Domestic violence on the rise amid falling incomes and rising alcohol consumption

British-Swedish pharmaceutical company AstraZeneca announced this week that their experimental coronavirus vaccine candidate is, on average, 70% effective. But since Monday’s announcement vaccine experts from around the world have questioned the methodology of the trials and transparency of the announced Phase 3 trial results.

The questions and uncertainty of the AstraZeneca vaccine trials will set back the timing for the vaccine to be authorised other parts of the world. Scientists are curious why the company has pooled results from different trials, saying that this “deviates from standard reporting on clinical trials”.

AstraZeneca announced last Monday that the participants in the UK had been given 2 different courses of the candidate vaccine.

The drugmaker, who co-developed the vaccine with the University of Oxford, didn’t explain why they used 2 different dosing regimens, or why the size of one group was significantly smaller than the other.

• In one group, 2,741 participants received a half-dose of the vaccine followed by a full dose at least 30 days later. This group was 90% protected against Covid-19.

• In the second group, 8,895 participants received a full dose followed by another full dose a month later. This group was only 62% protected.

The 2 trials, when averaged, according to AstraZeneca, gives their vaccine its reported 70% effectiveness. But epidemiologists say that the small number of people in the low dose group make it difficult to know if the effectiveness “was a statistical quirk”.

David Salisbury, from the global health program at London-based Chatham House, said another area of confusion was that the studies pooled results from the two groups to reach an average of 70% efficacy. Speaking to AP…

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses. I think many people are having trouble with that.″

Then, Mene Pangalos, head of biopharmaceuticals research and development at AstraZeneca, responded to Reuters saying that a “lab error” was the reason why some volunteers had received a smaller dose… the dose that proved to be 90% effective.

“The reason we had the half dose is serendipity, Researchers had underpredicted the dose of the vaccine by half.”

Then, the next day, University of Oxford chimed in in a statement… “dose selection for any new vaccine is a complicated area, and in exploring methods of dose selection, we discovered one gave a lower dose than expected.”

“A difference in the manufacturing process had led to the error.”

AstraZeneca say that these “manufacturing problems” have been corrected, noting that the UK regulator overseeing the trial had agreed to include “both approaches” in Phase 3.

Speaking to the Wall Street Journal on Wednesday, Menelas Pangalos said that the mistake is actually irrelevant.

“Whichever way you cut the data, even if you only believe the full-dose, full-dose data, we still have efficacy that meets the thresholds for approval with a vaccine that’s over 60% effective.”

The trial’s lead investigator at Oxford University, Professor Andrew Pollard, as part of the announcements on Monday, said that’s the issue is likely to do with the delicate balance of dosing someone just enough to trigger an immune response against the disease.

“What we’ve always tried to do with a vaccine is fool the immune system into thinking that there’s a dangerous infection there that it needs to respond to, but doing it in a very safe way.”

“So, it may be that the best way of kicking the immune system into action could be to give the body a small amount of the vaccine to begin with, and then follow up with a larger amount.”

Responding to whether he had genuine confidence that the half-dose group’s 90% success was not just a feature of a small sample size, Pollard said that result was “highly significant…even with the numbers that we have.”

Moncef Slaoui, a US-based researcher and former head of GlaxoSmithKline’s vaccines department who leads the US coronavirus vaccine program, says they were reviewing AstraZeneca’s vaccine data.

He noted that group that got the lower dose that yielded the 90% efficacy had been a younger group, with no one older than 55.

“That could potentially affect the strength of AstraZeneca’s findings, given that young people typically produce stronger immune responses to vaccines. We want it to be based on data and science.”

Natalie Dean, assistant professor of biostatistics at the University of Florida said that the AstraZeneca/Oxford University team “get a poor grade for transparency and rigour when it comes to the vaccine trial results”.

“This is not like Pfizer or Moderna where we had the protocols in advance and a pre-specified primary analysis was reported.”

AstraZeneca shares have fallen 12% since November 11.

SOURCE: Euro News | Reuters | CNN

The Thai PM, Prayut Chan-o-cha, has confirmed that Thailand will today sign a contract with Oxford University and pharmaceutical giant AstraZeneca, for the procurement of their Covid-19 vaccine. The PM says the agreement will mean Thais can access the vaccine once it goes into production. This contract is in addition to the agreement signed for the transfer of vaccine technology that will enable it to be manufactured here.

Earlier this week, the team behind the vaccine announced that it was between 70-90% effective, depending on the dosage. The discrepancy raised some questions, as it appeared the vaccine was more effective when administered first as a half-dose, followed by a full dose, rather than when 2 full doses were administered. The team now says it may carry out another global trial to determine why the lower dose appears more effective.

The PM points out that one significant advantage the vaccine has is that it can be stored at temperatures of 2 – 8 degrees Celsius, unlike those of Pfizer-BioNTech and Moderna, which need to be stored at much lower freezer temperatures (around -70 degrees Celsius, in the case of the Pfizer jab). Such a requirement could create a logistical nightmare for some countries.

The PM says the vaccine is likely to be approved and go into production in Thailand by the middle of 2021, adding that the quicker it’s available, the quicker the tourism sector and the overall economy will recover.

According to a Thai PBS World report, the PM says many other countries have signed similar deals with pharmaceutical companies, in order to guarantee access to effective vaccines for their citizens. Meanwhile, he adds that, until the vaccine is available, people should continue with hygiene measures such as mask-wearing in public spaces, hand-washing and social distancing, in order to avoid the repeat waves of the virus that other countries are having to deal with.

SOURCE: Thai PBS World

The former director general of the World Trade Organisation has issued a caution against Thailand throwing open its borders too early. Supachai Panitchpakdi says Covid-19 is still very much a threat, pointing to other countries that appear trapped in a cycle of easing restrictions, followed by renewed lockdowns. His comments come as England emerges from a national lockdown, only for many areas to find themselves subject to even tougher measures, at least until Christmas.

According to a Nation Thailand report, Supachai says the cycle of lockdown/open up/lockdown that’s being seen in many Western countries is not just damaging their economies, it’s also leading to more infections and deaths. He warns that re-opening Thailand’s borders too quickly could have long-term negative impacts for the Kingdom.

“Thailand should gradually open the country, because human resources are the most important factor. It takes about 20 to 30 years for human development, and if those people die, it will be very difficult to restore the lost human resources.”

Within Thailand there is a polarised view as to whether Thailand should be broadly re-opening its borders or not. Successive polls show that the Thai population is, generally, suspicious about re-opening too soon, especially whilst parts of the rest of the world are still trying to contain their infection rates. On the other hand Thailand’s tourism and hospitality industry has been decimated with millions unemployed.

Supachai’s comments come as the government has tentatively opened the borders to foreign tourists, albeit at a significant cost and inconvenience to those who might want to visit. There is both a long term STV, special tourist visa, and a modified general tourist visa for up to 60 days. In both cases there is currently a 14 day mandatory quarantine to be served and a number of other paperwork hurdles to overcome.

Supachai says Thailand’s economy is likely to shrink by 5 or 6% this year, a change from the previous forecast of 7 or 8%. He adds that he’s hopeful the economy and exports will recover next year, pointing out that if a quick recovery is seen in China and ASEAN nations, it will help Thai exports. He warns that an appreciating baht could threaten Thailand’s exports and that exporters will need to look at ways of increasing their competitive edge.

He has also called for a hike in interest rates, pointing out that the low rate of 0.5% is having a detrimental effect on people’s savings. Another fallout from the pandemic is an increase in household debt, with Supachai expressing concern that Thai people are getting into debt at a much younger age compared to the trend in other countries.

SOURCE: Nation Thailand