South African variant can 'break through' Pfizer vaccine, Israeli study says

JERUSALEM - The coronavirus variant discovered in South Africa can "break through" Pfizer/BioNTech's COVID-19 vaccine to some extent, a real-world data study in Israel found, though its prevalence in the country is low and the research has not been peer reviewed.

The study, released on Saturday, compared almost 400 people who had tested positive for COVID-19, 14 days or more after they received one or two doses of the vaccine, against the same number of unvaccinated patients with the disease. It matched age and gender, among other characteristics.

The South African variant, B.1.351, was found to make up about 1% of all the COVID-19 cases across all the people studied, according to the study by Tel Aviv University and Israel's largest healthcare provider, Clalit.

But among patients who had received two doses of the vaccine, the variant's prevalence rate was eight times higher than those unvaccinated - 5.4% versus 0.7%.

This suggests the vaccine is less effective against the South African variant, compared with the original coronavirus and a variant first identified in Britain that has come to comprise nearly all COVID-19 cases in Israel, the researchers said.

"We found a disproportionately higher rate of the South African variant among people vaccinated with a second dose, compared to the unvaccinated group. This means that the South African variant is able, to some extent, to break through the vaccine's protection," said Tel Aviv University's Adi Stern.

The researchers cautioned, though, that the study only had a small sample size of people infected with the South African variant because of its rarity in Israel.

They also said the research was not intended to deduce overall vaccine effectiveness against any variant, since it only looked at people who had already tested positive for COVID-19, not at overall infection rates.

Pfizer and BioNTech could not be immediately reached for comment outside business hours.

The companies said on April 1 that their vaccine was around 91% effective at preventing COVID-19, citing updated trial data that included participants inoculated for up to six months.

In respect to the South African variant, they said that among a group of 800 study volunteers in South Africa, where B.1.351 is widespread, there were nine cases of COVID-19, all of which occurred among participants who got the placebo. Of those nine cases, six were among individuals infected with the South African variant.

Some previous studies have indicated that the Pfizer/BioNTech shot was less potent against the B.1.351 variant than against other variants of the coronavirus, but still offered a robust defense.

While the results of the study may cause concern, the low prevalence of the South African strain was encouraging, according to Stern.

"Even if the South African variant does break through the vaccine's protection, it has not spread widely through the population," said Stern, adding that the British variant may be "blocking" the spread of the South African strain.

Almost 53% of Israel's 9.3 million population has received both Pfizer doses. Israel has largely reopened its economy in recent weeks while the pandemic appears to be receding, with infection rates, severe illness and hospitalizations dropping sharply. About a third of Israelis are below the age of 16, which means they are still not eligible for the shot. 

-reuters-

Pfizer says South African variant could significantly reduce vaccine protection

A laboratory study suggests that the South African variant of the coronavirus may reduce antibody protection from the Pfizer Inc/BioNTech SE vaccine by two-thirds, and it is not clear if the shot will be effective against the mutation, the companies said on Wednesday.

The study found the vaccine was still able to neutralize the virus and there is not yet evidence from trials in people that the variant reduces vaccine protection, the companies said.

Still, they are making investments and talking to regulators about developing an updated version of their mRNA vaccine or a booster shot, if needed.

For the study, scientists from the companies and the University of Texas Medical Branch (UTMB) developed an engineered virus that contained the same mutations carried on the spike portion of the highly contagious coronavirus variant first discovered in South Africa, known as B.1.351. The spike, used by the virus to enter human cells, is the primary target of many COVID-19 vaccines.

Researchers tested the engineered virus against blood taken from people who had been given the vaccine, and found a two- thirds reduction in the level of neutralizing antibodies compared with its effect on the most common version of the virus prevalent in U.S. trials.

Their findings were published in the New England Journal of Medicine (NEJM).

Because there is no established benchmark yet to determine what level of antibodies are needed to protect against the virus, it is unclear whether that two-thirds reduction will render the vaccine ineffective against the variant spreading around the world.

However, UTMB professor and study co-author Pei-Yong Shi said he believes the Pfizer vaccine will likely be protective against the variant.

"We don't know what the minimum neutralizing number is. We don't have that cutoff line," he said, adding that he suspects the immune response observed is likely to be significantly above where it needs to be to provide protection.

That is because in clinical trials, both the Pfizer/BioNTech vaccine and a similar shot from Moderna Inc conferred some protection after a single dose with an antibody response lower than the reduced levels caused by the South African variant in the laboratory study.

Even if the concerning variant significantly reduces effectiveness, the vaccine should still help protect against severe disease and death, he noted. Health experts have said that is the most important factor in keeping stretched healthcare systems from becoming overwhelmed.

More work is needed to understand whether the vaccine works against the South African variant, Shi said, including clinical trials and the development of correlates of protection - the benchmarks to determine what antibody levels are protective.

Pfizer and BioNTech said they were doing similar lab work to understand whether their vaccine is effective against another variant first found in Brazil.

Moderna published a correspondence in NEJM on Wednesday with similar data previously disclosed elsewhere that showed a sixfold drop antibody levels versus the South African variant.

Moderna also said the actual efficacy of its vaccine against the South African variant is yet to be determined. The company has previously said it believes the vaccine will work against the variant. 

-reuters-

Australia aims to complete review of Pfizer's COVID-19 vaccine by January

SYDNEY - Australia's pharmaceutical regulator said on Thursday it is on course to review Pfizer's COVID-19 vaccine by January 2021, with the country sticking to a March timetable to start vaccinations.

Britain on Wednesday approved the use of the Pfizer vaccine, jumping ahead of the rest of the world in the race to begin the most crucial mass inoculation program in history.

But John Skerritt, the head of Australia's Therapeutic Goods Administration (TGA) said it would likely complete its review by "late January" and has told staff not to plan a holiday to get the work done.

"My staff have been told to put away their swimsuits and towels and to work as quickly as we can but also in significant depth," Skerritt told reporters in Canberra.

Pfizer's is one of the four COVID-19 vaccines Australia has agreed to buy, including from Novavax, AstraZeneca and CSL Ltd, should trials prove successful.

Health Minister Greg Hunt said the January timetable does not accelerate plans to begin vaccinations.

"We are on track for first vaccinations beginning with our health workers and our aged care residents subject to approvals in March," Hunt told reporters in Canberra.

Treasurer Josh Frydenberg said getting a vaccine out by then would boost the country's economy by A$34 billion ($25 billion) compared with earlier assumptions of 2022.

Australia is in the fortunate position of being able to allow regulators time to complete checks without the pressure of mounting cases of COVID-19.

Its tally of more than 27,800 infections is far fewer than many other developed countries, and until Wednesday gone nearly three weeks without any local transmission of COVID-19.

The streak was broken when Australia's most populous state said a worker at a hotel, where overseas travelers are quarantined for two weeks, tested positive for COVID-19.

-reuters-

Moderna vaccine results 'stunningly impressive,' Fauci tells AFP

WASHINGTON - The United States' top infectious disease official on Monday hailed early results from Moderna's COVID-19 vaccine as "stunningly impressive," calling the result a validation for experimental mRNA technology that some had doubted.

"I had said, and I must admit, that I would have been satisfied with 70, or at the most 75 percent efficacy," Anthony Fauci told AFP.

"The idea that we have a 94.5 percent effective vaccine is stunningly impressive. It is really a spectacular result that I don't think anybody had anticipated would be this good."

The physician-scientist leads the National Institutes of Health's National Institutes of Allergies and Infectious Diseases (NIAID), which began co-developing the vaccine in January, shortly after Chinese authorities disclosed the genetic sequence of the new coronavirus.

The vaccine is based on a new technology that uses a synthetic version of a molecule called "messenger RNA" to hack into human cells, and effectively turn them into vaccine-making factories.

"There were many people who had reservations about using something that had not been tried and true over the years, in fact some people even criticized us for that."

On Monday, Moderna and the NIH announced their preliminary results based on 95 of the 30,000 volunteers they have recruited who fell ill with COVID-19.

Of the 95, 90 had been in the trial's placebo group, and 5 in the group that received the drug, called mRNA-1273, translating to an efficacy rate of 94.5 percent.

Asked whether it was too early to say if the mRNA platform had now been proven, Fauci, who is usually known for his cautious statements, said the jury was in.

"Oh no! I think when you have 2 vaccines, like this, that have proven to be greater than 90 percent effective, I think that mRNA is here, it's established itself, it doesn't need to prove anything anymore.

"The data speak for themself, it isn't me, it isn't my opinion, look at the data."

While Moderna has basked in the spotlight, Fauci was keen to highlight the critical work of the NIH, which he said was responsible for developing the correct "conformation" or spatial arrangement of the virus' spike protein, which the vaccine makes inside the body to elicit an immune response.

Looking forward, he said he was worried about anti-vaccine sentiment in the United States, the hardest-hit country in the world. 

"There's a long way to go -- don't forget, you've got to get this distributed, you've got to get most of the people to get vaccinated.

"There's a lot of anti-vaccine sentiment in this country. You've got to overcome that and convince people to get vaccinated because a vaccine with a high degree of efficacy is of no use if nobody gets vaccinated." 

Agence France-Presse

BioNTech and Pfizer's COVID-19 vaccine shows potential in human trial

FRANKFURT - A COVID-19 vaccine developed by German biotech firm BioNTech and US pharmaceutical giant Pfizer has shown potential and was found to be well tolerated in early-stage human trials, the companies said Wednesday.

The drug is one of 17 being tested on humans in a frantic global race to find a vaccine the world is counting on to end a pandemic that has infected 10.5 million people and killed more than half a million so far.

The potential treatment is the fourth early-stage COVID-19 drug to show promise in human testing, along with projects involving Moderna, CanSino Biologics and Inovio Pharmaceuticals.

BioNTech's shares were up 4.6 percent, after rising as much as 19 percent to reach their highest in more than 3 months.

Pfizer stock also gained, rising 4.4 percent to $34.13. In turn, shares in some rival vaccine developers, such as Moderna and Novavax Inc dropped.

BioNTech said testing of 2 dosages of its BNT162b1 drug on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.

It said the higher of the 2 doses - both administered via 2 injections within 3 weeks of one another - was followed by a short fever in 3 out of 4 participants after the second shot.

A third dosage, tested at a higher concentration in a separate group, was not repeated after the first shot because of injection pain.

"These first trial results show that the vaccine yields immune activity and causes a strong immune response," said BioNTech's co-founder and Chief Executive Officer Ugur Sahin.

He said larger trials were being prepared to show whether this translates into protection against a real infection.

"While more work needs to be done, we believe the benefits appear to outweigh the risks so far, especially when considering the disease the vaccine is trying to prevent," Mizuho Securities analyst Divan Vamil said in a note.

PEER REVIEW

No COVID-19 vaccine has yet been approved for commercial use. A Massachusetts Institute of Technology analysis last year found that about 1 in 3 vaccines in the first stage of testing later gains approval.

BioNTech, which listed on the US Nasdaq in October, said the data demonstrated that BNT162b1 could be administered in a dose that was well tolerated with only temporary side effects.

Early-stage human trials of vaccines are designed to measure certain antibodies and other immune markers in the blood as an indicator of the body's readiness to fight an infection that then requires further validation.

The pharmaceutical industry is eager to launch larger follow-up trials to see how vaccinated participants react to real infections over longer periods.

BioNTech and Pfizer will now pick the most promising of 4 experimental vaccines for a trial involving up to 30,000 healthy participants, which is likely to begin in the United States and Europe in late July, if it gets the regulatory green light.

If it eventually gets marketing approval, the companies are gearing up to make up to 100 million doses by the end of 2020 and another 1.2 billion doses by the end of 2021 at sites in Germany and the United States.

Results from early-stage testing of BioNTech's 3 other potential vaccines have yet to be published.

The manuscript with the preliminary data from the clinical trials, which were launched in April and May, is under peer review for publication in a scientific journal, BioNTech said.

Singapore's state investment fund Temasek and other investors said on Monday there were investing $250 million into BioNTech for a 1.1 percent stake in company.

The Mainz-based company is using the so-called messenger RNA approach, like unlisted domestic rival CureVac and Moderna. Translate Bio and its partner Sanofi are also working on a messenger RNA vaccine for COVID-19.

Biotech investors Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005, are major shareholders of BioNTech.

-reuters-