• Protein Sciences is participating in a National Institute of Allergy and Infectious Diseases grant program to develop and produce antigens for the HIV/AIDS vaccines.

• Participation in the program gives the company a vote of confidence for its technology, according to Manny Ratafia, president of Technology Management Group in New Haven, which studies the pharmaceuticals market.

• Protein Sciences has been asked by the NIAID to create a synthetic protein developed by Epimmune, a biotechnology company in San Diego.

• Manon Cox, vice president of corporate and process development at Protein Sciences, has said than many companies decline to develop AIDS vaccines for economic reasons.

• The NIAID grant program will enable companies by providing government funding.

• In the past the company has attempted to develop AIDS vaccines on its own.

• Protein Sciences was formerly know as [MicroGeneSys, Incorporated] and founded in 1983.

• It uses its proprietary baculovirus expression vector system (BEVS) technology to develop commercial human and veterinary vaccines, therapeutics and diagnostics.

• It uses a system it calls GeneXpress to enable customers to access its proprietary BEVS technology.

• On its web site at http://www.proteinsciences.com, the company say this system is "the quickest and most cost-effective link between gene discovery and clinical materials".

While a universal flu vaccine would be ideal, the world’s best hope for now might be to speed up the production of strain-specific vaccines.

The World Health Organization estimates that the world has the capacity to produce one billion to two billion doses of a vaccine against the new swine flu virus in one year. That would leave most of the world’s population dangerously unprotected if the virus, known as H1N1, leads to a pandemic.

The problem is that flu vaccine production relies on growing the virus in chicken eggs, a process that has been used for more than half a century. It can take four to six months to produce a vaccine this way.

One of the most practical ways to increase vaccine production is to add an immune stimulant, called an adjuvant, to the vaccine. That can sharply reduce the dose of vaccine needed, allowing a given amount produced to help more people.

GlaxoSmithKline says it is planning to make a vaccine against the H1N1 strain that contains an adjuvant. Novartis sells in Europe a seasonal flu vaccine containing an adjuvant. But no adjuvant for flu vaccine has been approved for use in the United States, in part out of concerns about safety.

Live-virus vaccines, like the nasal spray FluMist, also use far less viral material per dose than the inactivated viruses made by most manufacturers.

The federal government has given the vaccine industry $1.3 billion to spur a shift from growing the viruses in eggs to growing them in stainless steel tanks containing mammalian cells.

Such cell culture could shave a few weeks off the process, experts estimate, and would eliminate the need for millions of eggs on short notice. “The chickens are not laying more just because we need them suddenly,” said Dr. Andrin Oswald, the chief of Novartis’s vaccine business. Some vaccines made in cells have been approved in Europe but not in the United States.

Some entrepreneurs say that cell culture is a marginal improvement and that the government should have spent more money developing radical new technologies that could produce billions of doses in a short time.

“They’ve spent way too much money on cell culture,” said Vijay Samant, chief executive of Vical, a San Diego vaccine company. “I don’t believe in cell culture technologies because they are not fast enough. We need a paradigm shift here.”

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said cell culture was ready for manufacturing, which requires a lot of money, while the newer techniques were still in the research phase. “I don’t think it reflects a lack of appreciation of the importance of the new platforms,” he said.

In general, the new techniques do not try to grow the virus at all. Rather, they use genetic engineering to make proteins from the virus to use in the vaccine.

Protein Sciences of Meriden, Conn., for instance, makes hemagglutinin, the main viral component of vaccines, in genetically modified insect cells. It has applied for federal approval of its seasonal flu vaccine.

Novavax, of Rockville, Md., uses insect cells to make three flu proteins, which assemble into a so-called viral particle to better stimulate the immune system. The company grows its cells in disposable plastic bags for rapid deployment anywhere in the world.

VaxInnate, of Cranbury, N.J., can make its proteins in fast-growing, genetically engineered bacteria. That would allow for 400 million doses to be produced in just two weeks, said Alan Shaw, the chief executive.

Vical uses DNA corresponding to the genetic sequence of the virus as a vaccine. When the DNA enters cells in the body, those cells make viral proteins that incite the immune system. In effect, the body becomes its own vaccine factory.

But while production might be fast, regulatory processes are slow. Years are needed to demonstrate that a vaccine is safe and effective to win regulatory approval. So the authorities are likely to stick with the tried and true.

“There is a big leap of faith to say a few dozen healthy individuals have been vaccinated and that you can take these and use them in millions of people,” said Marie-Paule Kieny, director of the initiative for vaccine research at the World Health Organization.

Still, if there is a pandemic, some governments might be willing to experiment. Protein Sciences says it is in talks with Mexico, which has been hardest hit by the new flu strain, about making vaccine there.

A small biotechnology company facing possible bankruptcy and liquidation has been awarded a $35 million federal contract to develop a faster way to make vaccines for pandemic influenza.

The award of the contract to the Protein Sciences Corporation of Meriden, Conn., was announced on Tuesday by the Department of Health and Human Services. But only a day earlier, creditors filed a petition in federal bankruptcy court in Wilmington, Del., seeking to force Protein Sciences into bankruptcy and liquidation, saying they were owed $11.7 million.

Almost all of that money is owed to Emergent BioSolutions, a vaccine company in Rockville, Md., that lent Protein Sciences $10 million last year in advance of the pending acquisition of virtually all the assets of Protein Sciences by Emergent. The acquisition deal fell apart, and Emergent sued Protein Sciences and its top executives, accusing them of fraud and breach of agreements.

The series of events raises questions about whether the government is entrusting part of the nation’s influenza defense to a financially shaky or untrustworthy company. Conversely, the award of the contract could put Emergent into an uncomfortable light for trying to force into bankruptcy a company with promising vaccine technology.

Robin Robinson, director of the branch of Health and Human Services that will administer the contract, said the government had spent months doing “two very thorough financial audits” of Protein Sciences. “It was determined that they were healthy enough to go forward with development of this vaccine,” he said.

Health authorities are scrambling to come up with enough vaccine to protect the world’s population against the recently declared pandemic of swine flu, which has killed more than 230 people worldwide and sickened more than 52,000. They are worried that the death toll from the strain might rise sharply this winter.

“I can’t imagine what legitimate purpose can be served by trying to close the company,” Daniel D. Adams, the chief executive of Protein Sciences, said in an interview on Tuesday. Mr. Adams said that Emergent’s suit was without merit and that its actions were making it difficult for Protein Sciences to attract new investors.

But Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, said that bankruptcy “doesn’t destroy the product, and it doesn’t destroy the technology.” It might result in the technology’s being sold to a stronger company, like his own or others, he said. Emergent, which makes the anthrax vaccine used by the armed forces, says it has been more than patient in giving Protein Sciences a chance to pay back the loan.

Protein Sciences is one of several small companies trying to make influenza vaccines by methods that are faster than growing them in chicken eggs, the technique now generally used.

Instead of growing whole viruses, Protein Sciences produces just a protein from the virus and it does so in genetically modified insect cells.

The company, which is privately held, has already applied to the Food and Drug Administration for approval of a seasonal flu vaccine. And last week, Mr. Adams said, the company made its first 100,000 doses of a vaccine against the new swine flu.

The federal contract will help Protein Sciences develop its technology and obtain F.D.A. approval. It can be extended up to five years for a total cost of $147 million.

If the technology is proved safe and effective and is licensed by the F.D.A, the contract calls for Protein Sciences to establish domestic manufacturing capacity, to provide a finished vaccine within 12 weeks of the onset of a pandemic and to produce at least 50 million doses of a pandemic flu vaccine within six months.

Mr. Robinson of Health and Human Services said that for the current pandemic, the Protein Sciences vaccine might be used as a backup to those being supplied by larger companies.

A new type of flu vaccine won regulatory approval on Wednesday, and its manufacturer said that limited supplies are expected to be available this winter.

The vaccine, developed by a small company called Protein Sciences, is made with a process that does not require the virus to be grown in chicken eggs, as is now generally done. That means a vaccine could be ready weeks earlier in the event of a pandemic.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Dr. Karen Midthun, a senior official at the Food and Drug Administration, said in a statement announcing the agency’s approval of the product, which is called Flublok.

The approval comes during one of the more severe flu seasons in recent years, with many Americans rushing to find diminishing supplies of vaccine and spot shortages being reported.

Manon Cox, the chief executive of Protein Sciences, said the company could have about 150,000 doses ready to distribute later this flu season. That is a relatively small amount, but it could be particularly helpful for people who do not get flu shots now because they are allergic to eggs.

A spokeswoman for the F.D.A. said the timing of the approval was unrelated to the current flu season.

Most flu vaccines are made by growing the virus in chicken eggs, then inactivating or killing it, a long process.

Flublok, by contrast, consists only of a protein — hemagglutinin — from the virus. The protein is made by putting the gene for hemagglutinin into a virus that infects insect cells. Those cells, from the fall armyworm, are grown in culture and churn out the protein. Neither eggs nor the live virus are used, though viral genetic information is needed.

While new for flu, such protein-based vaccines are used to prevent some other diseases.

Protein Sciences, a privately held company in Meriden, Conn., first applied for approval nearly five years ago. It was turned down twice, in part because of the novelty of using insect cells. “Every time we were asked to do more and more studies to prove that this cell substrate was safe,” Ms. Cox said.

The company was close to bankruptcy in 2009 when it received a federal contract worth tens of millions of dollars to help develop its vaccine.

The vaccine is approved only for adults 18 to 49 years old. In a clinical trial, Flublok was about 44.6 percent effective against all influenza strains, not just the three contained in the vaccine, the F.D.A. said. As with current vaccines, Flublok will need to change each year to match the flu strains in circulation.

Health authorities and pharmaceutical companies are planning to test several new vaccines to prevent Ebola infection over the next few months, including one that is taken as a tablet, making it easier to deploy in West Africa.

The plans signify that a response to the Ebola outbreak is finally gathering steam. It is still unclear if any of these vaccines will work, however, and even if they do, they may not be ready in time to help stem the current epidemic.

Starting in January, two vaccines will be tested in large studies in the West African countries most affected by the outbreak, the World Health Organization said on Tuesday. At least three other vaccines will begin safety testing in healthy volunteers outside the outbreak zone in the first quarter of 2015.

One of those three is actually a combination of two inoculations being developed by Johnson & Johnson and Bavarian Nordic, a Danish company.

Johnson & Johnson announced early Wednesday that it was committing $200 million to the program, including making an equity investment of about $43 million in Bavarian Nordic to help pay for that company’s part in the project. It says it plans to begin safety trials in January and hopes to produce one million doses in 2015, with 250,000 available for broad application in clinical trials by May.

“Typically, you don’t make hundreds of thousands of vaccines before you know what the safety and immunogenicity is,” said Dr. Paul Stoffels, chief scientific officer of Johnson & Johnson. “This time, we will do that.”

The two most advanced vaccines in terms of development is each undergoing testing in about 250 healthy adult volunteers in the United States and other countries outside the outbreak region.

One of the vaccines was developed by the National Institutes of Health and GlaxoSmithKline. The other was initially developed by the Public Health Agency of Canada and licensed to NewLink Genetics, a company in Iowa.

[....]

“We are doing everything we can to produce as many doses as we can as quickly as we can,” said Dr. Ripley Ballou, who leads the vaccine effort for GlaxoSmithKline.

Dr. Ballou said that while Glaxo would not have enough doses to vaccinate millions of Africans against Ebola, there should be enough by sometime next year to help slow the outbreak by protecting health care workers or those close to infected people.

Dr. Kieny said that three other vaccines would be ready early next year to enter Phase 1 testing, starting with the combination from Johnson & Johnson and Bavarian Nordic.

A second is being developed by Inovio Pharmaceuticals, a small company in Plymouth Meeting, Pa. The third is from [Protein Sciences Corporation] of Meriden, Conn., which already sells a flu vaccine.

Dr. Kieny also said her organization was trying to find out more about vaccines being developed in Russia.

She did not mention the tablet vaccine, which Vaxart, a privately held company in South San Francisco, Calif., is developing.

Wouter Latour, the chief executive, said in an interview that, after recent discussions with the Food and Drug Administration, the company hoped to start a Phase 1 safety trial toward the end of the first quarter of 2015.

“This is ideal to bring to bear on the Ebola crisis,” Dr. Latour said. Not only is it not injected but it is stable at room temperature. Some of the other vaccines must be stored at minus 80 degrees Celsius, which might be difficult in parts of West Africa.

Dr. Latour said Vaxart’s vaccine protected mice against Ebola but is only now being tested in monkeys. But an experimental flu vaccine developed using the same approach has already been tested in a small number of people. It generated immune responses comparable to or even better than approved flu vaccines, the company’s chief scientist said in a presentation last week at the World Vaccine Congress in Brussels.

Another company, Profectus BioSciences of Baltimore, received federal funding last week to move its Ebola vaccine toward clinical trials.

As public health officials warn that the Zika virus is swiftly spreading across the Americas, the search is on to develop a vaccine to halt the disease, which could infect as many as four million people by the end of the year and has been linked to severe birth defects.

[...]

Two major vaccine makers, the British company GlaxoSmithKline and Sanofi Pasteur, a French manufacturer, said this week that they were looking into the feasibility of developing a Zika vaccine by building on previous successes with other diseases.

GlaxoSmithKline developed a vaccine for Ebola, which showed success in early clinical trials and is still being tested. Last year, Sanofi received approvals for the world’s first vaccine for dengue, which is closely related to Zika. However, Sanofi sounded a note of caution this week, even as it said it would look into a Zika vaccine. “There are too many unknowns about Zika to reliably judge the ability to research and develop a vaccine effectively at this time,” it said in a statement.

A handful of smaller companies have also said they are working on Zika vaccines, some on more aggressive timelines. One team, a collaboration between [Inovio Pharmaceuticals, Incorporated], the South Korean company GeneOne Life Science and academic researchers in Canada and the United States, has said its product could be ready for emergency use by this fall. Two other companies, Hawaii Biotech and the [Protein Sciences Corporation], also announced plans for a Zika vaccine.

Meanwhile, public health officials said government researchers were working on at least two approaches to a vaccine and hoped to begin testing one of them in early clinical trials by the end of this year. That approach is a DNA vaccine method, which creates virus-like particles when it is placed into cells. The method was tried in a vaccine for West Nile, a related virus, and was found to be safe in early trials, but never progressed because the National Institutes of Health couldn’t find a company willing to develop it further, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases at the N.I.H.

Researchers will try the same approach with Zika by inserting a Zika gene into the same platform, in place of the West Nile gene. “I do not anticipate that we will have any problem partnering with pharmaceutical companies now,” he told reporters Thursday, referring to Zika.

Dr. Fauci added, however, “While these approaches are promising, it is important to understand that we will not have a widely available, safe and effective Zika vaccine this year and probably not even in the next few years.”

In a telephone interview Friday, Dr. Fauci said several factors could affect how long it would take for a vaccine to be approved, including how rampantly the disease spreads. A fast-moving disease, for example, would more quickly permit researchers to see if the vaccine is working.

Dr. Fauci said researchers were also eager to develop a rapid test to assess whether a person had been infected with Zika, to help pregnant women, in particular, find out if they have had the disease. A majority of people who are infected with Zika do not show any symptoms, and existing tests only seek out the active virus, which lasts in the body only for a short time. An easier-to-use test that looks for antibodies specific to Zika would be more useful, Dr. Fauci said, and he said academic researchers and some companies were exploring this avenue.

But even if the vaccine shows early success, drug companies — which have the capacity to manufacture large quantities of the product — must take an interest, he said, noting that earlier efforts to develop vaccines for West Nile and chikungunya, a related disease, have failed for lack of interest on the part of drug makers.

[...]

Sanofi, a French health care company, announced Tuesday it will acquire Protein Sciences Corp., a Meriden-based vaccines biotech company, for up to $750 million.

David Loew, Sanofi executive vice president and head of Sanofi Pasteur, Sanofi's vaccines division, said the acquisition will allow it to broaden its flu vaccine portfolio. The transaction gives Sanofi Flublok, a vaccine developed by Protein Sciences. Unlike traditional shots, it's not grown in eggs and can be produced to adjust to mutations in the flu virus.

Manon M.J. Cox, president and chief executive officer of Protein Sciences, said the company was "actively looking for an opportunity to grow its business, particularly in the U.S."

As part of Sanofi Pasteur, Protein Sciences expects Flublok to benefit from Sanofi Pasteur's expertise in the field of influenza vaccines, she said.

The company produces most of its Flublok doses in a facility in Pearl River, N.Y. By late 2015, it had produced 1.2 million 2015, but struggled with sales.

The purchase raises questions about Protein Sciences' future in Connecticut, which were not addressed in statements from the companies. Protein Sciences had about 100 employees in the state in late 2015.

The acquisition, which was unanimously approved by the board of directors of Protein Sciences and a majority of Protein Sciences shareholders, is expected to close in the third quarter. It must be approved by regulators.

Sanofi will initially pay $650 million and up to $100 million with unspecified milestones.

Sanofi's Pasteur unit, which generated about $5.21 billion in revenue last year, sells injections to protect against polio, flu and dengue and is currently developing a Zika vaccine, Bloomberg News reported.

Sanofi's stock rose less than 1 percent to 84.19 euros in Paris trading Tuesday.