is a staff writer for Science. Email Jon Twitter
U.K. Approves Pfizer Coronavirus Vaccine, a First in the West
"LONGTERM - Why a vaccine may not be enough to end the pandemic"
Don't think Trump would be happy at this. Johnson just took an arrow from his 'I'm the best' future quiver.
The emergency approval, ahead of the United States and the European Union, clears the way for Britain to begin mass inoculations. “Help is on its way,” one official said.
The government in London has been vague about how quickly it could stock hospitals, but doctors and nurses were preparing to begin vaccinating their colleagues within days. Andrew Testa for The New York Times
By Benjamin Mueller
Dec. 2, 2020Updated 7:06 p.m. ET
LONDON — Britain gave emergency authorization on Wednesday to Pfizer’s coronavirus vaccine, leaping ahead of the United States to become the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.
The decision cleared the way for a vaccination campaign with little precedent in modern medicine, encompassing not only ultracold dry ice but also a crusade against anti-vaccine misinformation.
European regulators on Wednesday cast doubt on the rigor of Britain’s review and said that the authorization was limited to specific batches of the vaccine, a claim that Pfizer denied and British officials did not address.
[...]
American regulators have argued that they lag behind — if only by a matter of days — because they are virtually alone in reanalyzing thousands of pages of raw data from vaccine trials before approval. Backers of that approach say it is the only way to minimize unintended damage, in lives and in public trust, from vaccines not working.
British and European regulators lean more heavily on the companies’ own analyses, auditing their figures occasionally but otherwise grounding their decisions on vaccine makers’ reports. While the more cautious American approach can be valuable, some scientists said the Europeans subject vaccine makers to considerable scrutiny, and it is imperative to move quickly to curb the suffering wrought by the pandemic.
[...]
As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of convincing people to take them. In Britain, the source of some of the most virulent modern disinformation about vaccines, just over half of people have said in surveys they would definitely accept an inoculation.
How scary is omicron? Scientists are racing to find answers.
"LONGTERM - Why a vaccine may not be enough to end the pandemic"
In a few weeks, researchers expect to understand more about how well vaccines fare when they do battle with the new variant
VIDEO - How coronavirus variants like omicron form and spread Coronavirus variants like omicron, delta and mu are an expected part of the virus's life cycle, but vaccines can prevent more infectious variants from forming. (John Farrell, Hadley Green/The Washington Post)
By Carolyn Y. Johnson and Joel Achenbach Today at 1:01 p.m. EST
Like most scientists, he was shocked by the sheer number of mutations. He also knew exactly what to do next.
Shi runs a high-containment laboratory at the University of Texas Medical Branch, in Galveston, and collaborates closely with Pfizer .. https://www.nejm.org/doi/full/10.1056/NEJMc2102017 . Over Thanksgiving, his team began engineering a replica of the new variant to test against the antibodies generated by vaccines. But it doesn’t happen overnight: It will take about two weeks to build the omicron replica, another few days to confirm that it’s an accurate facsimile, and one more week to pit the virus against blood samples from vaccinated people.
Shi and colleagues around the world are in an urgent race to gauge the danger posed by omicron, which is rapidly seeding itself everywhere. As the tally of cases mounts, what happens inside labs over the next few weeks will help scientists determine the true potential of the virus, tipping off government officials and pharmaceutical companies about whether they need to revise their global vaccination campaign.
His message: Be patient. Wait for the data.
“I think there is a lot of overreaction, and we just have to sit tight,” Shi said. “There are no results yet, these are just the mutations. What does that mean? We have to see.”
Instead of running time-consuming large-scale trials that depend on waiting for people to get ill, vaccine-makers expect to be able to show that their revamped vaccines are safe and effective by measuring immune responses in blood samples taken from study participants.
“We can turn the key relatively quickly and start to produce the updated vaccine,” Pfizer’s Jansen said.
“Our premise was that this would happen,” said Andrew Allen, chief executive of Gritstone Bio, a company whose vaccine formula is designed to rouse protection from T cells, the immune-system warriors that kill infected cells. “It is naive to think that the very first vaccine we made in the very first hot minutes of the pandemic would be the very best vaccine we could make.”
The idea behind Gritstone’s vaccine is that a broader set of immune defenses will free the world from constantly trying to play catch-up to the latest mutant strain of the virus.
But unless more of the world becomes vaccinated, the frenzy of worry is likely to continue to repeat.
“If we don’t develop systems to immunize the whole world in three months, instead of three years, we are not going to be successful against these kind of pandemic threats,” Graham said. “Because viruses adapt and they change, and unless we develop generalized global immunity more readily, we will always be faced with chasing our tail.”
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