The World Health Organization (WHO) has suspended its approval process for the Russian vaccine against the Sputnik V coronavirus, pending further inspection of at least one Russian factory making the vaccine.

Speaking during a press conference of the Pan American Health Organization, a regional arm of the WHO, Deputy Director Jarbas Barbosa said Russia’s emergency clearance request was suspended after a number of manufacturing violations were discovered during a WHO inspection in Russia in May.

Sputnik V’s Emergency Use List (EUL) process was put on hold because during an inspection of one of the factories where the vaccine is being made, they discovered that the factory was not in operation. accord with best manufacturing practices, ”Barbosa said Wednesday.

WHO before reported he had found multiple violations and had concerns about the “implementation of adequate measures to mitigate the risk of cross-contamination” at a Pharmstandard factory in the Russian city of Ufa.

Following the publication of the WHO findings, the factory said it had already addressed their concerns and inspectors had not questioned the safety or effectiveness of the vaccine. But independent scientists and industry figures told the Moscow Times the manufacturing violations could compromise the quality of the vaccine.

The WHO said on Wednesday it was still awaiting an update from Pharmstandard and suggested that further inspections of the facilities would be needed before the agency grants approval to Sputnik V.

“The grower needs to take this into consideration, make the necessary changes and be ready for further inspections. WHO is waiting for the manufacturer to send information indicating that their factory is in compliance with the code, ”said Barbosa.

Russia submitted its requests for approval to both the WHO and the European Medicines Agency (EMA) in February, following the publication of research in leading medical journal The Lancet that showed that the vaccine was 91.6% effective.

But the offer encountered multiple problems and was beset by delays.

EMA and WHO said last week that they are still waiting a “full data set” from the developers of Sputnik V. The EMA declined to say what kind of information was missing. The body is Vaccine strategy manager Marco Cavaleri said the timing of final approval was “uncertain” amid the lockdowns.

Getting approval from either organization would be a major victory for Russia, which has launched an aggressive vaccine diplomacy campaign and sold millions of doses to dozens of countries. It would also pave the way for eventual mutual recognition of vaccines, simplifying post-pandemic travel for Russians vaccinated with Sputnik V.

• Virgin Galactic has rescheduled a commercial research test flight for a potential manufacturing defect.
• The possible flaw was unrelated to the FAA’s investigation into its rocket plane, the company said.
• Virgin has postponed its space mission with the Italian Air Force no earlier than mid-October.

Billionaire Richard Branson’s Virgin Galactic said on Friday that its first commercial research mission with the Italian Air Force would be delayed due to a possible manufacturing defect.

The spaceflight company said during groundwork, a third-party vendor reported a potential defect in a component of the flight control system provided.

“At this point, it is not yet clear whether the defect is present in the company’s vehicles and what repair work, if any, might be needed,” Virgin Galactic said in a statement.

The company said it is performing a supplier inspection, which is part of Virgin Galactic’s standard safety procedures.

The mission, dubbed “Unity 23”, was initially scheduled for September or early October. It has now been pushed back to mid-October at the earliest.

Virgin said the space flight will carry three paid crew members from the Italian Air Force and the National Research Council to conduct research on current and future space flight systems and technologies.

The Federal Aviation Authority was investigating the rocket that Branson took to edge of space on July 11 – called Unity 22 – claiming it had gone out of its clearance zone when it returned. Virgin Galactic shares fell 7% after the FAA announced earlier this month.

The FAA investigation was unrelated to the now delayed space mission, Virgin said.

“Our test flight processes and procedures are rigorous and structured to identify and resolve these types of issues,” Michael Colglazier, CEO of Virgin Galactic, said in a statement. “We are looking forward to getting back to flight soon.”

Recently, the Biden administration called on US automakers to pledge that 40% of their manufacturing output will be electric vehicles (EVs) by 2030. Auto production is deeply rooted in the history of the United States. American manufacturing and innovation. The shift to electric vehicle production will require careful planning and years of time invested to create affordable and reliable electric alternatives.

As governments around the world announce plans to ban gasoline cars, let’s take a look at how engineers are pivoting and evolving their approach to building affordable and reliable electric vehicles.

Construction competition

Auto industry experts should have seen this decision coming from the Biden administration. The wider adoption of electric vehicles has been an inevitable change in the industry that has kept auto CEOs from sleeping at night since Tesla’s rise. Even as governments around the world put more pressure on automakers to effect the change, these companies knew they would need to start the change.

Competition in the electric vehicle market is intensifying – besides Tesla’s all-electric option, hybrid cars have also proven to be very popular. Toyota is a prime example of a successful hybrid option with its popular Prius. Start-ups will also play a role, but success for new entrants means getting to market quickly – it’s a difficult task when building a whole new product can take five to 10 years.

Arguably, a more difficult challenge for traditional automakers like GM and Ford will be figuring out how to bring their own electric vehicles to market. They need to scale as quickly as possible to a mass production scale with the least manpower and design changes given existing infrastructure built for gasoline models. The question will be: is this enough to win over the consumer? With so many new options available, electric vehicles must have unique value.

Although these companies do not bear as large a capital charge as starting from scratch, they must master the process of modernizing factories, redesigning production lines and retraining their workforce. Understanding how to make electric vehicles commercially viable is always a challenge, especially for incumbent automakers.

Gas-fired automakers also face the challenge of creating unique next-generation EV products, rather than simply integrating EV engines into their existing models – the innovation push is not limited to new entrants to this automotive space. .

First or better?

It is always a question for the leaders of any competitive sector and it is the case in the market of electric vehicles for the companies which seek the best position in the market for their electric offer. Product managers face tough choices in deciding which features can be removed to get to market quickly, and then potentially rebuild and expand as market penetration sets in.

The Ford Mustang, for example, has stepped up delivery of its EV SUV to hit the market as soon as possible while filling a market gap that does not currently exist, with electric vehicles primarily designed as sedans. At the moment, the choice of Mustang seems to be the right one, with Mustang Mach-E SUVs occupying the second market share position behind Tesla.

With the need for vital research and competitor intelligence, the tedious workforce reviews for traditional automakers, and the incredibly complex systems that product managers must quickly figure out, the future is complicated as he industry is turning towards electricity. It is much easier said than done.

Having the right planning tools and the right data will be essential for product managers, but the scariest part is that today’s tools are still far from where they should be in 2021. Today, product managers are still looking for on the Internet information about other competitors. They still use primitive tools like spreadsheets and PowerPoints to communicate plans to mass production operations. Tools and data must enable product teams to be more agile and respond quickly to changing market needs.

For reporting and analysis, the market still lacks a central place where product managers can follow strategy, decision-making and changes to production plans of complex vehicles, and integrate all information from different parts of the production process. Businesses need to harness the power of this data to better understand the process and speed up production time.

In the future, the analytical power of these data tools will be precise enough to actually predict the results of future products. Until such a tool exists, product managers will always be late.

By combining and aligning people, from senior executives and trend watchers to product managers, with your data-driven processes and platforms, automakers can successfully plan their products for the future. The next two to three years will be crucial for the auto industry to reach Biden’s 2030 target: start laying the foundation for successful electric vehicle adoption now.