The Anatomy of a Vaccine: The Path To Recovery?

[therock]

https://www.straitstimes.com/world/europe/eu-warns-not-enough-covid-19-vaccines-for-all-in-europe-until-2022

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BRUSSELS (REUTERS) - Only a share of the European Union population can be inoculated against the new coronavirus before 2022, should an effective vaccine be available, EU officials said in an internal meeting, as governments remain split on vaccination plans.

The warning comes in spite of the fact that the 27-nation bloc, with a population of 450 million, has secured more than 1 billion doses of potential Covid-19 vaccines from three drugmakers. It is negotiating the booking of another billion vials with other companies.

As a global scramble to secure shots accelerates, experts caution that not every potential vaccine may prove to be effective.

"There will not be sufficient doses of Covid-19 vaccines for the entire population before the end of 2021," a European Commission official told diplomats from EU states in a closed-door meeting on Monday, a person who attended it told Reuters.

A second official confirmed the statement. An EU Commission spokesman was not immediately available for comment.

There is still no effective Covid-19 vaccine, but the first shots could be available at the beginning of next year, the Commission said earlier in October.

 

[noobcarbuyer]

7 minutes ago, therock said:

https://www.straitstimes.com/world/europe/eu-warns-not-enough-covid-19-vaccines-for-all-in-europe-until-2022

 

Sounds about right. 

It's all about manufacturing and logistical bottle necks / stress points that could impede the smooth roll out of one or more vaccines. 

And it's a very good point about not every vaccine will be effective.

In fact even the routine influenza vaccine with the best efficiacy under lab conditions, and provided the best storage / transport conditions, will only innoculate about 80% of healthy individuals with no underlying health conditions.

The effectiveness of influenza vaccines out in field and given to the general population, with non-optimal delivery and storage conditions, and a much wider range of heath conditions, will probably be much lower. 

Anyway, the general population  of S'pore will mostly likely be need to wait until mid to end 2022 at the earliest. 

[therock]

https://www.straitstimes.com/singapore/temasek-ceo-on-its-investment-in-developing-covid-19-vaccine

 

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SINGAPORE - Temasek Foundation has invested in the effort to develop a Covid-19 vaccine, said Temasek International executive director and chief executive officer Dilhan Pillay Sandrasegara on Tuesday (Nov 3).

He said this in response to a question on Temasek's role in helping to procure and distribute the vaccine, during a discussion at the Temasek Trust Conversation.

Temasek Trust is the philanthropic arm of Singapore investment firm Temasek.

Mr Pillay said the foundation had invested in an entity considered to be a leader in the quest for developing an effective vaccine, but added that the responsibility for ensuring sufficient vaccines are available is that of the Government.

The foundation will provide whatever help it can through its network and relationships as it is a collaborative effort, he added.

Amid the pandemic, Temasek has supported its foundation and partners in diagnosis, containment and contact tracing, treatment, protection and prevention, and enablement, which entails the donation of key supplies such as masks, test kits and ventilators to more than 40 countries.

Reports have also said that Temasek is among the investors who have injected US$250 million (S$340 million) through private placement in German biotech firm BioNTech, which is developing a Covid-19 vaccine.

 

[therock]

https://www.straitstimes.com/world/europe/pfizer-says-covid-19-vaccine-90-per-cent-effective-in-phase-3-trial

 

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PARIS (AFP, BLOOMBERG) - A vaccine jointly developed by Pfizer and BioNTech was 90 per cent effective in preventing Covid-19 infections in ongoing Phase 3 trials, the companies announced Monday (Nov 9).

Protection in patients was achieved seven days after the second of two doses, and 28 days after the first, according to preliminary findings.

"The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent Covid-19," Pfizer chairman and CEO Albert Bourla said in a statement.

"We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.

"We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most," Mr Bourla added.

 

[therock]

https://www.straitstimes.com/singapore/health/late-stage-covid-19-vaccine-trial-could-start-in-singapore-before-end-2020

 

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SINGAPORE - The final phase of the clinical trial for the Covid-19 vaccine that was co-developed by Singapore scientists is likely to start here before the end of this year.

Associate Professor Jenny Low, deputy clinical and scientific director at the SingHealth Investigational Medicine unit administering the trial told The Straits Times: "We are currently in phase two of the clinical trial and we expect the recruitment and dosing to be completed by November. Phase three will begin hopefully by the end of December."

The clinical trial process, which involves testing an experimental drug or vaccine on people, typically has three phases.

The first two phases are known as early-phase clinical trials, and they are mainly carried out among smaller groups of up to hundreds of volunteers to test the safety and efficacy of a vaccine.

During these stages, researchers look out for dangerous side effects and analyse patient samples to see how the human immune system is responding to the vaccine.

They also seek to determine how many doses are needed to incite the desired immune response.

Phase three trials are much larger in scope than the earlier ones, usually involving thousands to tens of thousands of people. These are often held across multiple jurisdictions or countries.

The aim of these trials is to see if the vaccine can confer protection from infection. To determine this, some of the volunteers just receive a placebo.

In June, the United States Food and Drug Administration said it expects that a Covid-19 vaccine would prevent disease or decrease its severity in at least 50 per cent of those vaccinated.

 

[therock]

https://www.straitstimes.com/world/europe/who-says-covid-19-vaccine-could-help-fundamentally-change-pandemics-arc

 

Huat ah... stock market in a frenzy..

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GENEVA (REUTERS) - A Covid-19 vaccine may be rolled out by March 2021 to the most vulnerable, which along with other advances could fundamentally change the course of the pandemic, a senior World Health Organisation (WHO) official said on Monday (Nov 9).

Bruce Aylward told the WHO's annual ministerial assembly that interim results from Pfizer Inc's late-stage vaccine trial were "very positive".

"There is still much work to be done, this is just interim results...but some very positive results coming today which should hold great promise hopefully for the entire world as we move forward," Aylward told the 194-member state forum.

"By March as a result of the extraordinary work happening globally we could be in a position to fundamentally change the direction and the dynamic of this crisis," he added.

Pfizer said its experimental Covid-19 vaccine was more than 90% effective, raising hope as the pandemic accelerates with over 50 million cases and 1.2 million deaths.

WHO Director-General Tedros Adhanom Ghebreyesus also welcomed the "encouraging vaccine news" in a tweet.

 

[therock]

[therock]

https://www.straitstimes.com/singapore/health/who-should-be-first-to-get-access-to-vaccine

 

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Q: Should Singapore go with the first vaccines available or wait for one that might be more effective or safer?

Professor Ooi Eng Eong of Duke-NUS Medical School, who is the principal investigator for one of the 48 Covid-19 vaccine candidates currently in human trials around the world, said the decision will depend on how high the risk of infection is.

If the risk is high, it makes sense to take whatever is available.

But he added that waiting a few months will not change much of the information available. "Early results would all be showing short-term protection against Covid-19. There would not be sufficient data to know which would offer the best long-term protection against Covid-19," he explained.

Professor Dale Fisher, a senior infectious diseases consultant at the National University Hospital (NUH), said taking whatever vaccine is available is important to "prevent spread, prevent disease and hospitals getting overwhelmed, and to prevent deaths".

However, if these are not priorities, then countries can afford to wait to see if there are "yet unidentified adverse reactions" and how long the vaccine is effective for.

He added that it is still unclear how the vaccines will affect the elderly, those who are immune suppressed or suffer from severe illness.

Associate Professor Hsu Li Yang, an infectious diseases expert at the NUS Saw Swee Hock School of Public Health, said that before vaccines become commercially available, the results of their licensing trials will already be public so "it will be reasonably clear how effective and safe they are compared to one another".

He added: "If the first vaccine is effective and safe, and the others in the pipeline are similar, then there is little benefit to holding out other than waiting to see if there is a significant price difference."

MORE ON THIS TOPIC

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Q: Is a person protected immediately after getting vaccinated? Does protection kick in after the first dose of a two-dose vaccine?

Many of the vaccines require two doses, given about a month apart. Prof Ooi said most clinical trials of Covid-19 vaccines start to measure efficacy two weeks after the full dose has been given.

Prof Fisher said for vaccines that manufacturers say require two doses, it will take two doses to provide effective protection.

He said Pfizer measured efficacy 28 days after the second vaccine dose. He added that if the second dose is not taken close to the 21 to 28 days stipulated, "then the first dose will be wasted".

Prof Hsu said while the first dose will give some protection, "missing out the second dose for a long period of time may negate the booster effect" which is important to achieve the full protection of the vaccine.

Q: Is there any advantage in a population getting a range of vaccines, rather than just using one for the whole country?

Given the huge demand for vaccines, countries may not have much choice about which and how many vaccines they can get.

Prof Ooi said the decision about which vaccines to use should be based on the safety and efficacy data from their phase three clinical trials. However, it might not make sense to compare across trials as their designs may be so different as to make this possible.

Prof Fisher said there is no advantage in using several types of vaccines unless they respond differently in different groups.

For example, some vaccines might be more effective for older or sick people, others might have more adverse reactions for them but work well in healthy people.

The main advantage of using different Covid-19 vaccines, said Prof Hsu, "is that there will be multiple supply lines so we can obtain a greater number of vaccine doses for the population".

MORE ON THIS TOPIC

Who are the candidates in the Covid-19 vaccine race?

Late-stage Covid-19 vaccine trial could start in Singapore before end-2020

Q: How many different types of vaccines will likely be available by next year?

Prof Fisher, who chairs the World Health Organisation's Global Outbreak Alert and Response Network, said there are more than 200 vaccine candidates, of which 48 are in human trials. There are already 11 in the final phase three clinical trials and some of these should become available.

But he added: "This doesn't mean all vaccines will be acceptable. Indeed many won't be adequately effective or safe."

Prof Hsu said he expects at least four to five vaccines by next year, with some becoming available within months of each other.

Q: How long will the protection from the vaccines last? Will it be like the influenza vaccine, which needs to be taken annually?

It is too early to know. However, all the vaccine companies will be carrying out post-marketing surveillance which will be able to tell if booster vaccinations will be needed, and if so, when they should be given.

Prof Hsu said: "The duration of immunity after natural infection remains unknown at this point, and vaccines do not generally provide longer-lasting protection compared to natural infection."

Q: What does it mean when a vaccine is 90 per cent effective?

It means that among people taking part in a clinical trial, those who had received the vaccine were only one-tenth as likely to contact Covid-19, compared with those on placebo.

Associate Professor Alex Cook, vice dean of research at the NUS Saw Swee Hock School of Public Health said not enough is known about those who did get infected.

It may have been possible that they were infected before the vaccine took effect. All that tells us, he said, is that someone who has been vaccinated "probably" will not get Covid-19.

Prof Fisher explained that in the Pfizer trial, of the 22,000 people who received vaccine, only eight were infected. Of 22,000 who were given placebo 86 were infected.

"This is why we should watch this group of 44,000 people to see what happens to more people over time," he said.

MORE ON THIS TOPIC

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Q: Once someone is vaccinated, would it serve as a passport to go about without a mask or social distancing?

Not in the early stages, said Prof Cook, but "when sufficient people are being vaccinated to reach herd immunity, then we could in principle make safe distancing optional".

Prof Hsu said people who have been vaccinated would not know if they form the 90 per cent who are protected or the 10 per cent who are not, unless they undergo testing to see if they have developed an immune response.

Prof Fisher said it would be difficult to personalise rules.

Q: What proportion of the population needs to be vaccinated for herd immunity to kick in?

That really depends on what the vaccine does, said Prof Ooi.

The primary goal now is for vaccines to protect against the disease, which means a person may get infected but not get sick. But this person might still pass the virus on to others.

It is only if the vaccine protects against infection that herd immunity can build up, since that would break the chain of transmission.

Prof Cook added that with a vaccine that is 90 per cent effective, about 60 per cent of the population needs to be vaccinated to confer herd immunity.

Prof Hsu added: "This doesn't mean that there will be no more Covid-19 cases. Just that outbreaks will be smaller and will naturally burn out each time they occur."

MORE ON THIS TOPIC

Parliament: Vulnerable people, those likelier to be exposed to Covid-19 will get vaccinated first in Singapore

Coronavirus: Why Singapore has not adopted herd immunity strategy to fight virus

Q: Who should be given priority for the vaccines?

Singapore has set up a 14-member committee to look into this but some countries have already published their priority list.

In Britain, it will start with people aged 80 years and older, as well as health can social care workers. The next group are those 65 years and older, then younger high-risk individuals.

Family doctors will drive the immunisation exercise there, and will have to prioritise their other clinical activities to cope with the estimated 975 vaccinations per week needed at each location.

The European Union is prioritising people at risk and essential workers, as well as concentrating first on geographical locations with high incidence of infection.

Canada will be vaccinating the elderly, those with high-risk medical conditions, as well as people most likely to transmit the disease to the susceptible groups. These include healthcare workers and caregivers in longterm care facilities.

Also on Canada's priority list are people needed to maintain "essential services for the functioning of society" such as firefighters and grocery store staff.

Australia said priority groups include the elderly, aged-care and health workers, as well as other workers who are critical to the functioning of society.

Prof Cook said Singapore has a compact with healthcare workers.

"They put themselves in harm's way by working on the frontlines, and we owe them the protection to keep themselves well, as well as to avoid endangering their patients. This is a social debt we owe them regardless of their citizenship," he added.

He said given the stark differences in survival rates between older and younger people infected, the elderly should also be given high priority.

Prof Fisher said offering vaccines to healthcare workers and travellers can be justified. Given that there are about 100,000 people in healthcare, including the 58,000 doctors and nurses, there may be a need to risk stratify.

He added: "In Singapore our deaths have been in older people so I think we should focus there, or on nursing home workers."

Aside from those groups, Prof Fisher added: "Indeed our biggest threat remains migrant worker outbreaks and that as a strategy could well be justified."

Q: Should the Covid-19 vaccine be voluntary or compulsory?

It should be voluntary, said the experts, especially since there will not be enough for everyone at the beginning.

But Prof Cook added: "The exceptions are when you put others at acute risk by declining vaccination.

"For instance, a frontline healthcare worker who refuses the vaccine is potentially putting her or his patients at risk, and it's questionable whether that is ethically acceptable."

 

[mersaylee]

Maciam 

You mati I mati everybody mati 

You live I live everybody live

Somebody $uat 

[CremornePt]

"Moderna says its vaccine is 94.5% effective in preventing COVID-19"...

https://www.channelnewsasia.com/news/world/moderna-vaccine-effective-covid-19-prevention-13569860

 

[StreetFight3r]

https://edition.cnn.com/2020/11/18/health/pfizer-coronavirus-vaccine-safety/index.html

A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday.

The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said.

The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up.

"Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%," Pfizer and its German partner BioNTech said in a joint statement.

"There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group." BNT162b2 is the experimental name for the vaccine.

An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said.

"The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2," the companies said. Older adults tended to have fewer adverse events and those they had were milder.

Pfizer will seek EUA 'within days'

Pfizer said it will seek US Food and Drug Administration emergency use authorization "within days."

"These data also will be submitted to other regulatory agencies around the world," Pfizer said. They plan to publish the data in a peer-reviewed scientific journal, as well.

"The rapid protection this vaccine provides -- combined with its tolerability profile in all age groups studied so far -- should help make this vaccine an important tool to address the current pandemic," said Dr. Ugur Sahin, CEO and co-founder of BioNTech.

Pfizer said on November 9 that interim data provided initial evidence the vaccine had an efficacy of more than 90%. That data was based on the first 94 cases of coronavirus infection among volunteers. The company said at the time it would need to count more cases of infection in the trial before it could consider the Phase 3 part of the trial finished and seek FDA authorization.

The Phase 3 clinical trial of the vaccine began on July 27. Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said it wanted at least two months of safety tracking on volunteers after they got their second shots.

The companies also said they have tried to recruit a diverse pool of volunteers, to match more closely the groups most severely affected by the pandemic. "Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age," Pfizer said.

The 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years.

[Heartlander]

Wah really got 95%, the bar is really getting higher and higher.

[racerbum]

How have you guys been coping? What have you been busy with?

There's a claim that the vaccine will be available this 2021. What are your thoughts about this? Are you planning to have it?

[therock]

Challenges post vaccine:

Right now, we have a few front runners, but it won't change how we live for the next 6-12 months IMO...

https://www.nbcnews.com/news/world/creating-covid-19-vaccine-only-first-step-reaching-world-next-n1248761

[therock]

The Oxford vaccine is a very good thing... something Singaporeans will like:

Cheap and good.

https://www.channelnewsasia.com/news/commentary/coronavirus-covid-19-vaccine-oxford-astrazeneca-pfizer-moderna-13628378

 

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SOUTHAMPTON, England: In the long dark tunnel that has been 2020, November stands out as the month that light appeared. Some might see it as a bright light, others as a faint light – but it is unmistakably a light.

On Nov 9, Pfizer announced the interim results of its candidate vaccine, showing it to be “more than 90 per cent effective” in preventing symptomatic COVID-19 in late-stage human trials. The news was greeted with joy.

A couple of days later, the Russian Direct Investment Fund announced that the candidate vaccine they are funding – dubbed Sputnik V – showed 92 per cent efficacy in late-stage trials.

Not to be outdone, Moderna then announced that its candidate vaccine showed 94.5 per cent efficacy.

READ: Pfizer-BioNTech COVID-19 vaccine deliveries could start 'before Christmas'

The latest COVID-19 vaccine announcement comes from Oxford University. And, as with all of the above announcements, it came via press release.

Its vaccine candidate, developed in partnership with AstraZeneca, showed an overall effectiveness of 70.4 per cent. In case that sounds disappointing, bear in mind that these are interim results and the figures might change.

Also, the Oxford vaccine was given to one group of volunteers as two standard doses, which showed 62 per cent effectiveness, and another group of volunteers as a smaller dose followed by a standard second dose. This raised effectiveness to 90 per cent.

READ: Commentary: A COVID-19 vaccine in Singapore? Here's what has to happen first

LISTEN: The COVID-19 vaccine will be the biggest product launch in history. Can we pull it off?

It’s not immediately clear why this is the case. Professor Andrew Pollard, one of the lead researchers on the project, described the results as “intriguing”.

He also highlighted that the use of lower doses means that there would be more vaccine doses available.

 

[therock]

https://www.channelnewsasia.com/news/commentary/vaccine-pfizer-moderna-work-treat-covid-19-covax-effective-13591734?cid=h3_referral_inarticlelinks_24082018_cna

 

This part is very important:

 

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HOW WILL VACCINES WORK?

The scientific issues are well-recognised and will take time to unpack. At present we do not know how well the vaccine works in specific groups of people. 

This is important, because we know that the elderly and those with underlying medical conditions are at higher risk of severe illness, but vaccines typically work less well in these groups. 

We also need to have a better understanding of how these, and other COVID-19 vaccines being developed, actually work from an epidemiological perspective. 

For example, if a vaccine stops infected people from getting COVID-19 symptoms, but does not actually prevent them from being infected in the first place, this means that vaccinated individuals could still pass on infection to others.

 

If this is the case, the vaccine will help to prevent severe illnesses and reduce strain on healthcare systems, but will not be sufficient by itself to get rid of the virus from the population. 

Finally, we need to know how long these vaccines provide protection for and ensure that they do not result in serious and unacceptable side-effects in the long-term. This will require careful studies in vaccinated populations over several months and years. 

READ: Commentary: We can't give up on developing other COVID-19 vaccine candidates now

What we learn from these studies will be crucial for informing vaccination strategies in the coming years to maximise the benefit from these vaccines. 

For example, it will tell us whether a single course of vaccination is sufficient to provide long-term protection, or whether repeated vaccinations are needed at regular intervals. 

It will also give us valuable information about what fraction of the population needs to be vaccinated in order to reach the crucial herd immunity threshold - the point at which enough people are protected to bring epidemics under control and prevent future resurgences.  

 

[therock]

https://www.gavi.org/vaccineswork/there-are-four-types-covid-19-vaccines-heres-how-they-work

 

How they work...

[inlinesix]

This is nerdy article

SARS-CoV-2 vaccines in development

https://www.nature.com/articles/s41586-020-2798-3

Edited November 27, 2020 by inlinesix